Medical Devices Regulations

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.