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Medical Devices Regulations

Version of section 45 from 2021-06-23 to 2022-06-01:


 A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information and documents:

  • (a) the name and address of the establishment;

  • (b) the name, title and telephone number of the representative of the establishment to contact for any information concerning the application;

  • (c) a statement as to whether the activity of the establishment is importation or distribution, or both;

  • (d) the names and addresses of the manufacturers of the devices that are being imported or distributed;

  • (e) for each manufacturer, in respect of a medical device other than a decorative contact lens, the medical specialities in respect of which the device is imported or distributed;

  • (f) for each manufacturer, the classes of the devices that are being imported or distributed;

  • (g) an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of distribution records, complaint handling and recalls;

  • (h) if the establishment imports Class I medical devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of the making of reports under subsections 59(1) and (1.1);

  • (h.1) if the establishment imports Class II, III or IV medical devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of the making of reports under subsection 59(1) and the provision of information under section 61.2;

  • (i) if the establishment imports or distributes Class II, III or IV devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place, where applicable, for handling, storage, delivery, installation, corrective action and servicing in respect of those devices; and

  • (j) the address of each building where the procedures described in paragraphs (g) to (i) are in place.

  • SOR/2011-82, s. 1(E)
  • SOR/2015-193, s. 6
  • SOR/2018-225, s. 3
  • SOR/2020-262, s. 12
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