A Practical Guide to Legalisation and Apostille for UK MHRA CFS
1. Industry Background: Medical Devices Manufactured in China for Global Export
Mainland China has become a major manufacturing base for global medical device production. This growth comes from two sources: the rapid expansion of domestic manufacturers and multinational companies setting up factories in China.
Many China-based manufacturers now serve global supply chains, exporting their products to regions such as the Middle East, South Asia, Southeast Asia, South America, Africa, and parts of Europe.
Because these exports often enter markets with strict regulatory requirements, companies increasingly rely on internationally recognised documents — especially the UK Certificate of Free Sale (CFS) issued by the MHRA.
For export-driven manufacturers, the UK CFS has become an essential regulatory tool that supports smooth market entry and reduces compliance risks.
2. UK CFS vs China CFS: Key Differences
What the UK CFS Represents
The UK Certificate of Free Sale is issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
It confirms that:
- the medical device is placed on the UK market or permitted for sale, and
- it meets the requirements of the UK Medical Devices Regulations 2002, which align closely with the EU MDR/IVDR frameworks.
The MHRA issues the CFS in electronic PDF format with an electronic signature. Because it comes from a mature and internationally trusted regulator, the UK CFS carries high global credibility.
What the China CFS Represents
China has two main types of CFS-like documents:
- NMPA-issued regulatory documents — confirming domestic market approval.
- CCPIT-issued commercial certificates — confirming that a product can be freely sold within China.
These documents serve domestic compliance needs. However, they do not carry the same level of international regulatory recognition as the UK CFS.
3. Why the UK CFS Is Preferred Internationally
Many importing countries prefer the UK CFS for:
- medical device registration
- import licensing
- customs clearance
- market authorisation
This preference exists because of:
• the MHRA’s strong reputation
• alignment with global regulatory standards
• consistent and unified issuance
• acceptance once legalised through Apostille or embassy channels
In high-barrier markets, exporters often use UK CFS + Solicitor Certification + Apostille + Embassy Legalisation as a complete compliance package.
4. Why the MHRA CFS Cannot Be Directly Apostilled
The FCDO cannot Apostille the MHRA CFS directly because the CFS:
- is an electronic PDF,
- does not contain a wet signature, and
- lacks a physical seal that the FCDO can verify.
Apostille only validates the authenticity of a signature and the authority of the signer.
Therefore, before Apostille can be issued, the CFS must be converted into a form that contains a certifiable signature.
5. Why Solicitor Certification Is Required First
A solicitor or notary transforms the electronic CFS into a certifiable legal document. They do this by:
- reviewing the CFS
- verifying consistency with MHRA records
- issuing a legal statement confirming its authenticity
The combined set — the CFS plus the solicitor certification — becomes eligible for Apostille.
This step ensures that the foreign authority receiving the document can trust:
- who signed it,
- that the signature is valid, and
- that the document matches MHRA records.
6. The Full Certification and Legalisation Pathway
A complete UK CFS compliance pathway typically includes four steps:
Step 1 — MHRA issues the CFS
Electronic PDF format.
Step 2 — Solicitor Certification / Notarisation
A UK solicitor (SRA-regulated, FCDO-registered) certifies the document.
Step 3 — FCDO Apostille
The FCDO verifies the solicitor’s signature and issues the Apostille certificate.
Step 4 — Embassy Legalisation (if required)
Certain countries require embassy stamping in addition to Apostille.
Only after completing this pathway can exporters use the UK CFS for overseas regulatory procedures.
7. Key Markets Where UK CFS Is Used
Exporters rely on UK CFS when exporting medical products to markets such as:
- Pakistan
- Vietnam
- Argentina
- India
- Saudi Arabia
- United Arab Emirates
- Egypt
- Brazil
- Colombia
- Nigeria
- South Africa
- Thailand
- Malaysia
The UK CFS is also widely accepted in the Philippines, Indonesia, Bangladesh, Turkey, Kenya, Ghana, Chile, Peru, Mexico and Jordan, making it one of the most internationally recognised regulatory documents for medical device exports.
For manufacturers in China, the UK CFS significantly reduces compliance friction when entering these regions.
8. Cost and Validity Considerations
The validity of the UK CFS usually aligns with the underlying regulatory certification, so companies enjoy longer usable periods.
Chinese CFS certificates, especially commercial ones, may have:
- shorter validity
- frequent renewal requirements
- limited acceptance overseas
For exporters, this difference directly affects efficiency and regulatory risk.
9. Strategic Recommendations for Exporters
High-barrier markets
Use the full UK pathway:
CFS → Solicitor Certification → Apostille → Embassy Legalisation
Mid-barrier markets
UK CFS gives a strong advantage.
Chinese CFS may help but is rarely sufficient alone.
Low-barrier markets
Chinese CFS may be accepted but carries higher risk.
For high-value or high-risk devices, prioritising the UK pathway ensures smoother registration and stronger commercial stability.
10. Apostille and Additional Legalisation Services
Ginkgo Advisory supports exporters with:
• Verifying the authenticity of the UK CFS with MHRA
• Solicitor certification (SRA-regulated, FCDO-registered)
• Managing the full FCDO Apostille process
• Handling all embassy legalisation requirements
This end-to-end service ensures the resulting documents are fully accepted overseas so companies can focus on products and markets, not paperwork.
11. Conclusion
For companies manufacturing in China and exporting globally, the key challenge is not just producing documents, but ensuring that foreign authorities legally recognise them.
When combined with solicitor certification, Apostille, and embassy legalisation, the UK MHRA Certificate of Free Sale becomes a highly trusted and predictable pathway for international compliance.
It strengthens regulatory approval, reduces commercial risk, and supports long-term competitiveness in global medical device markets.
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