Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices): SOR/2020-262

Canada Gazette, Part II, Volume 154, Number 26

Registration

SOR/2020-262 December 4, 2020

FOOD AND DRUGS ACT

P.C. 2020-980 December 4, 2020

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30footnote a of the Food and Drugs Actfootnote b, makes the annexed Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices).

Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices)

Food and Drug Regulations

1 The portion of subsection C.01.014.6(3) of the Food and Drug Regulationsfootnote 1 before paragraph (a) is replaced by the following:

(3) The Minister may cancel the assignment of a drug identification number for a drug if, after he or she has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(i) or (iii) to conduct an assessment of the drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

2 The portion of subsection C.01.050(2) of the French version of the Regulations before paragraph (a) is replaced by the following:

(2) Le titulaire d'une autorisation relative à un produit thérapeutique délivrée à l'égard d'une drogue appartenant à l'une des catégories mentionnées au paragraphe (4) fournit au ministre les renseignements dont il a reçu communication ou a connaissance concernant tout risque grave de préjudice à la santé humaine et se rapportant à la sécurité de la drogue en ce qui concerne :

3 (1) Subsection C.01.052(1) of the Regulations is replaced by the following:

C.01.052 (1) The Minister's power to make an order under section 21.31 of the Act in respect of a drug is subject to the following conditions:

(2) The portion of subsection C.01.052(2) of the Regulations before paragraph (a) is replaced by the following:

(2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a drug,

4 Section C.01.053 of the Regulations is replaced by the following:

C.01.053 The Minister's power to make an order under section 21.32 of the Act in respect of a drug is subject to the following conditions:

5 The portion of subsection C.08.006(3) of the Regulations before paragraph (a) is replaced by the following:

(3) The Minister may, by notice to a manufacturer, suspend for a definite or indefinite period a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(iii) to conduct an assessment of the new drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

Medical Devices Regulations

6 (1) The definition système de gestion de la qualité in section 1 of the French version of the Medical Devices Regulationsfootnote 2 is replaced by the following:

système de gestion de la qualité
Vaut mention de l'expression « système de management de la qualité » figurant à la norme nationale du Canada CAN/CSA-ISO 13485 intitulée Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires, avec ses modifications successives. (French version only)

(2) Section 1 of the Regulations is amended by adding the following in alphabetical order:

regulatory agency
means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (organisme de réglementation)

7 (1) Subsection 25(1) of the Regulations is replaced by the following:

25 (1) If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a Class I medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, an analysis or other information to enable him or her to determine whether the device meets those requirements.

(2) The portion of subsection 25(2) of the Regulations before paragraph (b) is replaced by the following:

(2) The Minister may direct the manufacturer to stop the sale of the medical device if

(3) Paragraph 25(2)(b) of the English version of the Regulations is replaced by the following:

(4) The portion of subsection 25(3) of the Regulations before paragraph (c) is replaced by the following:

(3) The Minister shall lift the direction to stop the sale if

8 (1) Paragraph 32(2)(f) of the Regulations is replaced by the following:

(2) Paragraph 32(3)(j) of the Regulations is replaced by the following:

(3) Paragraph 32(4)(p) of the Regulations is replaced by the following:

9 Section 39 of the Regulations and the heading before it are replaced by the following:

Requests by Minister

39 If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a licensed medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, samples — or an analysis or other information — to enable him or her to determine whether the device meets those requirements.

10 Paragraph 40(1)(d) of the Regulations is replaced by the following:

11 The Regulations are amended by adding the following after section 41:

41.1 The Minister may suspend a medical device licence if, after he or she has, under section 21.31 of the Act, ordered the licensee to conduct an assessment of the medical device in order to provide evidence establishing that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons,

12 Paragraph 45(h) of the Regulations is replaced by the following:

13 The heading before section 59 of the Regulations is replaced by the following:

Incident Reporting

14 Subsection 59(1) of the Regulations is replaced by the following:

59 (1) The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring in Canada that involves the device if

(1.1) Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met.

15 Subsection 61.1(1) of the Regulations is replaced by the following:

61.1 (1) Despite subsection 59(1) or (1.1), the manufacturer of a medical device may permit the importer of the device to prepare and submit the preliminary and final reports on the manufacturer's behalf if the information that the manufacturer and the importer must include is identical.

16 The Regulations are amended by adding the following after section 61.1:

Serious Risk of Injury to Human Health

61.2 (1) This section applies to a holder of one of the following therapeutic product authorizations:

(2) The holder of a therapeutic product authorization issued in respect of a medical device shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the device, regarding

(3) The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.

61.3 (1) Despite subsection 61.2(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer's behalf if the information that the manufacturer and the importer must submit is identical.

(2) The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer's behalf.

Summary Report

61.4 (1) The holder of a medical device licence shall prepare

(2) The matters to be covered by the summary report are

(3) The summary report shall contain a concise critical analysis of the information referred to in subsection (1).

(4) In preparing the summary report, the licensee shall determine, on the basis of the analysis referred to in subsection (3), whether what is known about the benefits and risks associated with the medical device has changed as described in any of the following paragraphs:

(5) The licensee shall include the conclusions they reach under subsection (4) in the summary report.

(6) If, in preparing the summary report, the licensee concludes that what is known about the benefits and risks associated with the medical device has changed as described in any of paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.

61.5 (1) The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of the device submit, on or before the day specified in the request, any of the following:

(2) The licensee shall submit to the Minister the summary reports or information, or both, that the Minister requests not later than the day specified in the request.

61.6 (1) The holder of a medical device licence shall maintain records of the summary reports and the information on the basis of which those reports were prepared.

(2) The licensee shall retain the records for seven years after the day on which they were created.

17 The Regulations are amended by adding the following after section 62:

Assessments Ordered Under Section 21.31 of the Act

62.1 (1) The Minister's power to make an order under section 21.31 of the Act in respect of a medical device is subject to the following conditions:

(2) The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a medical device,

Activities Ordered Under Section 21.32 of the Act

62.2 The Minister's power to make an order under section 21.32 of the Act in respect of a medical device is subject to the following conditions:

18 The heading before section 77 of the English version of the Regulations is replaced by the following:

Incident Reporting

19 Section 77 of the Regulations is replaced by the following:

77 The health care professional referred to in subsection 71(1) shall, within 72 hours after becoming aware of an incident that involves the medical device for which an authorization has been issued under section 72 and that meets the following conditions, report the incident to the Minister and to the manufacturer or importer of the device and specify the nature of the incident and the circumstances surrounding it:

20 Subparagraph 81(k)(v) of the Regulations is replaced by the following:

21 Paragraph 88(c) of the Regulations is replaced by the following:

22 The Regulations are amended by adding the following after section 88:

88.1 Subsections 61.2(2) and (3) and section 61.3 apply in respect of medical devices to which this Part applies except that the references to a holder of a therapeutic product authorization in those provisions shall be read as references to a holder of an authorization issued under subsection 83(1).

Coming into Force

23 (1) Subject to subsection (2), these Regulations come into force on the day that, in the sixth month after the month in which they are published in the Canada Gazette, Part II, has the same calendar number as the day on which they are published or, if that sixth month has no day with that number, the last day of that sixth month.

(2) The heading before section 61.4 and sections 61.4, 61.5 and 61.6 of the Medical Devices Regulations, as enacted by section 16 of these Regulations, come into force on the first anniversary of the day on which these Regulations are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Health Canada (the Department) has the authority to regulate the safety, efficacy and quality of drugs and the safety, effectiveness and quality of medical devices. Health Canada's authority is derived from the Food and Drugs Act (FDA), and its associated regulations, the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR).

Health Canada increasingly regulates drugs and medical devices from a life cycle approach whereby evaluation occurs throughout the life cycle (i.e. both before and after products reach the market). Regulatory agencies worldwide have adopted this approach in recognition that important information about the safety and effectiveness of drugs and medical devices can be learned only after a product is marketed and more people use it. However, Health Canada is currently limited in what it can require from medical device authorization holders once their products are approved for sale in Canada.

