Vol. 146, No. 1 — January 4, 2012
Registration
SOR/2011-322 December 16, 2011
FOOD AND DRUGS ACT
Regulations Amending the Medical Devices Regulations (1667 — Miscellaneous Program)
P.C. 2011-1680 December 15, 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 (1667 — Miscellaneous Program).
REGULATIONS AMENDING THE MEDICAL DEVICES REGULATIONS
(1667 — MISCELLANEOUS PROGRAM)
AMENDMENT
1. Section 32.7 of the Medical Devices Regulations (see footnote 1) is replaced by the following:
32.7 The Minister shall reinstate the recognition of a person as a registrar if the situation that gave rise to the cessation of recognition has been corrected or if the cessation of recognition was unfounded.
COMING INTO FORCE
2. These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Issue and objectives
The amendment contained in this regulatory initiative pertains to section 32.7 of the Medical Devices Regulations (the Regulations). It addresses an observation made by the Standing Joint Committee on the Scrutiny of Regulations (SJCSR).
The objective of this regulatory initiative (Project 1667) is to amend section 32.7 of the Regulations to ensure that the reinstatement of recognition of a registrar is a requirement, if the situation giving rise to the cessation of recognition was corrected or proven to be unfounded.
Description and rationale
The Regulations set out the requirements governing the sale, importation and advertisement of medical devices. As part of the licensing process, manufacturers of Class II, III, and IV medical devices must provide Health Canada with the required safety, effectiveness and quality information, including a Quality Management System (QMS) certificate.
QMS certificates are issued by third-party certification bodies who certify that the processes related to the quality management system meet the applicable medical device-specific National Standard of Canada. These third-party certification bodies are formally recognized by Health Canada and are commonly referred to as recognized registrars.
The QMS provisions are found in sections 32.1 through 32.7 of the Regulations. These provisions outline the requirements for recognizing a person as a registrar, the activities of a registrar, length of time in which a QMS certificate may be valid, the registrars’ responsibility to inform the Minister of changes to a QMS certificate’s status, conditions surrounding the Minister’s discretion to cease to recognize a registrar, and situations giving rise to the Minister’s decision to reinstate the recognition of a registrar.
Section 32.7 currently states that “the Minister may reinstate the recognition of a person as a registrar if the situation giving rise to the cessation of recognition has been corrected or if the cessation of recognition was unfounded.” Section 32.7 will be amended to state that “the Minister shall reinstate the recognition of a person as a registrar if the situation that gave rise to the cessation of recognition has been corrected or if the cessation of recognition was unfounded.”
The benefit of this regulatory amendment is to provide clarity as to when the Minister shall reinstate the recognition of a person as a registrar.
This regulatory change is expected to have minimal, if any, costs since there are no increased requirements for industry or registrars; there is no impact on the public.
Consultation
This amendment responds to an observation made by the SJCSR concerning a prior regulatory amendment — Amendment to the Medical Devices Regulations (Project 1461 — Quality Management System Certificate).
Stakeholders have not had the opportunity to comment on Project 1667; however, no objections are expected since this amendment clarifies that that the reinstatement of recognition of a registrar is a requirement, if the situation that gave rise to the cessation of recognition was corrected or proven to be unfounded.
Implementation, enforcement and service standards
This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Medical Devices Regulations enforced by the Health Products and Food Branch Inspectorate.
Contact
Refer to project number: 1667
Policy Division
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator: 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-941-4623
Fax: 613-941-6458
Email: regaff-affreg@hc-sc.gc.ca
Footnote a
S.C. 2005, c. 42, s. 2
Footnote b
R.S., c. F-27
Footnote 1
SOR/98-282