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Medical Devices Regulations

Version of section 45 from 2016-07-17 to 2018-12-28:


 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 devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of mandatory problem reporting;

  • (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 in Canada where the procedures described in paragraphs (g) to (i) are in place.

  • SOR/2011-82, s. 1(E)
  • SOR/2015-193, s. 6
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