Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097)

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Our Mandate:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Supersedes: New document

Date issued: January 1, 2011

Date of implementation: January 1, 2011

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Table of contents

• 1.0 Purpose
• 2.0 Scope
• 3.0 Background
• 4.0 Definitions and Acronyms
• 5.0 Procedure
  • 5.1 Requirements for issuance of a Manufacturer's Certificate
  • 5.2 Refusal of Issuance of a Manufacturer Certificate
  • 5.3 Application Process
  • 5.4 Issuance of a Manufacturer's Certificate
• 6.0 Effective date
• 7.0 Reference Documents
• Appendix 1: Manufacturer's Certificate Exports of Medical Devices
• Appendix 2: Manufacturer's Certificate Export of Medical Devices Application Form Instructions

1.0 Purpose

This document provides guidance to manufacturers wishing to obtain, from Health Canada, a Manufacturer's Certificate to Cover Export of Medical Devices (MCE).

2.0 Scope

A Manufacturer's Certificate to Cover Export of Medical Devices is issued for medical devices that are legally for sale in Canada, which are intended for export to a foreign country and are currently licensed for use in Canada. The issuance of an MCE is not a regulatory requirement but rather a service to manufacturers provided by the Health Products and Food Branch Inspectorate (HPFBI), Health Canada. It cannot be issued for medical devices manufactured solely for the purpose of export of medical devices exempted under section 37 of the Food and Drugs Act.

3.0 Background

Companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification that their medical devices can be marketed in Canada and meet Canadian regulations. The HPFBI issues these certificates to a manufacturer to facilitate the export process as a service to the Canadian medical device industry. An MCE includes an attestation by both the manufacturer and by Health Canada.

It is the responsibility of the medical device licence holder to market a safe and effective product. The issuance of an MCE does not preclude Health Canada from taking regulatory action against the manufacturer of a medical device, if such an action is required.

The issuance of an MCE does not fall within the scope of the World Health Organization (WHO) Certification Scheme on the Quality of the Pharmaceuticals Products moving in International Commerce, recommended in resolution WHA22.50.

4.0 Definitions and Acronyms

Device Licence:

Medical devices imported or sold in Canada, with the exception of Class I medical devices are required to be licensed by Health Canada prior to being imported or sold in Canada.

FDA:

Food and Drugs Act

HPFBI:

Health Products and Food Branch Inspectorate

MDEL:

Medical Device Establishment Licence

Device:

any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

• (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
• (b) restoring, correcting or modifying a body function or the body structure of human beings or animals,
• (c) the diagnosis of pregnancy in human beings or animals, or
• (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring,
  and includes a contraceptive device but does not include a drug

5.0 Procedure

The form for Manufacturer's Certificate to Cover Export of Medical Devices is provided by HPFBI on request by the device licence holder for Class II, III, IV devices and manufacturer/exporter with an establishment licence (EL) for Class I device.

5.1 Requirements for issuance of a Manufacturer's Certificate

5.1.1 When a medical device is manufactured in Canada, a Manufacturer's Certificate can be issued if all the following requirements are met:

• the medical device has an active Canadian device licence for Class II, III and IV devices;
• the manufacturer of a Class I device has an active MDEL.

5.2 Refusal of Issuance of a Manufacturer Certificate

5.2.1 When a medical device licence holder is in a foreign country, no Manufacturer's Certificate will be issued.

5.2.2 When a medical device is manufactured in a foreign country and imported into Canada solely for the purpose of providing a contract packaging/labelling service to the foreign site that retains ownership of the medical device, no Manufacturer's Certificate will be issued.

5.2.3 A Manufacturer's Certificate will also not be issued when an application is incomplete or Section 37 of the FDA has been invoked.

5.3 Application Process

5.3.1 The applicant must fill out the "Manufacturer's Certificate to Cover Exports of Medical Devices Application Form" which is included in this document as Appendix 1. Instructions on how to fill out this form are included in this document as Appendix 2.

5.3.2 A single Application form can be filled out for exporting multiple medical devices.

5.3.3 Device licences for each specified Class II, III and IV medical device, in the application, should be attached to the Manufacturer's Certificate form when received by HPFBI.

5.3.4 The completed application form and supporting documentation is to be sent to:

• Health Product and Food Branch Inspectorate
• Establishment Licensing Unit
• Graham Spry, 2nd Floor
• 250 Lanark Avenue
• Address Locator# 2002A
• Ottawa, Ontario
• K1A 0K9

5.3.5 Certificates are mailed out via regular mail. To expedite the issuance of certificates, the applicant may include a completed shipping form (waybill Purolator, Fedex, Loomis, UPS, Dicom, etc.) with each request

5.3.6 For questions related to Manufacturer's Certificate to Cover Export of Medical Devices, please contact the Establishment Licence Unit at 613 954-6790 or by email at: MCE_questions_CFE@hc-sc.gc.ca

5.4 Issuance of a Manufacturer's Certificate

5.4.1 The HPFB Inspectorate has a target for issuance of Manufacturer's Certificates within 10 business days on receipt of complete information.

5.4.2 A seal is affixed on each page of the certificate. Each seal indicates in large fonts the year of issuance.

6.0 Effective date

This document will become effective on a date January 1, 2011

7.0 Reference Documents

•  Food and Drugs Act
•  Medical Devices Regulations
• Guidance on Medical Device Compliance and Enforcement (GUI-0073)
• Guidance Document on Medical Device Establishment Licensing (GUI-0016)
•  Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

Appendix 1: Manufacturer's Certificate to Cover Exports of Medical Devices

We, the undersigned, manufacturer of the following devices,

1. Devices :

   do hereby certify that

   • (a) each device is manufactured, produced and sold in Canada in accordance with the requirements of Canada's Food and Drugs Act and Regulations there under; and
   • (b) tests have been conducted in respect of each device and that the tests indicate that the nature of the benefits claimed to be obtainable through the use of each device and the performance characteristics of each device are justified.
2. Name of Manufacturer
3. Date

   Title and Signature of Authorized Person

4. Declared before me at [ ] this [ ] day of [ ] 20[ ].

   A Commissioner, Notary, etc.

   For office Use Only

   Health Canada
   Health Products and Food Branch

   It is hereby certified that

   • (a) devices manufactured, produced and sold in the manner above described would not, by reason of the method of manufacture thereof, be in violation of the Food and Drugs Act of Canada and the Regulations there under; and
   • (b) devices manufactured and sold in compliance with said Act and Regulations may be exported without restriction.
5. Date

   Title and Signature of Authorized Health Canada Representative

Appendix 2: Manufacturer’s Certificate to Cover Export of Medical Devices Application Form Instructions

The following information and declarative statement must be provided by the applicant when requesting a Manufacturer's Certificate. Clarifications regarding the sections of the Manufacturer's Certificate are provided below.

1. Devices:
   Provide the Device Name, Licence Number (for Class II, III & IV medical devices), Device ID/Catalogue Number of all the devices that will be listed under the corresponding Manufacturer Certificate Application.
2. Name of Manufacturer:
   Provide the Manufacturer Name or the name of the device licence holder, accompanied with the corresponding Establishment Licence.
3. Representative Signature:
   Dated, Title, and Signature of an authorized device licence holder's representative.
4. Notary Acknowledgement:
   The form must be signed by a notary public.
5. Health Canada Authorization:
   Office use only - Signature of an authorized Government of Canada representative, providing approval of the Manufacturer's Certificate.