Guidance to apply for a Manufacturer's Certificate to Export licensed medical devices from Canada (GUI-0097)
- Version: 3
- 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 (GUI-0097), version 2 (November 21, 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.
On this page
- Features of an electronic MCE
- How to apply for an MCE
- Approval or rejection of an MCE
- Contact us
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.
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:
- Medical device establishment licence application form (FRM-0292)
- Medical device licence application and report forms (for each Class II, III and IV device)
- COVID-19 application form for authorization of importation or sale of medical devices
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:
- Authorized medical devices for uses related to COVID-19: List of authorized testing devices
- Authorized medical devices for uses related to COVID-19: List of authorized medical devices other than testing devices
- Authorized medical devices for uses related to COVID-19: List of medical devices for expanded use
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 email@example.com
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.
|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.
|Part 2: Name and address of manufacturer||
|Part 3: Signature of authorized person||
|Page 3: Health Canada authorization||
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:
- 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 firstname.lastname@example.org. 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 email@example.com
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 (firstname.lastname@example.org) for electronic applications. We will not answer any questions about a wet-ink signature sent to this email.
- Electronic MCE process: email@example.com
- Wet-ink signature process: firstname.lastname@example.org
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:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
- restoring, correcting or modifying a body function or the body structure of human beings or animals
- the diagnosis of pregnancy in human beings or animals
- 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
- 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.
- Guidance on medical device establishment licensing (GUI-0016)
- Guidance on medical device compliance and enforcement (GUI-0073)
- Importing and exporting health products for commercial use (GUI-0117)
Web pages and associated documents
- Date modified: