Using a Certificate of Free Sale (CFS) to Grow Internationally
Legal background
Several non-EU and non-UK markets ask for a Certificate of Free Sale, including Brazil, India, Saudi Arabia, Egypt, and Thailand, where a CFS is commonly needed to permit the import and sale of medical devices. This makes it a key document for both regulatory submissions and customs procedures.
How a Certificate of Free Sale Supports Global Market Access
Why manufacturers obtain a UK-issued CFS
International market access
Supports the export of medical devices to markets outside the UK and EU.
Proof of UK compliance
Provides official evidence that your device complies with UK MDR requirements.
Greater credibility
Builds confidence among distributors, business partners, and overseas authorities.
Simplified regulatory submissions
Helps meet documentation requirements for international registrations and customs procedures.
Our services
How to Obtain a Certificate of Free Sale in the UK
Whether acting as your UK Responsible Person or wider regulatory partner, Obelis manages the CFS application from beginning to end. We confirm your product’s alignment with UK MDR, ensure accurate MHRA registration, and compile the documentation needed to submit a compliant CFS application on your behalf.
Regardless of whether you’re a UK manufacturer or an overseas company working through a UK Responsible Person, we communicate directly with the MHRA, track your application’s progress, and secure the official CFS so your devices can reach global markets without unnecessary delay. Working with Obelis UK means lower risk, fewer regulatory obstacles, and faster access to new markets.
1
Step 1
Verify Compliance
We confirm your medical device complies with UK MDR requirements and is eligible for a Certificate of Free Sale (CFS).
2
Step 2
Prepare Your Application
We review your documentation and compile a complete CFS application for submission.
3
Step 3
Apply to the MHRA
We communicate directly with the MHRA and manage the application process on your behalf.
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Step 4
Receive Your CFS
We secure your Certificate of Free Sale, helping you access international markets with confidence.
Related Services
Compliance for Medical Devices in the United Kingdom
Frequently Asked Questions
A Certificate of Free Sale (CFS) is an official document issued by the Medicines and Healthcare products Regulatory Agency (MHRA) confirming that a medical device complies with UK MDR requirements and is lawfully marketed in Great Britain. Many countries use the CFS as evidence that a device meets recognised safety and regulatory standards.
Many countries outside the UK and EU, including Brazil, India, Saudi Arabia, Egypt, and Thailand, commonly request a Certificate of Free Sale (CFS) when importing medical devices. The CFS is often required for regulatory submissions, product registration, and customs clearance before devices can be placed on these markets.
Both UK manufacturers and overseas manufacturers can obtain a Certificate of Free Sale (CFS). Non-UK manufacturers typically apply through their appointed UK Responsible Person (UK RP), who manages communication with the MHRA, prepares the required documentation, and submits the application on the manufacturer’s behalf.
To obtain a Certificate of Free Sale (CFS), manufacturers must first ensure their medical devices comply with UK MDR requirements and are correctly registered with the MHRA. At Obelis UK Ltd., an experienced UK Responsible Person can manage the entire process, including reviewing documentation, submitting the application, communicating with the MHRA, and obtaining the official certificate to support international market access.