Manufacturers and 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. As a service to the Canadian medical industry, Health Canada through the Regulatory Operations and Enforcement Branch (ROEB) issues these certificates to facilitate the export process. The Manufacturer’s Certificate to Export licensed medical devices from Canada (MCE) includes an attestation by both the manufacturer and by Health Canada. To obtain an MCE, the following requirements must be met:
- the medical device is manufactured in Canada
- the medical device has an active Canadian device license for Class II, III, and IV devices, or
- the manufacturer of a Class I device has an active MDEL
Previously, the application process for MCE has been manual / paper-based with the applicant sending a completed and notarized application form as well as supporting documentation submitted to the Medical Devices Compliance and Licensing Unit of the Regulatory Operations and Enforcement Branch of Health by regular mail. Unfortunately, due to the impact of Covid-19 pandemic, Health Canada stopped processing requests for paper-based MCE.
Here comes the good news, Health Canada on January 5, 2022, announced the launch of the pilot program for electronic MCE (eMCE). This process will replace the suspended paper-based process that requires wet-ink signature from the company official. The new eMCE with e-signature is a more efficient process that offers a more environmentally friendly way of doing business. Aside from this benefit, eMCE will no longer require additional documentation, such as a cover letter, notarized form, and a copy of all listed licences. In addition, the new eMCE application form will produce a certificate entitled “MCE/Certificate of Free Sale”
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Steps to completing the new eMCE application form
- 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 a medical device establishment licence (Class I), provide the licence number, company ID and device name.
- For medical device(s) with a medical device licence (Class II-IV), provide the licence, device ID, Class of the device and the device name.
- For medical device(s) with an interim order authorization, provide the authorization ID, authorization date, device name, device ID and the manufacturer’s name.
- Provide the name and address for the manufacturer of the device(s). This should be the name of the MDEL, MDL or IO authorization holder.
- Submit a completed and electronically signed eMCE application with supporting documentation* to the Medical Devices Compliance and Licensing Unit of the Regulatory Operations and Enforcement Branch of Health Canada.
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- Class II, III or IV devices — a copy of the Medical Device Licence (MDL) for each device.
- Class I devices — a copy of the Medical Device Establishment Licence (MDEL).
- Class I, II, III or IV devices authorized under the IO — a copy of the IO authorization for each device as applicable.
Features of the eMCE
The eMCE will be digitally signed with an electronic signature that authenticates the signer’s identity and demonstrates proof of signing. The certificate will also be locked to protect the integrity of the certificate and prevent any modifications to the document from being made after it is signed and prevent the content in the certificate from being copied. The electronically signed certificates will be sent by email only to the applicant’s email address, which was used to submit the application.
The eMCE pilot project will last for 6 months from January 5, 2022.
Health Canada Launches Electronic Manufacturer’s Certificate to Export.
Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)