Medical Devices Regulations (SOR/98-282)

• 43.12 (1) Information in respect of a clinical study or investigational testing that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the application:

  • (a) the Minister issues a licence under paragraph 36(1)(a);

  • (b) the Minister amends a licence under paragraph 36(1)(b);

  • (c) the Minister refuses to issue a licence or amend a licence under section 38.

• (2) Subsection (1) does not apply to information in respect of a clinical study or investigational testing that

  • (a) was not used by the manufacturer in the application to support the information referred to in paragraph 32(3)(b) or paragraph 32(4)(b); or

  • (b) describes tests, methods or assays that are used exclusively by the manufacturer.

43.13 The Minister may disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, any information in respect of a clinical study or investigational testing that has ceased to be confidential business information.

Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision

Application

43.2 Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act.

Notices to Commissioner of Patents

43.3 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s medical device meets the requirements of the Act and these Regulations if

• (a) the manufacturer holds a medical device licence in respect of the device issued in accordance with section 36;

• (b) the Minister is satisfied that the manufacturer and the device comply with the Act and these Regulations;

• (c) the manufacturer has submitted to the Minister a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

• (d) the manufacturer has submitted to the Minister information regarding the manner in which the mark referred to in paragraph 43.5(1)(a) is applied to all permanent components of the device; and

• (e) the manufacturer has submitted to the Minister a sample of the label for the device that includes the information required by paragraph 43.5(1)(b).

43.4 The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s medical device referred to in section 43.2 has ceased to meet the requirements of the Act and these Regulations.

Marking and Labelling

• 43.5 (1) No person shall sell a medical device referred to in section 43.2 unless

  • (a) the mark “XCL” is displayed on all permanent components of the device; and

  • (b) the label of the device displays the mark “XCL” followed by the control number referred to in paragraph 21(1)(d) and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”.

• (2) The information required by subsection (1) shall be expressed in a legible, permanent and prominent manner.

Notice to Minister

43.6 The manufacturer of a medical device referred to in section 43.2 shall notify the Minister in writing not less than 15 days prior to commencing the manufacture of the device.

Establishment Licence

Prohibition

• 44 (1) No person shall import or sell a medical device unless the person holds an establishment licence.

• (2) Subsection (1) does not apply to the importation or sale of a medical device by

  • (a) a retailer;

  • (b) a health care facility;

  • (c) in the case of a Class II, III or IV medical device, the manufacturer of the medical device; or

  • (d) in the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds an establishment licence.

• (3) Any person who imports a medical device shall ensure that the person from whom they import it holds an establishment licence.

• (4) Subsection (3) does not apply where a person imports

  • (a) in the case of a Class I medical device, from the manufacturer of that medical device if the person importing it holds an establishment licence; and

  • (b) in the case of a Class II, III or IV medical device, from the manufacturer of that medical device.

Application

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 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.

Issuance

46 Subject to section 47, the Minister shall issue an establishment licence if the Minister determines that the application meets the requirements of section 45.

Annual Review of Licence

• 46.1 (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45.

• (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

Refusal

• 47 (1) The Minister may refuse to issue an establishment licence if the applicant has made a false or misleading statement in the application.

• (2) The Minister shall refuse to issue an establishment licence if the Minister has reasonable grounds to believe that issuing such a licence would constitute a risk to the health or safety of patients, users or other persons.

• (3) If the Minister refuses to issue an establishment licence, the Minister shall

  • (a) notify the applicant in writing of the reasons for the refusal; and

  • (b) give the applicant an opportunity to be heard.

Notification

48 If, following the issuance of an establishment licence, there is a change to any of the information submitted in accordance with paragraph 45(a) or (b), the holder of the establishment licence shall submit the new information to the Minister within 15 days of the change.

Suspension

• 49 (1) Subject to subsection (3), the Minister may suspend an establishment licence if the Minister has reasonable grounds to believe that

  • (a) the licensee has contravened these Regulations or any provision of the Act relating to medical devices;

  • (b) the licensee has made a false or misleading statement in the application; or

  • (c) failure to suspend the establishment licence would constitute a risk to the health or safety of patients, users or other persons.

• (2) Before suspending an establishment licence, the Minister shall consider

  • (a) the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and

  • (b) the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.

• (3) Subject to section 50, the Minister shall not suspend an establishment licence until

  • (a) the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

  • (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

  • (c) the licensee has been given an opportunity to be heard in respect of the suspension.

• 50 (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent risk to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.

• (2) A licensee may ask the Minister, in writing, that the suspension be reconsidered.

• (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.

51 The Minister shall reinstate an establishment licence if the situation that gave rise to the suspension has been corrected or if the reason for the suspension was unfounded.

Cancellation

51.1 The Minister shall cancel an establishment licence in either of the following circumstances:

• (a) the licence has been suspended for a period of more than 12 months, or

• (b) the licence holder has failed to submit an application for the review of their licence in accordance with subsection 46.1(1).

Distribution Records

• 52 (1) The manufacturer, importer and distributor of a medical device shall each maintain a distribution record in respect of each device.

• (2) Subsection (1) does not apply to

  • (a) a retailer; or

  • (b) a health care facility in respect of a medical device that is distributed for use within that facility.

53 The distribution record shall contain sufficient information to permit complete and rapid withdrawal of the medical device from the market.

• 54 (1) The distribution record maintained by a manufacturer of an implant shall also contain a record of the information received on the implant registration cards forwarded to the manufacturer from a health care facility pursuant to section 67.

• (2) The manufacturer of an implant shall update the information referred to in subsection (1) in accordance with any information received from the health care facility or the patient.

55 The manufacturer, importer and distributor shall retain the distribution record maintained in respect of a medical device for the longer of

• (a) the projected useful life of the device, and

• (b) two years after the date the device is shipped.

56 Distribution records shall be maintained in a manner that will allow their timely retrieval.

Complaint Handling

• 57 (1) The manufacturer, importer and distributor of a medical device shall each maintain records of the following:

  • (a) reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada; and

  • (b) all actions taken by the manufacturer, importer or distributor in response to the problems referred to in paragraph (a).

• (2) Subsection (1) does not apply to

  • (a) a retailer; or

  • (b) a health care facility in respect of a medical device that is distributed for use within that facility.

58 The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out

• (a) an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and

• (b) an effective and timely recall of the device.

Incident Reporting

• 59 (1) The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring in Canada that involves the device if

  • (a) the device is sold in Canada; and

  • (b) the incident

    • (i) is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and

    • (ii) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur.

• (1.1) Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met.

• (2) The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.