Medical Devices Regulations (SOR/98-282)

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.

• 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 safety and effectiveness requirements.

• (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 safety and effectiveness requirements.

• (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.

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, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

• 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 safety and effectiveness requirements, 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.

• 36. (1) If the Minister determines that a medical device in respect of which an application is submitted meets the safety and effectiveness requirements, 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 safety and effectiveness requirements; 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.