ARCHIVED — Regulations Amending the Medical Devices Regulations

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Vol. 144, No. 46 — November 13, 2010

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health


For the Regulatory Impact Analysis Statement, see Fees in Respect of Drugs and Medical Devices Regulations.


Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), proposes to make the annexed Regulations Amending the Medical Devices Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Kendal Weber, Director General, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada, Address Locator: 2004A, Graham Spry Building, 250 Lanark Avenue, 4th Floor, Ottawa, Ontario K1A 0K9 (fax: 613-954-9981; email: cri_irc_consultations@hc-sc.

Ottawa, November 4, 2010

Assistant Clerk of the Privy Council



1. The portion of section 45 of the English version of the Medical Devices Regulations (see footnote 1) before paragraph (a) is replaced by the following:

45. A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information:

2. Section 46 of the Regulations is replaced by the following:

46. Subject to section 47, the Minister shall issue an establishment licence if the Minister determines that the application meets the requirements of section 45.

Annual Review of Licence

46.1 (1) The holder of an establishment licence that is not suspended shall file with the Minister an application for the review of their licence before April 1 in each year and include with it the information referred to in section 45.

(2) The Minister shall conduct an annual review of the licence on the basis of the information filed by the holder and any other relevant information in the Minister’s possession.

3. Section 51 of the Regulations is replaced by the following:

51. The Minister shall reinstate an establishment licence if the situation that gave rise to the suspension has been corrected or if the reason for the suspension was unfounded.


51.1 The Minister shall cancel a licence in either of the following circumstances:

(a) the licence has been suspended for a period of more than 12 months; or

(b) the licence holder has failed to file an application for the review of their licence in accordance with subsection 46.1(1).


4. These Regulations come into force on the day on which they are registered.


Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1