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Medical Devices Regulations

Version of section 38 from 2006-03-22 to 2016-07-16:

  •  (1) The Minister may refuse to issue or amend a medical device licence if

    • (a) the applicant does not comply with these Regulations or any provisions of the Act relating to medical devices;

    • (b) the applicant has made a false or misleading statement in the application;

    • (c) the medical device does not comply with the labelling requirements set out in sections 21 to 23; or

    • (d) the applicant has not complied with a request for additional information or samples made pursuant to section 35 by the day specified in the request.

  • (2) The Minister shall refuse to issue or amend a medical device licence if the medical device does not meet the safety and effectiveness requirements or if the information or samples provided pursuant to section 35 are insufficient to enable the Minister to determine whether the medical device meets those requirements.

  • (3) If the Minister refuses to issue or amend a medical device 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.

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