An MHRA Certificate of Free Sale for Japan should match the products, manufacturer and purpose of the receiving file. Ginkgo Advisory helps you review those details before arranging UK document 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 Japan require an MHRA CFS for medical devices?
PMDA explains that foreign manufacturers use the relevant Japanese applicant structure and follow a classification-based notification, certification or approval route. A UK CFS is supporting evidence only when the recipient requests and accepts it.
Consult Official information for Japan and ask Pharmaceuticals and Medical Devices Agency (PMDA) to clarify the particular document request.
Coordinate the CFS with the Japanese marketing authorisation holder
Ask the Japanese applicant to identify the device classification and the submission that needs the CFS. Product descriptions, catalogue numbers and manufacturer details should remain consistent across the English certificate and the Japanese file. Obtain the applicant’s translation instructions before commissioning work. A Japanese commercial product name may need a separate explanation rather than a change to the MHRA schedule.
Before arranging authentication, confirm:
- Which Japanese applicant will submit the file?
- What is the device’s intended regulatory pathway?
- How should Japanese names link to the original model codes?
Illustrative example: A Japanese marketing authorisation holder requests evidence for a family of diagnostic products. The UK manufacturer checks the listed models and confirms which Japanese translations and authenticated copies the applicant needs.
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 Japan
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 Japan?
Japan 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 Japan
Confirm whether the recipient accepts the English certificate or requests Japanese. 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
Does an apostilled CFS replace PMDA or MHLW procedures?
No. Japan’s route depends on the device and its classification. The applicant must address the relevant notification, certification or approval requirements independently of UK document authentication.
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 Japan
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.