Need an MHRA Certificate of Free Sale for United States? 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 United States require an MHRA CFS for medical devices?
FDA import guidance identifies requirements for foreign manufacturers and initial importers. The relevant route can involve establishment registration, device listing and a device-specific premarket submission or exemption. Confirm these separately from the CFS request.
Consult Official information for United States and ask US Food and Drug Administration (FDA) to clarify the particular document request.
Separate the buyer’s CFS request from FDA import requirements
Ask the US recipient whether it wants a CFS for its supplier records or for a specific submission. Identify the foreign manufacturer, US agent and initial importer rather than treating them as one role. Confirm the relevant device classification and regulatory pathway with the responsible US team. A professionally authenticated UK certificate cannot supply a missing FDA registration, listing or required premarket authorisation.
Before arranging authentication, confirm:
- Who requests the CFS and for what purpose?
- Which company is the initial US importer?
- Does the recipient specify paper authentication or another format?
Illustrative example: A US distributor asks a UK manufacturer for an apostilled CFS during supplier onboarding. The manufacturer checks that request while its US regulatory team handles the device’s separate FDA 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 United States
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 United States?
United States 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 United States
Confirm whether the recipient accepts the English certificate or requests English. 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 the FDA accept an MHRA CFS instead of US device authorisation?
No. The FDA explains that foreign regulatory authorisations do not replace applicable US requirements. A CFS can serve a separate documentary purpose, but its apostille does not grant FDA clearance or approval.
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 United States
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.