If your UK medical device or IVD Certificate of Free Sale (CFS) must be presented overseas, Ginkgo Advisory can coordinate document review, MHRA authenticity verification, appropriate solicitor certification, an eligible express FCDO apostille and further embassy attestation where required. The service is overseen by a solicitor of England and Wales. Requirements are assessed for the receiving country and authority, rather than assuming every destination follows the same process.
What is an MHRA Certificate of Free Sale?
The UK Medicines and Healthcare products Regulatory Agency (MHRA) issues CFS documents for eligible, registered medical devices and in-vitro diagnostics. The applicant generally must be a qualifying UK-based manufacturer, UK Responsible Person or Northern Ireland authorised representative. IVDs intended for performance evaluation cannot be included in CFS orders. Certificates are electronically signed PDFs, and the complete product schedules matter. A CFS is not a government endorsement or an export licence; importing countries decide whether to accept it.
MHRA verification and solicitor certification
We examine the original electronic file, its certificate reference, issue information, named parties, products and annexes. Where appropriate, we seek source confirmation from MHRA. Our solicitor can certify copies or make an accurate verification statement when the evidence and recipient's rules permit. A true-copy statement is not equivalent to independent issuer verification. We never claim that MHRA has verified a document unless that confirmation is actually obtained. We also check if the intended legalisation procedure specifically requires a notary.
Ginkgo solicitor certification
Express two-working-day FCDO apostille
Our express apostille option can take two working days for eligible, fully prepared documents, subject to acceptance and availability. Importantly, MHRA states that the FCDO cannot apostille its electronically signed PDF directly. MHRA's stated route involves a notary checking authenticity with MHRA and notarising the certificate before FCDO legalisation, where required. Solicitor certification is only appropriate where the relevant authority and legalisation route accept it; it must not be represented as a replacement for a required notarial act. The express timescale covers only the apostille stage after all preparatory work is complete.
Ginkgo FCDO apostille service · Official FCDO legalisation guidance
Embassy attestation for overseas use
An apostille may be sufficient in some destinations; others require consular, embassy or additional commercial-document formalities. Depending on the receiving authority, we can coordinate attestation routes involving the UAE, Qatar, Kuwait, Egypt and other countries, along with any necessary chamber checks or translation. We confirm requirements before taking payment or submitting originals. Authentication of a document does not amount to regulatory approval of a medical device or permission to import it.
Embassy attestation options · UAE · Qatar · Kuwait · Egypt
Documents and details to send us
Please send the complete original MHRA PDF, including all product schedules; identify the destination country, importer or authority and purpose of use; provide the recipient's written certification, attestation and translation instructions; and tell us your deadline and preferred return-delivery address. If a submission was previously rejected, include the rejection notice. We will distinguish certificate discrepancies requiring correction by the issuer from matters that can be addressed through certification or legalisation. Overseas courier return can be arranged separately.
Frequently asked questions
Can the original MHRA PDF receive a direct FCDO apostille?
No. MHRA states that its electronically signed PDFs are not authenticated directly by the FCDO. Its guidance describes notarial authenticity checks with MHRA followed by notarisation before legalisation, as required. We review the appropriate route before submission.
Does the whole service take two working days?
No. The express two-working-day option applies only to the eligible FCDO apostille stage. MHRA issuance, source checks, solicitor or notarial work, embassy processing, translation and international courier delivery take additional time.
Is embassy legalisation always necessary?
No. The document's destination, use and receiving authority determine whether an apostille alone is accepted or additional consular attestation is needed. We review these instructions rather than applying one rule to every country.
Request an MHRA CFS legalisation quotation
Ginkgo Advisory offers coordinated, solicitor-led MHRA document verification, suitable certification, FCDO apostille handling and optional embassy attestation. Share your complete certificate and written destination requirements for a tailored quotation and processing plan.