Regulations Amending the Radiation Emitting Devices Regulations (Importation): SOR/2018-226

Canada Gazette, Part II, Volume 152, Number 23

Registration

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)

Amendments

1 The Radiation Emitting Devices Regulations footnote 1 are amended by adding the following after section 3:

Importation

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:

(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).