Medical Devices Regulations

45 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.