Vol. 145, No. 8 — April 13, 2011
SOR/2011-82 March 25, 2011
FOOD AND DRUGS ACT
ARCHIVED — Regulations Amending the Medical Devices Regulations
P.C. 2011-444 March 25, 2011
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), hereby makes the annexed Regulations Amending the Medical Devices Regulations.
REGULATIONS AMENDING THE MEDICAL DEVICES REGULATIONS
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 and documents:
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 submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45.
(2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted 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 an establishment 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 submit an application for the review of their licence in accordance with subsection 46.1(1).
COMING INTO FORCE
4. These Regulations come into force on April 1, 2011, but if they are registered after that day, they come into force on the day on which they are registered.
N.B. The Regulatory Impact Analysis Statement for these Regulations appears, following SOR/2011-79, Fees in Respect of Drugs and Medical Devices Regulations.
S.C. 2005, c. 42, s. 2
R.S., c. F-27