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Medical Devices Regulations

Version of section 45 from 2006-03-22 to 2011-03-31:


 An application for an establishment licence shall be submitted to the Minister in a format established by the Minister and shall contain the following:

  • (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, the medical specialities, selected from among the specialities established by the Minister, in respect of which the devices are 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.


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