Medical Devices Regulations

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