A Practical Guide to MHRA CFS, Solicitor Certification, Apostille and Embassy Legalisation
1. The Core Role of the Certificate of Free Sale
The UK MHRA CFS (Certificate of Free Sale) is one of the most important documents in global medical device trade. It confirms that a product is legally placed on the market in the issuing country. For many regulators, customs authorities, and tender systems, the CFS serves as a proxy for:
- regulatory credibility
- manufacturing reliability
- product safety
- market authorisation status
Although many jurisdictions issue CFS documents, their acceptance, speed, cost, and legalisation workflow differ widely.
Over the past decade, the UK MHRA CFS has become one of the most trusted, cost-efficient, and widely recognised export documents globally.
2. The 5 Global Advantages of the UK MHRA CFS
2.1. Higher Global Recognition of UK MHRA CFS
The MHRA is one of the world’s most established medical device regulators. Its decisions are respected across:
- the Middle East
- Southeast Asia
- South Asia
- Africa
- South America
Many high-barrier markets explicitly prefer or require a UK MHRA CFS over certificates issued by smaller EU member states. For example:
- Saudi Arabia, Brazil, UAE, Egypt, and Nigeria frequently prioritise UK CFS
- Regulatory reviews often move faster with MHRA documentation
- Import agents and distributors trust MHRA-issued documents more than those from newer EU authorities
This recognition is one of the main reasons exporters choose the UK pathway.
2.2. Faster Issuance and Predictable Timelines
MHRA operates a highly streamlined CFS issuance system. Most applications proceed without additional document requests, and processing times remain consistent.
Exporters value this because:
- tenders often require rapid CFS submission
- some markets impose strict registration windows
- delays can cause commercial losses
In contrast, several EU authorities:
- impose document-by-document pre-screening
- request local-language translations
- require extra reviews when technical files were audited elsewhere
These steps add uncertainty. MHRA avoids them.
2.3. Lower Cost Compared with Many European CFS Options
UK MHRA CFS issuing cost:
- £75 per order (covers up to 10 certificates)
- £10 for each additional certificate
This means the real per-certificate cost is usually well below £100, even for multiple product lines.
European CFS issuing costs:
- There is no unified EU fee
- Publicly available data shows some authorities charge €250+ per order
- Many EU competent authorities do not publish clear fee schedules
Because UK MHRA CFS fees are low, predictable, and scalable, many SMEs choose it as their primary export certificate.
2.4. More Flexible Documentation Requirements
The UK MHRA CFS is simple and easy to prepare. Applications mainly require basic product and company information and confirmation that the device is marketed in the UK.
MHRA does not ask for additional technical files or clinical data during CFS application.
In the EU, documentation requirements differ by country. Some authorities may request:
- translations
- notarised technical documents
- administrative declarations
This increases time and cost.
MHRA’s predictable documentation requirements allow exporters to obtain CFS faster and with less preparation work, even when handling many products.
2.5. Unique Post-Brexit Advantages of UK MHRA CFS
Brexit created an unusual regulatory advantage for exporters.
UK CFS benefits include:
- recognition in global markets that view UK and EU standards as equivalent
- acceptance across Commonwealth and Middle Eastern markets
- usable even for products not yet listed in EU databases
- a more stable regulatory environment with early MHRA guidance
- lower long-term maintenance costs
Some EU authorities frequently update policies due to MDR/IVDR transitions, increasing compliance burdens. MHRA’s stability benefits SMEs significantly.
3. Why UK MHRA CFS Requires Solicitor Certification Before Apostille
MHRA issues CFS documents electronically.
Because they contain no wet signature or physical seal, the FCDO cannot Apostille them directly.
Apostille verifies:
- the authenticity of a signature
- the authority of the signer
- the validity of a seal
Since CFS documents are electronic, a solicitor must first:
- review and validate the document
- certify the PDF as a true copy
- issue a legal declaration
Only after this step can the FCDO issue an Apostille.
Some markets also require embassy legalisation.
Standard workflow:
- UK MHRA issues the CFS
- Solicitor certification (SRA-regulated, FCDO-registered)
- FCDO Apostille
- Embassy legalisation (where required)
Once completed, the documents are recognised by regulators, customs authorities, and tender offices worldwide.
4. Key Markets That Rely on UK MHRA CFS
The UK CFS is widely used to export medical devices to:
- Pakistan
- Vietnam
- Argentina
- India
- Saudi Arabia
- UAE
- Egypt
- Brazil
- Colombia
- Nigeria
- South Africa
- Thailand
- Malaysia
It is also widely accepted in:
the Philippines, Indonesia, Bangladesh, Turkey, Kenya, Ghana, Chile, Peru, Mexico and Jordan.
This makes the UK MHRA CFS a powerful single-document solution across Asia, Africa, the Middle East and Latin America.
No other CFS offers comparable consistency and global reach.
5. When Companies Should Prioritise UK CFS
UK CFS is the optimal choice when:
- entering markets with high regulatory scrutiny
- submitting tender documentation under tight deadlines
- working with limited compliance budgets
- requiring documents that are easily Apostilled or legalised
- exporting multiple SKUs and needing predictable costs
EU CFS may be preferred when:
- the destination country explicitly requires EU-issued CFS
- the product is registered in the EU but not yet in the UK
For most exporters, however, UK MHRA CFS provides superior flexibility, speed, and cost efficiency.
6. How Ginkgo Advisory Supports Exporters
Ginkgo provides an end-to-end solution for MHRA CFS legalisation:
• Verification
Confirming the authenticity of the UK CFS with MHRA.
• Solicitor Certification
Performed by our UK-qualified solicitor (SRA-regulated, FCDO-registered).
• Apostille Management
Handling the full FCDO Apostille process with tracking.
• Embassy Legalisation
Coordinating additional stamping for markets that require it.
The result is a legally accepted, internationally recognised document set suitable for regulators, customs, and import agents worldwide.
Conclusion
The UK MHRA CFS has become one of the most cost-effective and globally recognised compliance tools for medical device exporters. Its advantages — high recognition, low issuing cost, flexible documentation, predictable timelines, and regulatory stability — make it more practical than many European alternatives.
When combined with solicitor certification, Apostille, and embassy legalisation, the UK MHRA CFS provides exporters with a trusted, efficient pathway into high-barrier global markets.
Choosing the right CFS is not a procedural detail —
it is a strategic decision that directly affects speed, cost, and competitive advantage.
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