Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada (GUI-0097)

Date issued: January 18, 2023
Date implemented: January 18, 2023
Replaces: Guidance to apply for a manufacturer's certificate to export licensed medical devices from Canada (2019)

Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

Purpose

This document is a guide for companies in Canada who want to obtain a manufacturer's certificate to export (MCE) licensed medical devices from Canada. This certificate is also known as a certificate of free sale.

Issuing MCEs is not a regulatory requirement. It's a voluntary service provided to manufacturers by Health Canada's Regulatory Operations and Enforcement Branch (ROEB). There are currently no application fees associated with this service.

Scope

This guide is for manufacturers in Canada who plan to get an MCE in order to export medical devices from Canada to a foreign country.

MCEs will only be issued if you are located in Canada and hold 1 of the following licences or authorization:

medical device establishment licence (MDEL), issued to manufacturers of Class I medical devices
medical device licence (MDL), issued to manufacturers of Class II, III and IV medical devices
- Class I devices do not require an MDL and are instead monitored through MDELs
interim order (IO) authorization, issued to the manufacturer for the sale of Class I, II, III and IV COVID-19 medical devices

If you do not have the necessary licence or authorization and would like to apply for one, please download the appropriate form:

Background

Foreign governments or customers may ask companies exporting medical devices from Canada to supply a certificate. This certificate proves that their medical devices meet Canadian regulations and may be marketed in Canada.

ROEB issues these certificates as a voluntary service to the Canadian medical device industry. The certificates make it easier to export licensed medical devices. An MCE includes an attestation by both the manufacturer and Health Canada.

Before applying, you should confirm that your medical device licences and/or medical device establishment licences are valid. You can check their validity by using the following links:

establishment licences: medical devices establishment licence listing (MDEL)
device licences: medical devices active licence listing (MDALL)

IO authorizations are regulatory tools that Health Canada put in place to expedite access to COVID-19 medical devices. Medical devices authorized for sale under an IO may also be listed on an MCE form.

Before applying, you should confirm the validity of the IO authorization using the following lists of authorized medical devices for uses related to COVID-19:

Please note that industry, foreign regulators and the public can also validate an establishment licence, device licence or IO authorization by using the same online tools.

The medical device licence holder is responsible for marketing a safe and effective product. Issuing an MCE does not prevent Health Canada from taking regulatory action against the manufacturer of a medical device if needed.

Features of an electronic MCE

An MCE will be signed with an electronic signature that uses a certificate-based digital ID. This is used to authenticate the signer's identity and demonstrate proof of signing. The validity of the signature can only be viewed electronically.

The certificate will also be locked to:

protect the integrity of the certificate and prevent the document from being modified after it's signed
prevent the content in the certificate from being copied

Health Canada will email all electronically signed certificates only to the email address that was used to submit the application.

How to apply for an MCE

Who can apply

An MCE can only be requested by someone who is located in Canada and who is:

the manufacturer with an MDEL for Class I devices or
the MDL holder for Class II, III or IV devices or
the IO authorization holder for Class I, II, III and IV COVID-19 medical devices

Note: We do not issue MCEs for medical devices exported from Canada if the manufacturer has invoked section 37 of the Food and Drugs Act. Those devices will not have the required Canadian licensing.

How to apply

To apply to Health Canada for certification, you must:

complete the manufacturer's certificate to export licensed medical devices from Canada/free sale certificate form (FRM-0539)
submit the completed form by email to mce.questions-cfe@hc-sc.gc.ca

Note: Complete a single form for multiple devices you are exporting. If there isn't enough space, complete multiple forms. You must not modify the form.

How to complete the MCE form

You must provide the information noted in Table 1 for Parts 1, 2 and 3 on the first and second pages. The third page is for internal office use only. Note that we will only sign, issue and send certificates electronically.

