Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information): SOR/2019-63
Canada Gazette, Part II, Volume 153, Number 6
Registration
SOR/2019-63 March 4, 2019
FOOD AND DRUGS ACT
P.C. 2019-134 February 28, 2019
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 footnote a of the Food and Drugs Act footnote b, makes the annexed Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information).
Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)
Amendment
1 The Medical Devices Regulations footnote 1 are amended by adding the following after section 43.1:
Disclosure of Information in Respect of Clinical Studies or Investigational Testing
43.11 In sections 43.12 and 43.13, information in respect of a clinical study or investigational testing means information in respect of a clinical study, or investigational testing, involving human subjects that is contained in an application for a Class III or IV medical device licence made under section 32 or in an application to amend such a licence made under section 34.
43.12 (1) Information in respect of a clinical study or investigational testing that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the application:
- (a) the Minister issues a licence under paragraph 36(1)(a);
- (b) the Minister amends a licence under paragraph 36(1)(b);
- (c) the Minister refuses to issue a licence or amend a licence under section 38.
(2) Subsection (1) does not apply to information in respect of a clinical study or investigational testing that
- (a) was not used by the manufacturer in the application to support the information referred to in paragraph 32(3)(b) or paragraph 32(4)(b); or
- (b) describes tests, methods or assays that are used exclusively by the manufacturer.
43.13 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical study or investigational testing that has ceased to be confidential business information.
Transitional Provisions
2 (1) Despite subsection 43.12(1) of the Medical Devices Regulations, information in respect of a clinical study or investigational testing, as defined in section 43.11 of those Regulations, that is confidential business information and that is contained in an application with respect to which one of the following circumstances occurred before the day on which these Regulations come into force ceases to be confidential business information on the day on which these Regulations come into force:
- (a) the Minister issued a licence under paragraph 36(1)(a) of the Medical Devices Regulations;
- (b) the Minister amended a licence under paragraph 36(1)(b) of the Medical Devices Regulations;
- (c) the Minister refused to issue or amend a licence under section 38 of the Medical Devices Regulations.
(2) Subsection (1) does not apply to information referred to in subsection 43.12(2) of the Medical Devices Regulations.
Coming into Force
3 These Regulations come into force on the day on which they are registered.
N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2019-62, Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information).