Regulations Amending the Radiation Emitting Devices Regulations (Importation): SOR/2018-226
Canada Gazette, Part II, Volume 152, Number 23
SOR/2018-226 October 30, 2018
RADIATION EMITTING DEVICES ACT
P.C. 2018-1328 October 29, 2018
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 13(1) footnote a of the Radiation Emitting Devices Act footnote b, makes the annexed Regulations Amending the Radiation Emitting Devices Regulations (Importation).
Regulations Amending the Radiation Emitting Devices Regulations (Importation)
1 The Radiation Emitting Devices Regulations footnote 1 are amended by adding the following after section 3:
3.1 Any person who imports for sale or lease a device that is a medical device within the meaning of the Medical Devices Regulations and that is not labelled in accordance with these Regulations shall, before selling or leasing the device, ensure that the manufacturer of the device has relabelled it in accordance with these Regulations within three months after the date of its importation.
2 (1) Paragraph 4(1)(a) of the Regulations is replaced by the following:
- (a) detain the device or component for the time that is necessary to determine whether the device or component complies with the requirements set out in these Regulations;
(2) The portion of subsection 4(2) of the English version of the Regulations before paragraph (a) is replaced by the following:
(2) An inspector who seizes a device or a component of a device under subsection 10(1) of the Act shall sign and keep a written record of the seizure that sets out
Coming into Force
3 These Regulations come into force on the 60th day after the day on which they are registered.
N.B. The Regulatory Impact Analysis Statement for these Regulations appears following SOR/2018-225, Regulations Amending the Medical Devices Regulations (Importation).