In 2014, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) [Vanessa's Law] amended the FDA to improve the safety of therapeutic products (drugs and medical devices) by introducing measures to, among other things,

Regulations regarding these provisions were introduced by Health Canada in 2017 and came into force in 2018 with respect to drugs; these regulations will now bring these provisions into effect for medical devices.

To appropriately implement a life cycle approach for medical devices, additional authorities are required to monitor devices once they are on the market. The Regulations will also

Finally, these Regulations will change the reference to the International Organisation for Standardization (ISO) standard for Quality Systems Management of medical devices, included in the MDR, to an ambulatory reference, thereby facilitating international harmonization and allowing certainty for medical device manufacturers.

Background

Vanessa's Law provisions that require supporting regulations

Power to issue orders

The amendments to the FDA through Vanessa's Law strengthen Health Canada's ability to collect post-market safety information and take appropriate action in situations where a serious risk to health is identified. While several amendments came into force immediately (e.g. the power to recall unsafe therapeutic products, the power to compel label changes and the possibility of tougher fines and penalties for contraventions), other powers require regulations to clarify their scope. These include the Minister's power to

These order powers are intended to be used to gather information to resolve uncertainties that may arise respecting the benefits and harms associated with a therapeutic product, in this case, medical devices. The power to order an “assessment” requires that an authorization holder determine the risk/benefit profile of a product by considering all the information that it currently holds. The power to order tests and studies or the monitoring of experience allows the Minister to require the authorization holder to create or compile new information in order to resolve uncertainties about safety and effectiveness. Uncertainties could be identified in new information that was not previously available to the Minister, such as a post-market safety signal obtained through a review of medical device incident reports. Without additional information to resolve the uncertainties, the Minister could not reasonably decide whether there was a significant change to the safety and effectiveness of the device that would constitute an elevated risk to patients and that could warrant further action to mitigate the risk. Regulations are required to clarify the circumstances and scope of the power that the Minister could exercise in orders made pursuant to sections 21.31 and 21.32.

Notifying Health Canada of foreign risk actions

Amendments to the MDR are necessary to support the receipt of more targeted and timely safety information regarding devices on the market in foreign jurisdictions and in Canada. Currently, Health Canada monitors the safety of medical devices for sale in Canada through the receipt of reports of incidents involving medical devices. The MDR require manufacturers and importers to submit reports of incidents that have occurred inside and outside Canada (subsection 59(1)). Subsection 59(2) specifies that incidents that occur outside Canada must only be reported if the regulatory agency of the country in which the incident occurred has required the manufacturer to take corrective action or if the manufacturer has indicated their intent to do so to the regulatory agency. The same reporting requirements apply to all classes of medical devices, from the lowest risk (Class I) to the most invasive devices (Class IV).footnote 4

The current information received by Health Canada on medical device foreign risk actions pursuant to section 59 does not meet Health Canada's needs as it is not timely, nor does it contain the most relevant information. Paragraph 60(1)(b) specifies that preliminary reports for incidents occurring outside Canada must be reported by the manufacturer or importer to Health Canada “as soon as possible” instead of specifying a clear timeline. Further, the MDR do not impose a timeline for the submission of a final report. Information submitted to Health Canada by manufacturers or importers focuses on the incident rather than the actions taken in response to the incident. Without timely and relevant information, Health Canada is hampered in its ability to act quickly if there is a serious risk to Canadian patients from a medical device.

Amendments made to the FDA as part of Vanessa's Law allow for the development of regulations requiring holders of medical device authorizations to provide the Minister with information on actions taken outside Canada relevant to medical devices marketed in Canada. Paragraph 30(1.2)(d) allows for regulations requiring the reporting of the following actions to Health Canada:

These Regulations will provide Health Canada with more targeted and pertinent information about actions taken in other countries in respect of serious risks of injury to human health for medical devices that are marketed in Canada. This is particularly important for actions that are typically not made public, such as reassessments, and that are therefore less likely to come to Health Canada's attention.

Having better information will permit Health Canada to follow up appropriately with either the medical device authorization holder or the foreign regulatory jurisdiction. It will also enable Health Canada to act sooner if there is a serious risk posed by the device. To implement the amendments, other sections of the MDR which require similar information (i.e. section 59 of the MDR) will be modified to ensure that there is no duplication.

Regulations to improve post-market surveillance

Summary reports

Amendments to the MDR are necessary to implement summary reports, a post-market vigilance tool that is lacking for medical devices. Similar reporting obligations are a requirement of the 2017 European Commission regulations for medical devices that will be fully implemented for most devicesfootnote 5 by May 26, 2021. Implementation of the European regulations was originally intended to take place by May 26, 2020, but was postponed by one year due to the COVID-19 pandemic. The addition of such requirements to the MDR will reflect international standards that support the post-market surveillance of medical devices.

Issue-related analysis of safety and effectiveness

Existing information-request provisions in the MDR, sections 25 and 39, allow Health Canada to request information or samples to determine whether the device meets the applicable safety and effectiveness requirements. The ability to require manufacturers to analyze these elements and submit their analysis in light of specific real world situations will facilitate better tracking and reporting of issues that can have an impact on the safety of devices for Canadians. Such requirements exist in the FDR (C.01.019), which allow Health Canada to request a critical analysis of a drug product for the purpose of post-market assessment.

Removing unnecessary burden: revising the reference to quality standards

The MDR require that medical device manufacturers provide copies of a quality management certificate to certify that they comply with the specified International Organization for Standardization (ISO) standard set out in the application section of the Regulations (section 32). Because the ISO standard is specifically mentioned in the Regulations by name, the Regulations must be amended each time the ISO standard changes. Given the global nature of medical device manufacturing and widespread use of the standard, manufacturers of medical devices undertake to revise their manufacturing processes once a change to the ISO standard is released; however, an amendment to the MDR is required in order to refer to the changed standard in Canada. Failure to amend the Regulations in a timely fashion will result in Canada continuing to refer to an outdated standard, while other countries have adopted the new ISO standard. This could lead to uncertainty for manufacturers and potential delay in medical devices being brought to the Canadian market. Section 30.5 of the FDA allows for regulations that reference a document that is amended from time to time (i.e. ambulatory reference).

Objectives

The objectives of the regulatory amendments are to

Together, the regulatory amendments will enable Health Canada to regulate medical devices more efficiently and effectively, based on a life cycle approach.

Description

Vanessa's Law provisions that require supporting regulations

These regulatory amendments add provisions to the MDR to support sections 21.31 and 21.32 of Vanessa's Law so as to fully operationalize the Minister's authority to order medical device licence holders to conduct an assessment, collect information, conduct additional tests and studies, and/or monitor experience. The Regulations will apply to medical device licence holders for Class II, III and IV medical devices. They will not apply to establishment licence holders for Class I medical devices, as these products are not licensed and establishment licence holders who import or distribute these products may not have access to the information required to conduct an assessment or carry out tests and studies.

The regulatory amendments also include amendments to the FDR to clarify the regulations currently in place with respect to the assessment power and the authority to require tests and studies for drugs. By amending the FDR, any potential inconsistencies or conflict in interpretation between the regulatory provisions for therapeutic products that are drugs and therapeutic products that are medical devices will be eliminated.