**Table 1. Instructions on how to complete the MCE form**
Section of FRM-0539	Instructions
Part 1: Devices	For each licensed or authorized medical device that you intend to export, complete the licensing or authorization information for each medical device. For medical device(s) with an MDEL (Class I), provide the licence number and device name. For medical device(s) with an MDL (Classes II to IV), provide the licence number, device identifier, class of the device and device name. You may use page 2 of the form for additional medical device licences. For medical device(s) with an IO authorization, provide the authorization ID number, device name, authorization date and device identifier.
Part 2: Name and address of manufacturer	Provide the company ID, name and address for the manufacturer of the device(s). This should be the name of the MDEL, MDL or IO authorization holder in Canada.
Part 3: Signature of authorized person	An authorized person from the manufacturer must sign this section. Provide the name and title of the authorized person.
Page 3: Health Canada authorization	Office use only: An authorized Government of Canada representative will sign the form. Both signatures (including the company's) provide attestation to the validity of the electronic manufacturer's certificate.

To ensure the information in each cell is legible, please do not use a font size smaller than 9 point. If there isn't enough space (for example, for the device name), please use the next cell.

Approval or rejection of an MCE

What happens once you submit your application

Health Canada will review your application to make sure it's complete and meets all the requirements outlined in this guidance document. We will notify you if we find there are deficiencies.

We try to issue the certificates within a reasonable timeframe once we deem your form is complete. There is no service standard associated with this process.

You are responsible for making and selling a safe and effective product and providing clear instructions on how to use it properly.

At a minimum, this means the product must not be:

changed
manufactured in unsanitary conditions
manufactured, sold or advertised in a way that is false, misleading or deceptive
harmful to people's health

If we issue a certificate and your device becomes non-compliant, we will take action.

Refusal to issue a certificate

Health Canada may reject your request for an MCE for any of the following reasons:

application is incomplete and/or inaccurate
you do not have an active MDL or MDEL, or a valid IO authorization
form was changed
medical device cannot be legally sold in Canada
you are not the medical device manufacturer
incorrect class of medical device indicated on the form
company holding the MDL and manufacturer are not located in Canada
medical device is imported into Canada for packaging or labelling but is manufactured in a foreign country by a foreign manufacturer, who is the owner of the device
device was made for export only and not for use or sale in Canada under section 37 of the Food and Drugs Act

If your application is rejected

You may reapply if we rejected your application because:

your application was incomplete and/or inaccurate
you did not have the necessary MDL, MDEL or IO authorization

Before you re-apply, please correct the issue or apply for the necessary licence or authorization.

Request for authenticity, integrity or validity of a MCE

If a regulatory authority of the importing country has questions about the authenticity, integrity or validity of an electronic certificate issued by Health Canada, they may contact us directly at mce.questions-cfe@hc-sc.gc.ca. They must include the electronic certificate provided to them when sending the request to Health Canada.

We will reply to such requests as soon as possible. We will respond by providing a copy (electronically marked as duplicate) of the electronic certificate directly to the importing authority.

Request for wet-ink signature

If you are told by the country of destination that it will only accept the MCE if it's authenticated by Global Affairs Canada and legalized by their diplomatic representation in Canada, you must send an email to:

Authentication Services Section of Global Affairs Canada at docs@international.gc.ca

When emailing Global Affairs Canada, briefly explain your situation. They will send you an automated response with instructions on the next steps.

For more information (such as the service standard, status of your request and frequently asked questions), please visit Global Affairs Canada (authentication of documents).

Only use the MCE email account (mce.questions-cfe@hc-sc.gc.ca) for electronic applications. We will not answer any questions about a wet-ink signature sent to this email.

Contact us

Electronic MCE process: mce.questions-cfe@hc-sc.gc.ca
Wet-ink signature process: docs@international.gc.ca

Definitions

These definitions explain how terms are used in this document. If there is a conflict with a definition in the Food and Drugs Act or associated regulations, the definition in the act or regulations prevails.

Authorized person: The senior official or representative of your company.
Device: Any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in:
1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
2. restoring, correcting or modifying a body function or the body structure of human beings or animals
3. the diagnosis of pregnancy in human beings or animals
4. 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 or
5. preventing conception in human beings or animals
Medical device: A device within the meaning of the Food and Drugs Act, but does not include any device that is intended for use in relation to animals.
Medical device establishment licence (MDEL): A licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada. An MDEL is issued by the Regulatory Operations and Enforcement Branch (ROEB) of Health Canada after an establishment certifies that it meets certain requirements.
Medical device licence (MDL): An MDL authorizes manufacturers to import or sell Class II, III or IV medical devices. The Medical Devices Directorate issues an MDL in accordance with the Food and Drugs Act and the Medical Devices Regulations.

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