Medical Devices Regulations (SOR/98-282)

Authorization

Non-application of Part 1 — Importation and Sale

• 68.03 (1) Despite section 8, Part 1 does not apply in respect of the importation or sale of a medical device if the manufacturer holds an authorization for the device.

• (2) However, the following provisions of Part 1 apply in respect of the importation or sale of the medical device:

  • (a) in the case of an importer, sections 59 to 61;

  • (b) in the case of an importer or distributor, sections 44 to 51.1; and

  • (c) sections 21, 23, 27, 52 to 58, 62 and 62.21 to 65.6.

• (3) Despite paragraph (2)(b), subsection 44(3) does not apply if the medical device that is imported is a Class I device and the person from whom the device is imported is the manufacturer.

Advertising — Authorized Class I Medical Device

68.031 No person shall advertise for the purpose of sale a Class I medical device for which the manufacturer holds an authorization if the device has been subjected to a change described in section 68.13 unless

• (a) the manufacturer holds an amended authorization; or

• (b) the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been authorized in accordance with Canadian law.

Deemed Authorization

68.04 [Repealed, SOR/2023-277, s. 8]

68.05 In sections 68.06 to 68.09, authorized, in relation to a medical device, means that the device is the subject of an authorization.

68.06 If a system is authorized, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to be authorized.

68.07 If a test kit is authorized, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to be authorized.

68.08 If a medical device or medical device group is authorized and forms part of a medical device family or medical device group family, as the case may be, all other medical devices or medical device groups in the family are deemed to be authorized.

• 68.09 (1) If all the medical devices that form part of a medical device group are authorized, that medical device group is deemed to be authorized.

• (2) If a medical device group is authorized, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to be authorized.

Application for an Authorization

• 68.1 (1) The Minister may add a medical condition to column 1 of Part 1 or Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that

  • (a) the medical condition presents, or is the result of, a significant risk to public health in Canada; and

  • (b) immediate action is required to deal with the risk.

• (2) The Minister may add a medical device to column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need for the device that is related to the corresponding medical condition that is set out in column 1.

• (3) The Minister may add a category of medical devices to column 2 of Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need for the devices that belong to that category that is related to the corresponding medical condition set out in column 1.

• 68.11 (1) A manufacturer of a medical device may submit to the Minister an application for an authorization for the device if it is a UPHN medical device.

• (2) The application shall be submitted in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to issue the authorization, including

  • (a) the name of the device;

  • (b) the class of the device;

  • (c) 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;

  • (d) the name and address of the manufacturer as it appears on the device label;

  • (e) the name and address of the establishment where the device is manufactured, if different from those referred to in paragraph (d);

  • (f) a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;

  • (g) information respecting the safety and effectiveness of the device;

  • (h) evidence that establishes that the manufacturer has a quality management system in place in respect of the device;

  • (i) the directions for use, unless directions are not required for the device to be used safely and effectively;

  • (j) an attestation by the manufacturer that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls; and

  • (k) a copy of the device label.

• (3) An application in respect of a Class III or IV medical device shall contain, in addition to the information and documents referred to in subsection (2),

  • (a) a description of the materials used in the manufacture and packaging of the device; and

  • (b) a list of the countries, other than Canada, where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and any recalls of the device in those countries.

• (4) Despite subsection (2) and subsection (3), the application need not include the information and documents referred to in paragraphs (2)(g) and (h) and, if applicable, subsection (3) if

  • (a) the application includes information that demonstrates that an authorization or licence for sale of the medical device has been issued by a regulatory agency and that the authorization or licence has not been suspended or revoked; and

  • (b) the name of the regulatory agency appears in the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.

Issuance

68.12 The Minister shall issue an authorization for a medical device if the following requirements are met:

• (a) the manufacturer has submitted an application to the Minister that meets the requirements set out in section 68.11;

• (b) [Repealed, SOR/2023-277, s. 10]

• (c) the Minister has sufficient evidence to support the conclusion that the benefits associated with the device outweigh the risks associated with it, having regard to

  • (i) the uncertainties relating to those benefits and risks, and

  • (ii) the urgent public health need for the device or the absence of any such need;

• (d) the Minister has sufficient evidence to support the conclusion that the manufacturer has a quality management system in place that is adequate to

  • (i) control the quality and, if applicable, the purity and sterility of the device and the materials used in the manufacture of the device, and

  • (ii) ensure that the device meets the specifications of the device; and

• (e) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the device.

Amendment

68.13 No person shall import or sell a medical device for which the manufacturer holds an authorization if the device has been the subject of any of the following changes unless the manufacturer holds an amended authorization:

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

• (b) a change that would result in a change of 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 I or II device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

68.14 An application to amend an authorization shall be submitted to the Minister by the holder of the authorization in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to amend the authorization, including the information and documents referred to in subsection 68.11(2) and (3) that relate to the change referred to in section 68.13 for which an amendment to the authorization is required.

68.15 The Minister shall amend an authorization for a medical device if the following requirements are met:

• (a) the holder of the authorization has submitted an application to the Minister that meets the requirements set out in section 68.14;

• (b) the Minister has sufficient evidence to support the conclusion that the benefits associated with the device outweigh the risks associated with it, having regard to

  • (i) the uncertainties relating to those benefits and risks, and

  • (ii) the urgent public health need for the device or the absence of any such need; and

• (c) the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the device.

Refusal

68.16 The Minister may refuse to issue or amend an authorization for a medical device if

• (a) the Minister has reasonable grounds to believe that the manufacturer has contravened these Regulations or any provision of the Act relating to medical devices;

• (b) the Minister has reasonable grounds to believe that the device is not labelled in accordance with sections 21 and 23; or

• (c) the manufacturer has not submitted to the Minister all information, documents or material that was requested under section 68.23 to enable the Minister to determine whether to issue or amend the authorization, within the time limit specified in the request.

68.17 The Minister shall refuse to amend an authorization for a medical device if the effect of the proposed amendment would be that the device would not be authorized in relation to at least one of the following medical conditions:

• (a) a medical condition that qualified the device as a UPHN medical device when the application for the authorization was submitted under section 68.11;

• (b) a medical condition in relation to which the device was authorized when the application to amend the authorization was submitted under section 68.14, in the case where

  • (i) the holder of the authorization previously submitted an application to amend the authorization under section 68.14 to have the device authorized in relation to the medical condition,

  • (ii) the medical condition qualified the device as a UPHN medical device when that previous application was submitted, and

  • (iii) the authorization was amended under section 68.15 on the basis of that previous application;

• (c) a medical condition in relation to which the device was not authorized when the application to amend the authorization was submitted under section 68.14, in the case where

  • (i) the holder of the authorization submitted the application to have the device authorized in relation to the medical condition, and

  • (ii) the medical condition qualified the device as a UPHN medical device when the application was submitted.

68.18 If the Minister refuses to issue or amend an authorization, the Minister shall notify the manufacturer of the medical device in writing of the reasons for the refusal and give them an opportunity to be heard.

Terms and Conditions

68.19 The Minister may, at any time, impose terms and conditions on an authorization for a medical device or amend those terms and conditions.