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Medical Devices Regulations (SOR/98-282)

Regulations are current to 2019-11-19 and last amended on 2019-06-17. Previous Versions

PART 1General (continued)

Class II, III and IV Medical Devices (continued)

Additional Information

 If the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s 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 a specified day, information or samples to enable the Minister to determine whether the device meets those requirements.

  • SOR/2015-193, s. 7

Suspension

  •  (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 for information or samples made pursuant to section 39 by the day specified in the request, or the information or samples provided 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.

  • SOR/2006-197, s. 4
  • SOR/2015-193, s. 7
  •  (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.

 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

  •  (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.

  • SOR/2003-173, s. 4

Obligation to Submit Certificate

 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.

  • SOR/2003-173, s. 5
  • SOR/2006-197, s. 4

Disclosure of Information in Respect of Clinical Studies or Investigational Testing

 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.

  • SOR/2019-63, s. 1
  •  (1) Information in respect of a clinical study or investigational testing that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the application:

    • (a) the Minister issues a licence under paragraph 36(1)(a);

    • (b) the Minister amends a licence under paragraph 36(1)(b);

    • (c) the Minister refuses to issue a licence or amend a licence under section 38.

  • (2) Subsection (1) does not apply to information in respect of a clinical study or investigational testing that

    • (a) was not used by the manufacturer in the application to support the information referred to in paragraph 32(3)(b) or paragraph 32(4)(b); or

    • (b) describes tests, methods or assays that are used exclusively by the manufacturer.

  • SOR/2019-63, s. 1

 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical study or investigational testing that has ceased to be confidential business information.

  • SOR/2019-63, s. 1

Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision

Application

 Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act.

  • SOR/2005-142, s. 2
  • SOR/2011-42, s. 1
Notices to Commissioner of Patents

 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s medical device meets the requirements of the Act and these Regulations if

  • (a) the manufacturer holds a medical device licence in respect of the device issued in accordance with section 36;

  • (b) the Minister is satisfied that the manufacturer and the device comply with the Act and these Regulations;

  • (c) the manufacturer has submitted to the Minister a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

  • (d) the manufacturer has submitted to the Minister information regarding the manner in which the mark referred to in paragraph 43.5(1)(a) is applied to all permanent components of the device; and

  • (e) the manufacturer has submitted to the Minister a sample of the label for the device that includes the information required by paragraph 43.5(1)(b).

  • SOR/2005-142, s. 2

 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s medical device referred to in section 43.2 has ceased to meet the requirements of the Act and these Regulations.

  • SOR/2005-142, s. 2
Marking and Labelling
  •  (1) No person shall sell a medical device referred to in section 43.2 unless

    • (a) the mark “XCL” is displayed on all permanent components of the device; and

    • (b) the label of the device displays the mark “XCL” followed by the control number referred to in paragraph 21(1)(d) and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”.

  • (2) The information required by subsection (1) shall be expressed in a legible, permanent and prominent manner.

  • SOR/2005-142, s. 2
 
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