Need an MHRA Certificate of Free Sale for Canada? Ginkgo Advisory helps UK exporters review the certificate, confirm the recipient’s instructions and prepare the appropriate professional authentication.
Our services include express solicitor certification for suitable documents, an express 2-working-day apostille service for eligible prepared documents, and embassy legalisation where needed. We confirm the required route and timing before work starts.
Does Canada require an MHRA CFS for medical devices?
Health Canada’s commercial-import guidance distinguishes product licensing from establishment licensing. It addresses Class I devices separately from Classes II, III and IV, with applicable exemptions. Determine the relevant Canadian obligations before choosing a supporting CFS package.
Consult Official information for Canada and ask Health Canada to clarify the particular document request.
Separate the device licence from the importer’s establishment licence
Ask the Canadian importer which device class and licence records concern the request. Health Canada distinguishes a Medical Device Licence (MDL) from a Medical Device Establishment Licence (MDEL). Check the manufacturer’s identity and the products on the CFS against the supporting Canadian records. Confirm any exemption through the Canadian regulatory team rather than assuming that a free-sale certificate supplies it.
Before arranging authentication, confirm:
- What device class does the Canadian file concern?
- Does the importer need an MDL, MDEL or both?
- Does it accept English or request French translation?
Illustrative example: A Canadian importer requests a CFS for a Class II device range. The exporter checks the listed models while the importer confirms the relevant MDL and its own MDEL obligations.
Solicitor verification and express certification
Our solicitor-led review checks the complete certificate, manufacturer details, product schedules and evidence of origin. We compare the package with the recipient’s instructions and identify discrepancies. Our express solicitor certification service covers suitable copies and supporting documents where the receiving body accepts that certification. A true-copy statement alone does not establish the issuer document’s authenticity.
MHRA electronic certificates need a specific check. The MHRA’s CFS guidance directs exporters to a notary for authenticity checks and any required notarisation before FCDO authentication of its electronically signed PDF. We identify that step during review. Solicitor certification cannot replace a required notarial act.
Express 2-working-day apostille for Canada
Our express UK apostille service applies to the eligible FCDO stage after the document is ready. Allow separate time for MHRA issuance, authenticity checks, professional preparation, translation and delivery. Any consular processing also takes additional time. Extra FCDO checks can affect the timetable.
An apostille authenticates the relevant signature, seal or stamp. It does not confirm product safety, expand the certificate’s product list or grant local market access. The UK government’s legalisation guidance explains the authentication process.
Apostille or embassy legalisation for Canada?
Canada appears in the HCCH Apostille Convention status table. For qualifying public documents, an apostille generally replaces consular legalisation where the Convention operates between the UK and the destination. Check the applicable treaty relationship and the recipient’s instructions for the actual document.
Some administrative documents that deal directly with commercial or customs operations fall outside the Convention’s scope. We assess the certificate and the professional act involved. If the applicable route requires further diplomatic authentication, ask about our embassy legalisation service.
Preparing your MHRA Certificate of Free Sale for Canada
Confirm whether the recipient accepts the English certificate or requests English or French, according to the recipient’s instructions. Ask which translation formalities apply and whether the translation must include the annexes, professional certification and apostille. Keep the original issuer PDF intact for authenticity checks.
- Send the complete issuer PDF and every product schedule, plus any existing professional certification.
- Include the written checklist, recipient’s name and address, intended use and required submission format.
- Provide the deadline, number of copies and delivery details so we can confirm the scope and quote.
Frequently asked questions
Can an apostilled MHRA CFS replace a Canadian MDL or MDEL?
No. These licences have separate functions under Canadian rules. The CFS and its authentication do not replace a device licence or an establishment licence where one is required.
Does the two-working-day service include the complete export process?
No. It concerns the eligible apostille stage after preparation. Certificate issuance, authenticity checks, any notarisation, translation, embassy work and delivery have separate timescales. We explain the complete requested package before you proceed.
Does an MHRA medical-device CFS cover medicines and cosmetics?
This service page concerns medical devices and in vitro diagnostic devices (IVDs). Medicines, cosmetics and other products can need different certificates. Send the actual document and product description so we can identify the appropriate document service.
Request a CFS document review for Canada
Contact Ginkgo Advisory with the certificate and recipient’s checklist. We will quote for suitable solicitor certification, any required professional preparation, the eligible express apostille stage and embassy legalisation where applicable.