Assessments ordered under section 21.31 of the Act

An order under section 21.31 may be issued by the Minister when new information has surfaced and the Minister wants a new assessment of the risk/benefit profile of the product considering both the old and new information. The Regulations will establish the following with respect to an order made under section 21.31 of the Act:

Tests, studies and other activities ordered under section 21.32 of the Act

Orders for tests and studies may be used when the Minister deems that it is necessary for the medical device licence holder to monitor the benefits, harms and uncertainties of a device through conducting tests or studies, monitoring experience with the device or compiling information. The tests and studies order could be used to monitor benefits and harms associated with a device, for example, monitoring long-term complications with a device. The tests and studies provision could also address benefits and harms that are outside the stated use of a device or the parameters of the device licence, for example, when there are concerns regarding the risks of off-label device use. The Regulations will establish the following with respect to an order made under section 21.32 of the Act:

Activities specified in the order could include compiling information about the use of the device in other jurisdictions, conducting additional testing regarding the use of the device or monitoring the safety and effectiveness of the device on patients through a registry.

Notifying Health Canada of foreign risk actions

The MDR will be amended to require medical device licence holders and importers for Class II, III and IV medical devices to advise Health Canada when they, or certain foreign regulators, take any of the following actions outside of Canada with respect to a serious riskfootnote 6 related to a device on the market in Canada:

Medical device licence holders and importers for Class II, III and IV medical devices will be expected to set up systems to monitor the information above in relevant foreign jurisdictions and, as per the Regulations, will be required to notify Health Canada within 72 hours of receiving the information above. As a result, preliminary and final reports with respect to incidents in foreign jurisdictions under section 59 will be repealed for these classes of device. No product licences are issued with respect to Class I devices; however, the sale and import of Class I devices are subject to the medical device establishment licence requirements of the Regulations. Manufacturers and importers of Class I devices will continue to be subject to the reporting provisions for domestic and foreign reports that currently exist under section 59 of the MDR.

For Class II, III and IV medical devices, the intention is to limit the list of relevant foreign jurisdictions to foreign jurisdictions with regulatory bodies with which Health Canada has a Memorandum of Understanding or Mutual Recognition Agreement for medical devices and those countries that are part of the International Medical Device Regulators Forum. The relevant foreign jurisdictions will be set out in a document, the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations, which will be incorporated by reference into the Regulations to ensure flexibility should agreements or membership change over time. At the present time, the list contains 39 jurisdictions. Restricting the number of jurisdictions and specifying a timeline to report for medical device licence holders will provide Health Canada with targeted information from key regulatory partners and be less burdensome for reporting by medical device authorization holders. Section 59 of the MDR, which currently refers to the reporting of incidents involving medical devices that occur outside Canada, will be amended to align with the new foreign risk reporting requirements for Class II, III and IV medical devices.

Devices under investigational testing are currently subject to mandatory problem reporting requirements under section 59. The amendments will maintain the current requirements for Class I devices under investigational testing; however, the Regulations will be amended so that manufacturers and importers of Class II, III and IV devices that are authorized for investigational testing will be required to follow the new foreign reporting provisions.

Regulations to improve post-market surveillance

Summary reports

The Regulations will be amended to require medical device licence holders (i.e. manufacturers of Class II, III and IV devices) to:

(1) review the information they received under the Regulations or became aware of during either the previous 24 months (in the case of Class II devices), or the previous 12 months (in the case of Class III and IV devices), about the medical device related to

(2) prepare a summary report.

In preparing the report, licence holders will need to assess the benefits and risks of their devices and determine whether

If, after preparing the report, a licence holder finds that there has been a change in the risk-benefit profile of the medical device, they will be required to notify Health Canada in writing within 72 hours.

The requirement will also specify that

Additional information regarding the preparation of a summary report will be provided in guidance.

Issue-related analysis of safety and effectiveness

Sections 25 and 39 of the MDR will be amended to give the Minister the ability to require manufacturers of Class I devices and medical device licence holders for Class II, III and IV devices to prepare an analysis of an issue related to the safety and effectiveness of a device when requested to do so. The analysis will be requested when the Minister needs it in order to complete a post-market review of safety and effectiveness in response to a signal regarding the device. In keeping with the current requirements of sections 25 and 39, the Minister could request that the manufacturer provide analysis regarding a particular event or events related to the safety and effectiveness requirements set out in sections 10–20 of the Regulations. The intention is to provide details regarding the form of the analysis in guidance, which could include

Other additional information relating to the applicable safety and effectiveness standards could also be requested. Paragraph 40(1)(d) of the MDR will also be amended so that, should manufacturers fail to comply with a request for analysis pursuant to section 39, the Minister will have the ability to suspend the licence for devices from Class II through Class IV. The Minister will also have the discretion to order a stop sale of Class I devices (pursuant to subsection 25(2)) should a manufacturer not comply with a request for analysis pursuant to section 25.

Removing unnecessary burden: revising the reference to quality standards

Section 32 of the MDR will be amended to provide an ambulatory incorporation by reference to the ISO document that addresses quality management systems for medical devices.

Coming into force

These regulatory amendments, with the exception of the summary report requirements, will come into force 6 months after they are published in the Canada Gazette, Part II. The summary report requirements will come into force 12 months after the Regulations are published in the Canada Gazette, Part II, to allow for alignment with similar requirements in the European Commission's regulations, whose application date was postponed to May 26, 2021.

Regulatory development

Consultations

Consultations prior to prepublication in the Canada Gazette, Part I

Health Canada has engaged stakeholders extensively since 2010 to understand their various positions on the concepts underlying Vanessa's Law. For example, Health Canada hosted a series of three technical discussions with stakeholders in late 2010 and early 2011 on regulatory modernization and regulating drugs and medical devices based on a life cycle approach. These discussions covered topics such as terms and conditions, tests and studies, suspension, and revocation. Many of these components resulted in provisions found under Vanessa's Law. For more information on these technical discussions, visit Health Canada's website.

A notice of intent (NOI) was posted on the Health Canada website on April 10, 2018, announcing Health Canada's intention to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada, including regulations relating to Vanessa's Law. The NOI was also sent by email to all medical device licence holders (roughly 3 700 manufacturers of Class II, III and IV devices, both Canadian and foreign). Three stakeholders posed questions of clarification following the email, but none raised concerns with the proposals.

From May to July 2018, the regulatory proposals were presented at several events including two conferences held on May 16, 2018: the Canadian Association of Professional Regulatory Affairs conference and the biannual MedTech conference. Health Canada also discussed the proposal during a bilateral meeting with Medtech, formerly known as MEDEC,footnote 7 in May 2018. An additional webinar presentation was made to 60 representatives from Medtech companies on July 11, 2018, as part of a larger session on all device-related initiatives under the Regulatory Review of Drugs and Devices. Throughout these events, points of clarification were asked regarding the proposals, for example regarding the scope of applicable devices, timelines and how often Health Canada anticipates using the order powers. No negative feedback was received during these meetings regarding the nature or impact of these proposals.

In addition to the events held between May and July 2018, a webinar was held on November 22, 2018, with over 200 industry representatives. The purpose of the online information session was to provide additional details on the proposals to medical device manufacturers and importers. There were no comments received; however, participants did ask questions about the timing of the proposal and when draft regulations could be expected. Participants who were not able to participate in the webinar were sent the presentation materials and a link to the audio version of the webinar. Following the webinar, one set of follow-up questions was received regarding the anticipated use of the tests and studies provision. An update was given to Medtech on November 8, 2018, during a bilateral meeting between Medtech and Health Canada.

A costing survey was sent out on January 7, 2019, to all medical device licence holders and establishment licence holders for importation, those who hold establishment licences to manufacture Class I devices, and industry associations, to support the cost-benefit analysis. A webinar was held on January 15, 2019, to review the costing survey with industry, and to answer questions on the survey itself. Approximately 200 stakeholders dialled in to the presentation and were offered the opportunity to ask questions about the costing survey and the proposal. Some participants asked about the applicability of the provisions to different device classes but no negative comments were made about the proposal.

