If your importer requests an MHRA Certificate of Free Sale for Romania, send us the complete certificate and its instructions. Ginkgo Advisory reviews the document and confirms the appropriate UK preparation stages.
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 Romania require an MHRA CFS for medical devices?
Romania is an EU Member State. A UK CFS does not replace CE marking, applicable conformity assessment or the obligations of manufacturers, importers and authorised representatives. Treat it as supporting evidence when the actual recipient requests and accepts it. The European Commission’s medical-device guidance explains the wider regulatory framework.
A relevant national contact is National Agency for Medicines and Medical Devices of Romania (ANMDMR). Use the European Commission’s national authority directory to identify the appropriate team for the product and procedure. A tender or supplier-file request can differ from a regulatory submission.
Check the full manufacturer and device schedule for Romania
A Romanian file may reference a model family while the CFS lists individual products. Compare the application scope with every relevant annex entry. Confirm how the recipient wants translated descriptions and product codes presented. If several manufacturing locations appear in the supporting records, ask which location the CFS identifies and which location the submission concerns.
Before arranging authentication, confirm:
- Does every requested model appear in the annex?
- Which manufacturing site concerns the Romanian file?
- Does ANMDMR or a commercial recipient specify the evidence?
Illustrative example: A Romanian applicant requests proof for a range of examination devices. The exporter discovers that one new model does not appear on the CFS and resolves the omission before arranging authentication.
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 Romania
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 Romania?
Romania 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 Romania
Confirm whether the recipient accepts the English certificate or requests Romanian. 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 apostille extend a CFS to an additional model for Romania?
No. Authentication does not expand product coverage. The certificate must already cover the relevant model, or the issuer’s records and certificate need appropriate correction.
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 Romania
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.