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Certificate of Free Sale (CFS)

A Certificate of Free Sale (CFS) is an official document that confirms a medical device complies with UK regulatory requirements and is legally marketed in Great Britain. It enables manufacturers to demonstrate that their products meet high safety and quality standards, helping them gain access to international markets outside the United Kingdom. The CFS is issued by the MHRA (Medicines and Healthcare products Regulatory Agency) to eligible applicants.

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Expand Internationally with a Certificate of Free Sales (CFS)

Legal background

What countries require a Certificate of Free Sale? The answer includes a wide range of non-EU and non-UK territories—such as Brazil, India, Saudi Arabia, Egypt, and Thailand. These countries often request a CFS to authorise the import and sale of medical devices, making it an essential document for regulatory submissions and customs clearance. If you want to expand your business beyond the UK, the CFS is an essential tool. Many non-EU countries accept the UK CFS as evidence that the device complies with stringent safety and regulatory standards, simplifying the export process.

Benefits of obtaining a CFS include:
    • Facilitates market entry into third countries.
    • Provides official proof of compliance with the UK MDR.
    • Strengthens your reputation with international stakeholders.
    • Helps meet documentation requirements for foreign regulators.
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How to get a Certificate of Free Dale in the UK? 

As your UK Responsible Person or regulatory partner, Obelis simplifies the CFS application process from start to finish. We verify your product’s compliance with UK MDR, ensure your registration with the MHRA is accurate, and gather all necessary documentation to submit a compliant CFS request on your behalf. Whether you’re a UK-based manufacturer or a non-UK entity working through a UK Responsible Person, we liaise with the MHRA, monitor application status, and deliver the official CFS so your devices can be exported globally without delay. With Obelis, you reduce risk, avoid regulatory pitfalls, and gain access to new markets faster.

Apply for your CFS today
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