Summary of comments received during prepublication in the Canada Gazette, Part I

The proposed Regulations were prepublished in the Canada Gazette, Part I, on June 15, 2019, under their former title, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices). The title has since been changed to Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices) to align with current drafting standards. A supporting draft guidance document was also made available on Canada.ca. The Regulations and the guidance document were posted for a 70-day comment period, and the Department received comments from 28 different stakeholders. Respondents included 22 medical device manufacturers, 5 associations, and 1 patient advocacy group.

Overall, industry stakeholders were supportive of Health Canada's efforts. However, concerns were expressed over the annual reporting requirement for Class II devices, the absence of flexibility in reporting timelines, not including additional flexibility for grouping devices, the timelines for foreign risk notifications, the misalignment between Medical Device Single Audit Program (MDSAP) signatory countries, and the requirements placed on health care professionals accessing medical devices under the Special Access Program to report on incidents that occurred outside of Canada.

1. Medical Device Single Audit Program (MDSAP) and ISO 13485

Some industry stakeholders and industry associations were of the view that the requirement for summary reports does not provide any additional benefit to the safety of Canadians as the MDSAP audits manufacturers against the standards of ISO 13485, which requires continuous monitoring and risk management of devices. Since the globally accepted ISO standards require complaint handling and risk management processes to include regular trending and signalling tools to identify changes to the product risk profiles, the current ISO system is the timeliest tool for managing risks. Associations also stated that the new summary report requirement deviates from Health Canada's directive to have harmonized quality and reporting standards between MDSAP signatory countries, which include the United States, Australia, Brazil, and Japan. Currently, summary reports are not required by any other MDSAP signatory country, and as such, the associations stated that this specific Canadian requirement will place undue and unique burden on the Canadian industry, which could make it less competitive and innovative.

Health Canada response: Health Canada agrees with stakeholders that the ISO 13485 standard requiring continuous monitoring and risk management of devices covers the majority of the information that Health Canada is seeking. However, Health Canada maintains that in addition to this information it needs a manufacturer to conduct an aggregate analysis, prepare summary reports, notify Health Canada if there is a significant change associated with the risks and benefits associated with a device, and provide supporting information when requested. This is to better support the post-market safety and effectiveness of medical devices used by Canadians.

ISO 13485, which manufacturers of Class II, III and IV devices are required to follow under the MDR, already includes requirements related to the collection and analysis of post-market information that Health Canada would want included in a summary report. The summary report requirement is compatible with ISO 13485 and is not unreasonably burdensome as the collection and analysis of data is already built into manufacturers' quality management system. Furthermore, based on stakeholder feedback, Health Canada has made adjustments to the Regulations to reduce the burden associated with the summary report requirement (see below for further details).

MDSAP is designed to allow a single audit of manufacturers' quality management system to be acceptable to all participating regulators. The criteria used during MDSAP audits are ISO 13485 and the applicable regulatory requirements of the participating jurisdictions. As such, MDSAP audits cover regulatory requirements that are applicable to only certain jurisdictions but not others.

2. Summary reports

(i) Annual summary reporting for Class II devices

The majority of medical device stakeholders and all of the industry associations expressed concerns with the proposed annual reporting requirements for Class II devices. Stakeholders suggested that the requirements would be too burdensome for most device manufacturers, especially since it is not harmonized with similar requirements in other major jurisdictions (i.e. the European Union). In particular, stakeholders were concerned that requiring summary reports on an annual basis for Class II devices would put Canada at odds with other jurisdictions such as the European Union. Stakeholders strongly suggested that Health Canada harmonize the reporting period for Class II devices with that of the European Commission's new regulations to reduce the burden on the Canadian medical device industry.

Health Canada response: The Department has revised the Regulations to reduce the reporting requirements for Class II devices so that the reporting time period of the required report is harmonized with the requirement of the European Commission, being every other year. This will reduce the burden on industry while ensuring the Department receives the safety information that it requires.

(ii) Flexible reporting dates and device grouping for summary reports

Approximately half of the industry stakeholders and one association commented that the Regulations need to provide more flexibility to licence holders regarding the preparation date of the reports and the ability to group medical devices in summary reports. Industry commented that basing the date the reports should be prepared on the anniversary date of the Canadian device licence would bring them out of alignment with reports that are being created for other jurisdictions. In addition, stakeholders stated that each licence number having its own report instead of grouping devices where and when it makes sense in the same report would be too burdensome for industry.

Health Canada response: The Department acknowledges the operational challenges posed to licence holders and has amended the Regulations to provide additional flexibility for reporting dates. The amended Regulations no longer require report timelines to be based on the anniversary date for the Canadian device licence. Additional flexibility for the grouping of devices will be provided in guidance. As licence holders are the most knowledgeable about their devices, they are typically in the best position to determine how best to group their devices to conduct an aggregate analysis, as required by the summary report, to both track and identify changes in the risks or benefits of their devices. The changes made to permit the grouping of medical devices reduces unnecessary regulatory burden without compromising on a prudent approach to safety oversight.

3. Low-risk Class II medical devices

All of the industry associations that responded suggested that the Department should create an administrative list of low-risk Class II medical devices that are exempt from the summary report requirement. They stated that the low-risk Class II medical devices that are sold at retail, and do not require any intervention from a health care professional, should not be subject to the summary report requirements. Industry also suggested that including a requirement for all Class II medical devices (e.g. electric toothbrushes) was not consistent with a risk-based approach to regulating.

Health Canada response: The Department already applies a risk-based approach to regulating devices based on the classification system embedded within the MDR. The Department also took into consideration that licence holders of Class II devices regularly conduct ongoing risk management as part of their required compliance to ISO 13485. The Department is of the view that Class II devices are classified as such because they meet the risk profile of a Class II device based on past decisions and experiences. For this reason, the Department does not support the creation of a subclass of Class II medical devices. The regulatory amendments recognize the need for more of a risk-based approach to the summary report requirement for Class II devices by requiring reports for all Class II devices every two years, allowing greater flexibility in the timelines to prepare the reports, and allowing greater flexibility for grouping devices in reports.

4. Foreign risk notification timelines

A few industry stakeholders and one association commented that the timelines for foreign risk notifications would not always provide sufficient time for reporting to Health Canada. They suggested that the timeline should be revised from 72 hours to 10 days to permit them to assess whether or not the foreign risk notification is reportable for a particular device since devices may minimally vary across different jurisdictions, so the scope would need to be carefully examined. In addition, the regulatory requirements between the jurisdictions that the foreign actions occur in will also vary and impact the ability to report to Health Canada. For instance, if the difference between Canada and the foreign jurisdiction is only the language of the labels then the ability to report within 72 hours would not be anticipated to be an issue. However, since reporting requirements differ across international regulators, there will be several circumstances where it would not be workable to provide information to each regulator within 72 hours.

Health Canada response: The Department will maintain the 72-hour timeline for the foreign risk notification to minimize the negative impact of medical device problems that have been identified in a foreign jurisdiction with which Health Canada has a bilateral agreement. A 10- or 15-day reporting timeline to submit an incident report is typical for reporting internationally; however, the Minister must receive information in respect of an action taken to mitigate a serious risk of injury to human health that the licence holder receives or becomes aware of on an expedited basis to protect human health.

5. Health care professionals reporting incidents that occurred outside of Canada

An industry association commented that the approach of requiring health care professionals referred to under subsection 71(1) of the MDR (i.e. the special access program for devices) to provide foreign risk notifications is not a reasonable approach since health care professionals have little or no ability to learn of incidents occurring outside of Canada.

Health Canada response: After considering how unlikely it is that a health care professional would become aware of foreign risk notifications, the Department has removed the proposed requirement on health care professionals to report foreign risk actions affecting custom devices and medical devices imported or sold for special access, and devices authorized for investigational testing. The Department is always looking for meaningful ways to improve its understanding of devices and the impacts they have on Canadians, and it remains committed to taking a risk-based approach to safety oversight.

