Medical Devices Regulations (SOR/98-282)

Regulations are current to 2013-04-29 and last amended on 2011-12-16. Previous Versions

Issuance

46. Subject to section 47, the Minister shall issue an establishment licence if the Minister determines that the application meets the requirements of section 45.

  • SOR/2011-82, s. 2.
Previous Version

Annual Review of Licence

  • 46.1 (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45.

  • (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

  • SOR/2011-82, s. 2.

Refusal

  • 47. (1) The Minister may refuse to issue an establishment licence if the applicant has made a false or misleading statement in the application.

  • (2) The Minister shall refuse to issue an establishment licence if the Minister has reasonable grounds to believe that issuing such a licence would constitute a risk to the health or safety of patients, users or other persons.

  • (3) If the Minister refuses to issue an establishment licence, the Minister shall

    • (a) notify the applicant in writing of the reasons for the refusal; and

    • (b) give the applicant an opportunity to be heard.

Notification

48. If, following the issuance of an establishment licence, there is a change to any of the information submitted in accordance with paragraph 45(a) or (b), the holder of the establishment licence shall submit the new information to the Minister within 15 days of the change.

Suspension

  • 49. (1) Subject to subsection (3), the Minister may suspend an establishment 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; or

    • (c) failure to suspend the establishment licence would constitute a risk to the health or safety of patients, users or other persons.

  • (2) Before suspending an establishment 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 50, the Minister shall not suspend an establishment 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.