Medical Devices Regulations (SOR/98-282)

Regulations are current to 2017-12-11 and last amended on 2017-02-13. 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.

 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.

  • SOR/2009-303, s. 2;
  • SOR/2011-322, s. 1.

Foreign Manufacturers

  •  (1) If an application for a medical device licence is submitted by a manufacturer of a country other than Canada, the information and documents described in subsections 32(2) to (4) need not be submitted if

    • (a) the applicant is governed, in that country, by a regulatory authority that is recognized by the Minister; and

    • (b) the application is accompanied by a certificate of compliance and a supporting summary report, issued by a conformity assessment body of that country that is recognized by the Minister, which certify that the medical device meets the applicable requirements of sections 10 to 20.

  • (2) For the purposes of subsection (1), the Minister may recognize a regulatory authority and a conformity assessment body of a country other than Canada only if it has the ability to determine whether the device meets the applicable requirements of sections 10 to 20.

  • (3) The Minister shall, on request, make available to any interested persons the list of recognized regulatory authorities and conformity assessment bodies of countries other than Canada.

  • SOR/2015-193, s. 7.

Application for a Medical Device Licence Amendment

 If the manufacturer proposes to make one or more of the following changes, the manufacturer shall submit to the Minister, in a format established by the Minister, an application for a medical device licence amendment including the information and documents set out in section 32 that are relevant to the change:

  • (a) in the case of a Class III or IV medical device, a significant change;

  • (b) a change that would affect the class of the device;

  • (c) a change in the name of the manufacturer;

  • (d) a change in the name of the device;

  • (e) a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

  • (f) in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

  • SOR/2015-193, s. 5.

Additional Information and Samples

  •  (1) If the information and documents submitted in respect of an application for a medical device licence or a medical device licence amendment are insufficient to enable the Minister to determine whether a medical device meets the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before a specified day, additional information necessary for making the determination.

  • (2) In the course of examining the application, the Minister may require the applicant to provide samples of the medical device.

  • SOR/2015-193, s. 7.

Issuance

  •  (1) If the Minister determines that a medical device in respect of which an application is submitted meets the applicable requirements of sections 10 to 20, the Minister shall

    • (a) issue to the manufacturer of the device a medical device licence, in the case of an application for a medical device licence; or

    • (b) amend the medical device licence, in the case of an application for a medical device licence amendment.

  • (2) The Minister may set out in a medical device licence terms and conditions respecting

    • (a) the tests to be performed on a device to ensure that it continues to meet the applicable requirements of sections 10 to 20; and

    • (b) the requirement to submit the results and protocols of any tests performed.

  • (3) The Minister may amend the terms and conditions of the medical device licence to take into account any new development with respect to the device.

  • (4) The holder of the medical device licence shall comply with the terms and conditions of the licence.

  • SOR/2015-193, s. 7.

Lot of In Vitro Diagnostic Devices

 No person shall sell a medical device from a lot of licensed in vitro diagnostic devices in respect of which terms and conditions were set out in the licence pursuant to section 36, unless

  • (a) the results and protocol of any test performed on the device in accordance with those terms and conditions have been provided to the Minister; and

  • (b) the Minister determines, on the basis of the information received under paragraph (a), that the device continues to meet the applicable requirements of sections 10 to 20.

  • SOR/2015-193, s. 7.

Refusal to Issue

  •  (1) The Minister may refuse to issue or amend a medical device licence if

    • (a) the applicant does not comply with these Regulations or any provisions of the Act relating to medical devices;

    • (b) the applicant has made a false or misleading statement in the application;

    • (c) the medical device does not comply with the labelling requirements set out in sections 21 to 23; or

    • (d) the applicant has not complied with a request for additional information or samples made pursuant to section 35 by the day specified in the request.

  • (2) The Minister shall refuse to issue or amend a medical device licence if the medical device does not meet the applicable requirements of sections 10 to 20 or if the information or samples provided pursuant to section 35 are insufficient to enable the Minister to determine whether the medical device meets those requirements.

  • (3) If the Minister refuses to issue or amend a medical device licence, the Minister shall

    • (a) notify the applicant in writing of the reasons for the refusal; and

    • (b) give the applicant an opportunity to be heard.

  • SOR/2015-193, s. 7.
 
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