6. Costing of the Regulations

Two industry associations commented that Health Canada significantly underestimated the incremental costs of these Regulations. The most significant concern challenged the notion that the estimated incremental cost of the summary report requirements accurately reflects the costs that would be borne by stakeholders since the analysis assumed that there would be no additional cost associated with creating a report, but only with submitting it. In addition, the commenters noted that if the timing of the summary report preparation in Canada does not coincide with or provide enough flexibility to coincide with the timing of report preparation in other jurisdictions, there would be a cost to compile data specific to the reporting period in Canada. Several industry stakeholders and all of the associations mentioned that the requirement to prepare a summary report annually for Class II devices does not align with the biennial requirement in other jurisdictions, and the manufacturer would be obligated to prepare a Canadian-specific summary report; this would represent an incremental cost. Finally, the obligation to prepare a summary report per individual licence held by the manufacturer does not mirror the international standard where device manufacturers are permitted to group licences in preparing their summary report.

Health Canada response: The Department already requires manufacturers of Class II, III, and IV devices to follow the ISO 13485 standard. As part of that standard, manufacturers are already required to conduct ongoing risk management of their devices, and that information would be compiled to satisfy the summary report requirement.

The Department has revised the Regulations to provide more flexibility in the timing of summary reports to reduce unnecessary burden on manufacturers who market the same device in other jurisdictions, which will allow them to comply with their international and Canadian obligations with the same report. In addition, the reporting period for Class II devices has been amended to align with the European Union, and additional flexibility has been provided by allowing manufacturers to group similar licensed devices. In light of the changes made, Health Canada believes that the concerns identified have been addressed and that the original cost estimate of preparing the summary report should be maintained.

7. Patient advocacy and safety

One patient safety advocate commented that the end users of medical devices (i.e. patients) have not been given the resources they need to participate in the post-market surveillance of medical devices implanted in their body. They suggested that a stronger link needs to be made between patients, physicians, and regulators to ensure that patients have access to meaningful post-market surveillance in real time.

Health Canada response: Health Canada recognizes the importance to patients of participation in post-market surveillance, as well as having access to meaningful post-market information on medical device issues. While no changes were made to the Regulations in response to this comment as it is outside the scope of the Regulations, Health Canada notes that there are existing and recently introduced mechanisms that improve information sharing and support patient participation in post-market surveillance. Patients may participate in post-market surveillance by submitting a report to Health Canada on negative experiences with their medical device. Health Canada will use this information to identify problematic medical device trends. The Consumer Medical Device Report Form used to report a medical device incident can be found by visiting the Health Canada website. With respect to patient access to post-market surveillance information about medical devices, Health Canada continues to implement its Medical Device Action Plan, published in December 2018, which commits to providing more information to Canadians. As part of the Plan, the Department has been publishing incident data since January 2019 in order to communicate medical device issues to end users. The Department is committed to consulting on medical device projects with provinces and territories, patients, the health care community and industry to improve outcomes for all Canadians.

Additional stakeholder feedback

After the beginning of the COVID-19 pandemic and the decision by the European Commission on April 23, 2020, to delay the application date of the European Medical Device Regulation until May 26, 2021, Canadian medical device manufacturing stakeholders requested that the coming-into-force of the summary report requirement be delayed in order to align with the European requirement. The Regulations were revised to delay the coming into force of the summary report requirement by a further 6 months, to 12 months after publication in the Canada Gazette, Part II. This will delay their coming into force until late 2021.

Modern treaty obligations and Indigenous engagement and consultation

Indigenous peoples are not expected to be disproportionately impacted by these regulatory amendments.

Instrument choice

Health Canada considered regulatory and non-regulatory options including:

Status quo
1. Vanessa's Law order powers under sections 21.31 and 21.32 of the FDA

Vanessa's Law order powers under sections 21.31 (to require assessment) and 21.32 (to require tests and studies) of the FDA are not currently being used for medical devices. Regulations are required to clarify the circumstances and scope of the power that the Minister may exercise in orders made pursuant to sections 21.31 and 21.32.

2. Notifying Health Canada of foreign risk actions

The existing requirements specifying the content of the incident reports (subsection 60(2) and section 61 of the MDR) do not provide Health Canada with sufficiently detailed information regarding the corrective actions taken in the foreign jurisdictions and the potential impact of those corrective actions on medical devices in Canada. Furthermore, the existing Regulations specify only that the manufacturer should send in the reports “as soon as possible” (paragraph 60(1)(b) of the MDR) instead of a specific time frame.

3. Summary reports

Health Canada does not currently receive any information comparable to the summary report for medical devices. If the status quo is maintained, Health Canada will not have access to periodic analyses of incidents for Class II, III and IV medical devices.

4. Issue-related analysis of safety and effectiveness

While Health Canada currently requests some analytical information from manufacturers on a voluntary basis, there is no obligation for manufacturers to provide this information.

5. Revising the reference to quality standards

At the present time, the reference to the ISO standard is included directly in the Regulations and therefore, when the international standard is updated, it requires a change in the Regulations to reference the new standard. There is no non-regulatory option to address a change to the international standard.

Consideration of non-regulatory options
1. Vanessa's Law order powers under sections 21.31 and 21.32 of the FDA

The orders that the Minister may issue under sections 21.31 and 21.32 can be time-consuming and financially burdensome for authorization holders. A non-regulatory option could lead to uneven application of the order powers for devices. Further, it would be inconsistent with the approach for drugs, for which regulations were introduced in 2018.

2. Notifying Health Canada of foreign risk actions

After consideration, Health Canada determined that issuing guidance would not be sufficient to receive additional information about corrective actions resulting from incidents, due to the prescriptive nature of the existing incident report sections in the MDR. In addition, a non-regulatory approach would not be consistent with the approach taken for drugs and will therefore result in inconsistencies across product lines.

3. Summary reports

Health Canada considered using guidance for the summary report provision; however, in that instance, Health Canada would not be able to require manufacturers to notify when there was a change to the risk/benefit profile of a device. Given that this is an important safety component of this reporting requirement, Health Canada decided that a regulatory option is preferable.

4. Issue-related analysis of safety and effectiveness

Consideration was given to making issue-related analysis a guidance-based tool, but this was not the preferred approach for the following reasons: (1) Health Canada could not require manufacturers to provide analysis of the safety and effectiveness of their devices with respect to particular signals; and (2) Health Canada already has a tool that requires manufacturers to provide information when there is a question about safety or effectiveness, but it does not specify “analysis” and is therefore insufficient.

5. Revising the reference to quality standards

As described above, there is no non-regulatory option to address a change to the international standard that is referenced in the MDR.

Regulatory
1. Vanessa's Law order powers under sections 21.31 and 21.32 of the FDA

Regulations are the preferred option in order to specify how and when the Minister will be authorized to exercise these powers. They will set, in the MDR, the thresholds and procedures to be used with these powers. The Regulations are meant to ensure the effectiveness of the new provision of the Act and provide transparency while outlining procedural fairness steps for medical device licence holders.

2. Notifying Health Canada of foreign risk actions

Regulations are necessary for this provision, as the existing mandatory incident reporting requirements for foreign incidents do not provide sufficient information for licensed and higher-risk products.

3. Summary reports

Regulations are necessary as, in the absence of regulations, Health Canada would not be able to compel manufacturers to prepare summary reports and provide them to Health Canada when requested.

4. Issue-related analysis of safety and effectiveness

Given that sections 25 and 39 specify that information may be requested from manufacturers, amending the MDR will allow Health Canada to request an analysis of that information, and specify the time frame in which the manufacturer must submit the analysis.

5. Revising the reference to quality standards

As described above, currently, regulatory amendments are always required to address a change to the specific international standard that is referenced in the MDR. The ambulatory reference provision will eliminate the need for further regulatory amendments each time the international standard is changed.

