Medical Devices Regulations (SOR/98-282)

Quality Management System Certificate

32.1 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.

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

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

32.4 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.

• 32.5 (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.

• 32.6 (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.

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.

Foreign Manufacturers

• 33 (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.

Application for a Medical Device Licence Amendment

34 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.

Additional Information and Samples

• 35 (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.

Issuance

• 36 (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.

Lot of In Vitro Diagnostic Devices

37 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.

Refusal to Issue

• 38 (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.

Requests by Minister

39 If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a licensed medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, samples — or an analysis or other information — to enable him or her to determine whether the device meets those requirements.

Suspension

• 40 (1) Subject to subsection (3), the Minister may suspend a medical device licence if the Minister has reasonable grounds to believe that

  • (a) the licensee has contravened these Regulations or any provision of the Act relating to medical devices;

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

  • (c) the licensee has failed to comply with the terms and conditions of the licence;

  • (d) the licensee has not complied with a request made under section 39 on or before the day specified in the request;

  • (d.1) the samples — or the analysis or other information — submitted by the licensee in response to a request made under section 39 are insufficient to enable the Minister to determine whether the medical device meets the applicable requirements of sections 10 to 20;

  • (e) the medical device no longer meets the applicable requirements of sections 10 to 20; or

  • (f) on the basis of information obtained after the device was licensed, the quality management system under which the device has been designed, in the case of a Class III or IV device, or manufactured, assembled, processed, packaged, refurbished or modified, in the case of a Class II, III or IV device, is inadequate to ensure that the device meets its specifications.

• (2) Before suspending a medical device licence, the Minister shall consider

  • (a) the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and

  • (b) the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.

• (3) Subject to section 41, the Minister shall not suspend a medical device licence until

  • (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, 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 licensee has been given an opportunity to be heard in respect of the suspension.

• 41 (1) The Minister may suspend a medical device licence without giving the licensee 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 licensee a notice in writing that states the reason for the suspension.

• (2) A licensee may ask the Minister, in writing, that the suspension be reconsidered.

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

41.1 The Minister may suspend a medical device licence if, after he or she has, under section 21.31 of the Act, ordered the licensee to conduct an assessment of the medical device in order to provide evidence establishing that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons,

• (a) the licensee has not complied with the order; or

• (b) the licensee has complied with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons.

42 The Minister may reinstate a medical device licence if the situation giving rise to the suspension has been corrected or if the reason for the suspension was unfounded.

Obligation to Inform

• 43 (1) Every manufacturer of a licensed medical device shall, annually before November 1 and in a form authorized by the Minister, furnish the Minister with a statement signed by the manufacturer or by a person authorized to sign on the manufacturer’s behalf

  • (a) confirming that all the information and documents supplied by the manufacturer with respect to the device are still correct; or

  • (b) describing any change to the information and documents supplied by the manufacturer with respect to the device, other than those to be submitted under section 34 or 43.1.

• (2) If the manufacturer fails to comply with subsection (1), the Minister may cancel the medical device licence.

• (3) If the holder of a medical device licence discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the discontinuance, and the licence shall be cancelled at the time that the Minister is informed.

Obligation to Submit Certificate

43.1 Subject to section 34, if a new or modified quality management system certificate is issued in respect of a licensed medical device, the manufacturer of the device shall submit a copy of the certificate to the Minister within 30 days after it is issued.

Disclosure of Information in Respect of Clinical Studies or Investigational Testing

43.11 In sections 43.12 and 43.13, information in respect of a clinical study or investigational testing means information in respect of a clinical study, or investigational testing, involving human subjects that is contained in an application for a Class III or IV medical device licence made under section 32 or in an application to amend such a licence made under section 34.