Medical Devices Regulations (SOR/98-282)

Regulations are current to 2014-07-22 and last amended on 2011-12-16. Previous Versions

Quality Management System Certificate

 The Minister shall recognize a person as a registrar for the purpose of issuing, renewing, suspending or cancelling quality management system certificates if the person

  • (a) has sufficient training, experience and technical knowledge in the design and manufacture of medical devices and in the effective implementation of quality management systems to determine whether a quality management system satisfies a standard referred to in paragraph 32(2)(f), (3)(j) or (4)(p); and

  • (b) conducts quality management system audits and issues, renews, suspends and cancels quality management system certificates in accordance with the applicable guidelines and practices established by the International Organization for Standardization.

  • SOR/2003-173, s. 3;
  • SOR/2006-197, s. 3;
  • SOR/2009-303, s. 1.

 A quality management system certificate is valid for the period, not exceeding three years, specified in it.

  • SOR/2003-173, s. 3;
  • SOR/2006-197, s. 4.

 A registrar shall notify the Minister in writing within 15 days after suspending or cancelling a quality management system certificate.

  • SOR/2003-173, s. 3;
  • SOR/2006-197, s. 4.

 A registrar shall notify the Minister in writing within 15 days after the expiry of a quality management system certificate if the certificate has not been renewed.

  • SOR/2003-173, s. 3;
  • SOR/2006-197, s. 4.
  •  (1) Subject to subsection (2), the Minister may cease to recognize a person as a registrar if the Minister has reasonable grounds to believe that the person no longer meets the requirements of section 32.1 or fails to comply with section 32.3 or 32.4.

  • (2) Subject to section 32.6, the Minister shall not cease to recognize a person as a registrar unless

    • (a) the Minister has sent the registrar a written notice that sets out the reason for the proposed cessation of recognition, any corrective action required to be taken and the time within which it must be taken;

    • (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

    • (c) the registrar has been given an opportunity to be heard in respect of the proposed cessation of recognition.

  • SOR/2003-173, s. 3;
  • SOR/2009-303, s. 2.
  •  (1) The Minister may cease to recognize a person as a registrar without giving the registrar an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the registrar a notice in writing that states the reason for the cessation of recognition.

  • (2) A registrar may ask the Minister, in writing, that the cessation of recognition be reconsidered.

  • (3) The Minister shall, within 45 days after the date of receiving the request for reconsideration, provide the registrar with an opportunity to be heard.

  • SOR/2009-303, s. 2.