Regulatory analysis

Benefits and costs

An analysis of the reported costs and benefits determined that the Regulations will have a low-cost impact on the medical device industry. This section provides a description of the methodology used in the analysis, a quantitative depiction of costs and a qualitative listing of potential direct benefits due to the regulatory package.

Table 1 outlines the incremental costs to industry should it be required to report on an incident involving a medical device under either of the two regulatory amendments. Costs reflect the average for each activity based on survey responses.

Table 1: Cost-benefit statement (in 2019 dollars)
  Stakeholder Base Year
Year 1		 Final Year
Year 10		 Total
(Present Value)		 Annual
Averagetable 1 note *
Quantitative impacts
Summary report Industry $228,900 $457,800 $3,211,573 $434,910
Analysis of safety and effectiveness Industry $486,150 $486,150 $3,653,530 $486,150
Total costs $715,050 $943,950 $6,865,103 $921.060

Table c1 note(s)

Table c1 note *

The annual average is the total cost over 10 years in current dollars, divided by 10.

Return to table c1 note * referrer
Methodology

A survey was drafted and distributed to over 4 000 potentially impacted stakeholders in order to determine the costs and benefits of the regulatory amendments; the survey was sent to industry associations, some establishment licence holders (importers and Class I device manufacturers) and medical device licence holders.

Responses were divided into two categories: those originating from Canada and those originating from outside of Canada. This categorization was used to determine the effect of the Regulations on Canadian respondents and to use foreign responses as a comparator to determine response validity. Health Canada estimates were used to determine the multiplier that best represented the number of potentially affected regulatees for each regulatory amendment in order to determine the total estimated cost to industry. The mean cost for each regulatory amendment was used as the basis for the cost calculation. The mean was further adjusted to account for outliers in the responses. These outliers were most likely due to respondents providing numerical values that represented the costs per activity for the entire company's product lines.

The formula for calculating the costs is as follows:

Madjust x N = cost of activity
Where
Madjust
represents the adjusted mean cost for a given activity; and
N
represents the number of times the activity is expected to occur each year.

Annual costs are presented over a 10-year period starting in 2020 and are discounted at 7%, as per Treasury Board requirements.footnote 8 Only costs that were determined to be incremental (i.e. outside of existing legislation and/or regulations) were included as being the cost of the regulatory proposal.

Costs

In the analysis and assessment of anticipated costs to industry, Health Canada only provided incremental cost estimates where new activities through the Regulations were identified. Activities that were already a requirement under existing regulations or legislation were not included in the final cost estimates. The net impact on government resources is not expected to be significant.

1. Vanessa's Law order powers under sections 21.31 and 21.32 of the FDA

The costs that will be imposed on manufacturers, should the Minister choose to exercise the power to require an assessment, a test or a study, stem from the Act and not the amendments (as was the case for similar regulations that were brought into force for prescription drugs)footnote 9. It is estimated that these powers may be exercised twice a year for assessments, and twice a year for tests and studies. The survey was used to ask stakeholders how much the incremental cost of the Minister's use of these powers will be. The average cost submitted from the survey responses to conduct an assessment was $42,484 and the average cost for additional tests and studies ranged from $76,137 to $769,384, depending upon the complexity of the request. However, as the costs are borne by the Act, they have not been included to calculate the net cost of the regulations.

2. Summary reports

Current ISO standard 13485 (Quality Management Systems for Medical Devices), and post-market reporting requirements in the European Union, instruct medical device manufacturers to compile information that Health Canada wants included in the summary report, such as an investigation into all reported complaints or significant changes in a device's risk-benefit profile. The Regulations specify that manufacturers will compile this information into a summary report with content specified by Health Canada. Therefore, there will be costs associated with the Regulation for Class II, Class III and Class IV device manufacturers if a report must be submitted. Following a review of input from the Canada Gazette, Part I, comment period, additional clarification has been made in both the Regulations and guidance to provide instruction for the frequency of the summary reports, flexible reporting dates, grouping of certain products under a single report and the ability to submit reports from other jurisdictions. Further, the coming into force period for this provision was extended to one year in order to allow alignment with the European Union.

With the Regulations in place, Health Canada expects to receive approximately 30 of these types of reports annually; this figure was determined by taking the average number of letters requested annually since 2013–2014. The cost estimate takes into account industry that is headquartered in Canada and those members of industry with Canadian staff, but that may be headquartered elsewhere. While similar regulations are underway in other regulatory jurisdictions and quality management standards require an ongoing record of changes in the risk-benefit profile of a medical device, the costs were still assumed to be a new activity. The cost calculation takes into account that while reports from other jurisdictions will be accepted, some additional work may be required. Based on survey responses and applying the mean adjustment to account for the outliers, the cost to industry per product report will be $15,260. This figure includes the collection and collation of reports, an analysis of the information, potential analytical adjustments for Canadian-specific risk-benefit changes, and the submission of the report (i.e. including internal approvals) to Health Canada. The total cost across all medical device manufacturers will be $457,800 per year in current dollars; however, due to the additional six months of the coming into force period for this provision, the cost in year one will be $228,900. The total present value (PV), discounted at 7% over a period of 10 years will be $3.2 million.

3. Amendments to sections 25 and 39: analysis of safety and effectiveness

The analysis, activities and processes that will be associated with the completion of these reports may be wide-ranging and infrequent, as they will be specific to an already identified risk communicated to the manufacturer by Health Canada. It is anticipated that in a given year, Health Canada will only ask a very small number of manufacturers to provide these reports, as the amendment is only intended to be used in the event that a signal has been identified by Health Canada and there is insufficient information to determine whether risk mitigation is necessary.

With the Regulations in place, Health Canada expects to request and receive approximately 30 of these types of reports annually; this figure was determined by taking the average number of letters requested annually since 2013–2014. Although some of these reports may be reported to Health Canada on a voluntary basis, in order to produce a conservative estimate, the costs are considered to be new activities. Based on survey responses, the mean adjusted (i.e. removal of outliers) cost per product report will be $16,205. Activities associated with the completion of these reports will include the collection of specified issue information and/or materials, the completion of an analytical report, and the submission of the report to Health Canada. The total cost to industry for this amendment will be $486,150 per year in current dollars or $3.7 million PV over a period of 10 years.

Benefits

There are a number of benefits associated with the amendments that, in concert, will improve Health Canada's ability to take risk mitigation measures when a risk is identified. The direct benefit of the Regulations is information gathering for the purposes of mitigating risk to health; this direct benefit cannot be quantified.

1. Ability to collect necessary risk data

Medical devices cover a wide range of classes, each with varying risk and benefit thresholds. While a number of vigilance reporting regulations are already in place, the Regulations will provide Health Canada with an additional means of collecting risk information. For example, when a potential risk comes to the attention of Health Canada, the Regulations will provide new measures to allow for the study of a specific issue related to the device.

2. Provide greater certainty to industry and critical information to Health Canada

Under the current Regulations, manufacturers may be asked to provide additional post-market information to Health Canada when a risk has been identified; however, they are not required to provide analysis. As a result, in the absence of the requirement for analysis, manufacturers may not provide Health Canada with critical analysis and Health Canada may face delays in receiving the specific information needed to perform a risk assessment. The amendment will eliminate any uncertainty by clarifying the type of information that Health Canada may ask for in a post-market analysis and how it ought to be presented. Further, the Regulations will specify when additional information could be requested and the form in which it must be presented, allowing industry to better prepare for requests for post-market reports.

3. Ambulatory reference to ISO 13485 standard

Survey responses indicated that industry was supportive of the amendment to include an ambulatory reference to the latest ISO 13485 standard. This will continue Health Canada's alignment of the Regulations with those of similar regulatory jurisdictions and allow industry to use a single audit standard in all of their markets. This will improve certainty for manufacturers and avoid potential delay in medical devices being brought to the Canadian market. It will also eliminate the need for a regulatory amendment each time the international standard changes.

