Medical Devices Regulations (SOR/98-282)

• 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.

Applications Submitted Under Part 1

68.2 Despite section 68.03, the holder of an authorization for a medical device may submit

• (a) in the case of a Class I device, an application under section 45 for an establishment licence that would authorize the holder to sell or import the device; or

• (b) in the case of a Class II, III or IV device, an application under section 32 for a licence for the device.

Cancellation

• 68.21 (1) The Minister may cancel an authorization for a medical device by written notice to the holder, giving reasons, if

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

  • (b) the Minister has reasonable grounds to believe that the risks associated with the device outweigh the benefits 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;

  • (c) the Minister has reasonable grounds to believe that the holder does not have 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;

  • (d) the Minister has reasonable grounds to believe that the health or safety of patients, users or other persons may be unduly affected by the device;

  • (e) the Minister has reasonable grounds to believe that the holder has failed to comply with the terms and conditions of the authorization;

  • (f) in the case of an authorization issued in respect of an application submitted on the basis of subsection 68.11(4), the Minister becomes aware that the authorization or licence for sale of the device that had been issued by the regulatory agency is suspended or revoked;

  • (g) the holder 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 cancel the authorization, within the time limit specified in the request;

  • (h) in the case of a Class I device that is not a UPHN medical device,

    • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, submit an application under section 45 for an establishment licence that would authorize the holder to sell or import the device,

    • (ii) the Minister refuses to issue an establishment licence to the holder under section 47, or

    • (iii) the holder withdraws the application referred to in subparagraph (i);

  • (i) in the case of a Class II device that is not a UPHN medical device,

    • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

      • (A) the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(2)(f), and

      • (B) the contract is in effect when that period expires, or

    • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f); or

  • (j) in the case of a Class III or IV device that is not a UPHN medical device,

    • (i) the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:

      • (A) the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(3)(j) or (4)(p), as the case may be, and

      • (B) the contract is in effect when that period expires, or

    • (ii) the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(3)(j) or (4)(p), as the case may be.

• (1.1) If a medical device ceases to be a UPHN medical device after an application for an authorization is submitted under section 68.11 but before the Minister issues the authorization under section 68.12, the reference to “the device ceases to be a UPHN medical device” in subparagraph (1)(h)(i), (i)(i) or (j)(i), as the case may be, shall be read as “the Minister issued the authorization”.

• (1.2) Subsection (1.1) ceases to apply in respect of the medical device if the device is authorized in relation to a medical condition that qualifies it as a UPHN medical device.

• (2) A ground for cancellation specified in subparagraph (1)(i)(i) or (j)(i) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be, or a copy of the contract referred to in the applicable subparagraph.

• (3) A ground for cancellation specified in subparagraph (1)(i)(ii) or (j)(ii) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be.