4. Notifying Health Canada of foreign risk actions

Under section 59 of the MDR, medical device manufacturers are presently required to report to Health Canada incidents involving a medical device occurring inside or outside Canada. The regulatory amendments will limit the amount of information required in these reports and specify which jurisdictions manufacturers will be required to report on for products in Class II, III and IV. Because the MDR currently have a reporting requirement for actions in foreign jurisdictions and the Regulations will focus reporting to key international regulatory jurisdictions and specific activities for reporting, no new costs are anticipated. Health Canada currently receives approximately 900–1 000 reports per year. By specifying the reporting jurisdictions and providing a list of notifiable actions, the amendments are anticipated to reduce this figure to an average of 441 reports per year from all manufacturers in and outside of Canada.

5. More timely communication of risks

A component of Health Canada's mandate to help ensure the health and safety of the Canadian population through the regulation of the sale of therapeutic products is the timely communication of risks to Canadians. The Regulations will facilitate the communication of medical device risks by supporting the gathering of information of intrinsic value. Health Canada could then share the submitted information with Canadians through updates to product labelling, public statements, or information accessible by Canadians on the Government of Canada website. Similarly, by placing an emphasis on the analysis and study of the identified potential risk instead of simply reporting on the incident, industry will be in a stronger position to communicate their strategies to resolve the identified issue to Health Canada.

Total cost-benefit statement

Over a 10-year period, the Regulations represent an average annual cost burden on the medical device industry of $921,060 or $6.87 million PV over 10 years. This cost will be offset by a number of qualitative benefits that will increase post-market surveillance of medical devices and remove unnecessary burden to industry.

Small business lens

Primarily based in Ontario, Quebec and British Columbia,footnote 10 Canada's medical device sector is comprised of approximately 1 500 companies, employing 35 000 people;footnote 11 the sector is dominated by small and medium-sized enterprises (SMEs).footnote 10 Over half of its companies (57%) have fewer than 25 employees and 37% have 25 to 49 employees. Only 4% of companies hire 50 to 150 employees and fewer than 1% have more than 150 employees.footnote 12 Nearly 90% of the medical device facilities in Canada are Canadian-owned;footnote 12 however, foreign-owned global companies enjoy a larger share of the Canadian market.footnote 10

Canada's medical device sector is export-oriented, often bypassing the domestic market due to the stringent regulatory structures and relatively small market size.footnote 12 From 2011 to 2016, Canadian medical device exports increased from $1.8 billion to $3.1 billion.footnote 10 In 2016, Canada's medical device exports to the United States were $2.1 billion, or 67% of Canada's total medical device exports.footnote 10 Netherlands (4%), Germany (4%), and China (3%) ranked the next three largest export destinations for Canada's medical devices.footnote 10

Many small business respondents expressed general concerns about how increased regulation may negatively impact their business. The majority of the Canadian medical device industry is comprised of small business; approximately 40% of SMEs will be affected by the Regulations annually. Small business concerns were accounted for by designing the Regulations to promote good post-market surveillance that aligns with existing industry best practices. Furthermore, small businesses are already subject to some aspects of the Regulations. For example, they are required to report foreign incidents under the previous subsection 59(2). In addition, the collection and analysis of data needed to prepare a summary report is already built into a manufacturer's quality management system as per ISO 13485. For these reasons, further flexibility for small businesses, such as an exemption, was not considered to be appropriate or necessary.

The Regulations will only require additional action by small businesses in the event of there being a change in risk linked to a device. Industry survey responses indicated that the majority of devices sold in Canada are manufactured in foreign jurisdictions and only a relatively small product line of devices are produced by Canadian firms.

One-for-one rule

The Regulations include two provisions that would add new regulatory burden and one provision which would remove burden. The provisions will be a net “OUT” of regulatory burden for Canadian firms.

The entirety of the cost calculations represents an administrative burden due to the additional reporting requirements. Administrative burden calculations are aggregated from survey responses, and mean values are used in order to develop cost-per-activity figures. The average wage is $58 per hour, which is an average of all submitted staffing levels (i.e. all staffing levels presented as a single hourly wage) per industry respondent. It was necessary to use a single average hourly wage due to the high variability between the amount and level of staffing required. It will take industry respondents approximately 263 hours to complete the summary report and 279 hours to complete the analysis of safety and effectiveness; this represents the average time in hours to complete each type of report inclusive of all staffing levels. All reported wage costs are associated with the completion of the two required reports in the event that a change in a medical device risk occurs. The regulatory amendments for summary reports and issue-related analysis of safety and effectiveness will impose an administrative burden on industry. This will increase administrative burden by approximately $497,572 per year (2012 dollars, discounted to 2012), or $3,887 per firm.

Limiting reporting to a list of specified events in the foreign risk notification amendments is anticipated to reduce the overall administrative burden on firms identified as operating in Canada. A Canadian firm was identified as either having operations or staff in Canada. Using the 2018 reporting year as a proxy, the number of reports submitted by Canadian firms could be reduced by 55%, or 98 fewer reports annually. The reduction in the number of firms is due to changes to the requirements of notifiable events. This figure does not include changes to the number of reporting jurisdictions. This estimate is based upon the analysis of the total number of Canadian firms that provided a foreign risk notification and then examining which of these submissions would be in compliance with the new Regulations. Based upon survey information submitted by industry and an analysis of submitted reports to Health Canada, the average cost for submitting a report about foreign risk actions is $19,302 per report. This reduction would lead to an ongoing administrative savings of $1,892,772 and approximately 333 fewer hours to complete the reports. It should be noted there is high variability in the number of foreign risk notifications received each year by Health Canada. This will reduce administrative burden by approximately $1,029,543 per year (2012 dollars, discounted to 2012), or $8,043 per firm.

These Regulations will represent a net administrative burden “OUT” of $531,971 per year (annualized in 2012 dollars) or $4,156 per firm.

Regulatory cooperation and alignment

While these Regulations are not part of any existing formal regulatory cooperation initiative, they will provide for alignment with other jurisdictions in some cases, although they will create specific Canadian requirements in others. Analysis of the European and American medical device regulations was undertaken by Health Canada as part of the policy analysis for the Regulations. The analysis considered whether the regulations in Europe and in the United States would be appropriate for a Canadian context, and which regulations would yield the most robust post-market surveillance information for medical devices. Given the differences between the regulatory schemes for medical devices in Europe, the United States and Canada, not all regulations were deemed appropriate for the Canadian context.

Vanessa's Law provisions that require supporting regulations
1. Ability to request an assessment

No similar provisions were found in the European Union, Australia or the United States requiring manufacturers to conduct an assessment of their device at the request of the regulator in light of new information. Nevertheless, this provision is part of Vanessa's Law and is intended to be applied to therapeutic products in Canada, both drugs and devices. The ability to request an assessment will improve Health Canada's ability to regulate devices from a life cycle approach.

2. Ability to request tests and studies

The U.S. Food and Drug Administration (U.S. FDA) may issue requirements for manufacturers to conduct post-market tests and studies under section 522 of the Federal Food, Drug and Cosmetic Act. The Secretary may issue the order at the time of approval of a device or at any time thereafter. The order can only be applied to medium-to-high-risk devices. The regulations prescribe the amount of time allotted to the manufacturer to begin the study. The U.S. FDA may also take further action with regard to label changes or the marketing of the device once the term of study is complete.

The tests and studies provision will function in a similar manner to the studies requested by the U.S. FDA under section 522. The Minister will be able to issue the order at any point when new information points to new uncertainties about the safety and effectiveness of a medium-to-higher-risk medical device. The Minister will then be able to take further action depending on the results of the study.

3. Foreign risk notification

The provision on foreign risk notification can be compared to mandatory reporting requirements in the United States and Europe, which require manufacturers to report adverse medical device incidents and/or corrective actions that have occurred in other countries. The European Union regulations require manufacturers to have systems in place to report field safety corrective actions (FSCA). The American medical device regulations also require manufacturers to have systems to report both device incidents and FSCAs. Neither the United States nor the European Union have differing requirements for lower-risk devicesfootnote 13 as compared with these Regulations. While the United States and the European Union collect this information from all other countries, as will continue to be the case for Class I devices in Canada, for Class II, III and IV devices, these Regulations will limit the relevant jurisdictions as mentioned in the “Description” section above. This will ensure that Health Canada receives timely, targeted and high quality information without being unnecessarily burdensome on medical device authorization holders.

Regulations to improve post-market surveillance
1. Summary reports

In May of 2017, the European Commission passed new regulations (PDF) that set out more stringent post-market requirements for medical devices. Manufacturers must be in compliance with the new requirements by May 26, 2021, (2022 for in vitro diagnostic devices). As per these new Regulations, manufacturers of some medium-risk and all higher-risk devices must annually prepare a periodic safety update report, for each device, category or group of devices. Other medium-risk device manufacturers will be required to prepare a report biennially. Manufacturers of low-risk devices are exempt from this requirement. Manufacturers are required to report any statistically significant increase in the frequency or severity of (1) non-serious incidents or (2) expected undesirable side effects that could have a significant impact on the benefit-risk analysis.

The summary report provision under the MDR will set out similar requirements in that it only applies to medium-to-higher-risk devices, and that manufacturers are required to report increases in the frequency of device incidents or new incidents that are occurring. Certain medium-risk device manufacturers will be required to prepare a report every two years under Canadian regulations, which aligns with the European Commission's regulations.

The U.S. FDA has been shifting its surveillance model of medical devices toward a total product life cycle approach by leveraging expertise, data, knowledge and tools at all stages of a device's life. In addition, as part of this approach, the U.S. FDA is exploring regulatory options to streamline and modernize timely implementation of post-market mitigation.

The U.S. FDA also has an annual reporting regulatory mechanism for devices. This requirement is used as a condition of pre-market approval for Class III devices, the highest-risk class. The U.S. FDA has the authority to request supporting and additional information, including copies of the reports.

2. Issue-related analysis of safety and effectiveness

These amendments to the MDR are not modelled directly after European or American medical device regulations, but after existing Canadian drug regulations. The drug regulations function well in order to address issues raised through post-market safety assessments, so it was determined that this approach will also work well for medical devices, by amending the existing provisions.

Removing unnecessary burden: revising the reference to quality standards

This amendment will allow Canada to maintain regulatory requirements that are harmonized with those of its global trading partners, and allow current import and export schemes to remain in place. For example, the European Union uses the ISO standards, and the United States, while not formally referencing the ISO standard in their Quality System Regulations (QSR), replaced certain aspects of the existing QSR with specifications outlined in the most up-to-date ISO 13485 standard in spring 2019.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus (GBA+)

Evidence suggests that women are impacted differently than men by medical devices. There are numerous devices intended for use by women, such as breast implants, vaginal meshes and methods of birth control, which have caused many reported health problems from proper use, in Canada and abroad. Furthermore, there are differences in how devices intended for both sexes affect women. For example, one study found that women experience more hypersensitivity than men to metals used in joint implants,footnote 14 while another study found that women who received a particular type of cardiac implant were three times more likely than men to experience stroke.footnote 15

Some differences in how men and women react can be due to sex-related differences in anatomy (e.g. women's smaller heart size) or gender-related differences (due to many women's caregiving role, they may not take the same recovery time as men after implant surgery). Other groups, such as seniors and those with disabilities, also use devices more frequently than other populations. Therefore, changes in risk management for devices also affect them to a greater degree than they do for the general population.

Health Canada's pre-market work related to drugs and medical devices takes sex, gender and age into account through the drug and medical device review processes, and these processes will remain intact. Health Canada issued a guidance document in 2013 outlining key considerations for including women in pre-market studies for therapeutic products: Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences. Once therapeutic products are on the market, identified risks to particular groups such as women or children are taken into consideration, usually through additional risk management measures. For example, Health Canada has issued notices to the public and health professionals regarding additional risks present for children using pacemakersfootnote 16 and women using metal-on-metal hip implants.footnote 17

In May 2019, Health Canada launched a new expert advisory committee on women's health issues related to drugs and devices, in collaboration with the Canadian Institutes for Health Research.footnote 18

These Regulations will provide Health Canada with greater authority to compel information from manufacturers when there is evidence of a problem, including identified risks or uncertainties related to specific groups such as women, people with disabilities, or children.

Vanessa's Law provisions that require supporting regulations
1. Ability to request assessment

The Regulations will facilitate the exercise by Health Canada of its authority under section 21.31 of the FDA to compel medical device licence holders to reassess the risk/benefit profile of their products in light of new information, including information indicating that a certain group is disproportionately affected by a device (e.g. that women are experiencing a higher rate of stroke from a cardiac device). Based on the results of the medical device licence holder's assessment, Health Canada could take action such as a change to the device's labelling or revisions to the device's indications that would better protect that group with regard to the device.

2. Ability to request tests and studies

Similarly, the Regulations will facilitate the exercise by Health Canada of its authority under section 21.32 of the FDA to ask the medical device licence holder to monitor the impact of any device more closely, including products aimed at women, such as breast implants or vaginal mesh. Furthermore, the tests and studies provision could be used to request studies or information on uncertainties outside the parameters of the licence. This could include studies on off-label use, which could be targeted at pediatric populations, but also uncertainties related to any sub-population (e.g. women of childbearing age or postmenopausal women).

3. Notifying Health Canada of foreign risk actions

The Regulations to require medical device authorization holders to inform Health Canada about foreign risk actions could also be a valuable tool to support the health of specific sub-populations. Through this provision, Health Canada will receive information indicating corrective actions (recalls, communications of risk, labelling revisions, etc.) taken in other jurisdictions due to serious risk, including corrective actions due to an identified serious risk to sub-populations, such as those with disabilities, women, children, etc. By receiving this information in an expedited time frame (72 hours), Health Canada will then be able to better assess the risks to Canadians and take appropriate action (such as through a risk advisory, labelling revision, or recall).

Regulations to improve post-market surveillance
1. Summary reports

The Regulations on summary reports will require manufacturers to perform aggregate analyses of the incidents and problems identified with their device. These types of aggregate analyses could be used by manufacturers to both track and identify changes in the risks or benefits of their device, including risks posed to specific sub-populations.

2. Issue-related analysis of safety and effectiveness

The ability to request an issue-related analysis of the safety and effectiveness of a device will provide Health Canada with the ability to target issues relating to a device, including those affecting women or other sub-populations who might be differently affected by a medical device. For example, if scientific literature were to identify that women were experiencing adverse incidents at a higher rate than men in relation to a particular device, then Health Canada would be able to request an issue-related analysis from the manufacturer specific to that population.

Implementation, compliance and enforcement, and service standards

These amendments will not alter existing compliance and enforcement mechanisms under the provisions of the Act and the MDR. For example, if a manufacturer were to refuse to comply with an assessment order, the Minister could seek an injunction or recommend prosecution, which could result in the imposition of fines and penalties.

Health Canada intends to work with manufacturers to achieve compliance with all regulations by addressing issues and providing the necessary information to comply by way of guidance documents and corresponding templates.

To provide regulated parties with time to adjust to the Regulations, there will be a delayed coming into force as part of implementation. The Regulations, except for the summary report requirements, will come into force 6 months after they are published in the Canada Gazette, Part II. The summary report requirements will come into force 12 months after the Regulations are published in the Canada Gazette, Part II, to allow for alignment with similar requirements in the European Union, which have been postponed. Implementation activities, such as the training of staff, the development of standard operating procedures, as well as the updating of internal databases and Health Canada's website, will be needed to support these amendments. Resources for these few incremental implementation activities will be drawn from existing departmental funds.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca