Free Sale Certificate for Medical Devices

A Free Sale Certificate (FSC) for medical devices is an official regulatory document confirming that your medical device is legally marketed and freely sold in the issuing country without restriction. It is one of the most critical documents required for exporting medical devices to international markets across Asia, the Middle East, Latin America, and beyond.

I3CGlobal provides EU Free Sale Certificate, UK Free Sale Certificate, and full global attestation services for non-European and non-UK medical device manufacturers — fast, reliably, and at transparent pricing.

A Free Sale Certificate (FSC) also called a Certificate of Free Sale (CFS) is evidence that a medical device can be legally sold or distributed freely in the country of origin without restriction, as approved by the relevant regulatory authority. Importing countries often require this document as part of their product registration or market entry process.

The Free Sale Certificate for medical devices is issued by the Competent Authority of the country in which the device is registered. For non-European manufacturers, this means obtaining an EU Free Sale Certificate through a EU Authorized Representative (EU REP), or a UK Free Sale Certificate through a UK Responsible Person (UKRP).

I3CGlobal acts as your EU REP and UKRP, enabling us to apply for and issue your FSC directly — making the process seamless, fast, and cost-effective.

Medical device manufacturers and exporters from the following regions commonly require a Free Sale Certificate to access global markets:

• Manufacturers in India, China, South Korea, Japan, Malaysia, Vietnam, and Southeast Asia exporting to regulated markets
• US-based manufacturers exporting to countries that require EU or UK regulatory proof
• Middle Eastern and Latin American manufacturers targeting EU, UK, or Asian markets
• Any non-EU or non-UK manufacturer registering devices in countries that require proof of market authorization from a reference country

Countries that commonly require an FSC for medical device import registration include: Saudi Arabia, UAE, Egypt, Indonesia, Philippines, Thailand, Brazil, Mexico, Colombia, Russia, India, Pakistan, Bangladesh, Sri Lanka, and many more.

The EU Free Sale Certificate confirms that your medical device complies with European Union Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746) and is legally placed on the EU market. It is issued by a Competent Authority of an EU Member State — typically the country where the EU Authorized Representative is based.

Since non-EU manufacturers cannot directly communicate with EU Competent Authorities, the EU Authorized Representative (EU REP) must apply for the FSC on the manufacturer’s behalf. I3CGlobal is a licensed EU REP registered in multiple EU Member States, enabling us to issue EU FSCs from accepted reference countries including Spain, Netherlands, Portugal, and Ireland.

• EU EUDAMED Registration details
• CE Certificate(s) issued by a Notified Body (for Class IIa, IIb, III devices)
• EU Declaration of Conformity (DoC) — duly signed, dated, and stamped
• EU Representative Designation Letter

• Prepare the Technical Documentation / Technical File
• Apply for Notified Body CE Certification (Class IIa/IIb/III) or prepare Declaration of Conformity (Class I devices)
• Appoint I3CGlobal as your European Authorized Representative (EU REP)
• Complete EU EUDAMED Registration of the medical devices
• Submit FSC application to the Competent Authority in the EU REP’s country
• Receive the EU FSC and proceed to legalization / embassy attestation if required

The Chamber of Commerce, the Ministry of Foreign Affairs, and the relevant Embassy are the three institutions in EU countries that can legalize and attest the FSC. This is often required by importing countries such as Saudi Arabia, UAE, and Gulf nations.

Following Brexit, the United Kingdom operates a separate regulatory framework under UKCA (UK Conformity Assessment) regulations. A UK Free Sale Certificate certifies that your medical device is legally marketed in the United Kingdom and can be freely exported. The UK is widely recognized as a reference country for FSC purposes, and a UK FSC is specifically required by many importing countries.

For non-UK manufacturers, a UK FSC can only be obtained through a licensed UK Responsible Person (UKRP)registered with the MHRA (Medicines and Healthcare products Regulatory Agency). i3CGlobal is an MHRA-registered UKRP, fully authorized to obtain and issue UK Free Sale Certificates on behalf of foreign medical device manufacturers.

• MHRA UK Registration details
• UKCA Certificate or Declaration of Conformity
• UK Responsible Person Designation Letter
• Product listing confirmation from MHRA database

Following Brexit, the United Kingdom operates a separate regulatory framework under UKCA (UK Conformity Assessment) regulations. A UK Free Sale Certificate certifies that your medical device is legally marketed in the United Kingdom and can be freely exported. The UK is widely recognized as a reference country for FSC purposes, and a UK FSC is specifically required by many importing countries.

For non-UK manufacturers, a UK FSC can only be obtained through a licensed UK Responsible Person (UKRP)registered with the MHRA (Medicines and Healthcare products Regulatory Agency). I3CGlobal is an MHRA-registered UKRP, fully authorized to obtain and issue UK Free Sale Certificates on behalf of foreign medical device manufacturers.

For manufacturers located outside the EU or UK who comply with the applicable regulations, the typical timeline for obtaining a Free Sale Certificate is as follows:

• EAR/UKRP Agreement Drafting & Signing : 1 Week
• EU/UK Device Registration : 2 Weeks
• FSC Application with Competent Authority : 3 Weeks
• Issue of FSC & Initial Attestation : 1 Week
• Embassy Attestation (if required): 1 Week

Total estimated time: 5–8 weeks (without embassy attestation) or 8–12 weeks (with embassy attestation, depending on the importing country’s embassy schedule).

I3CGlobal offers fast, transparent, and cost-effective Free Sale Certificate services for medical device manufacturers and exporters worldwide. Our pricing is straightforward with no hidden fees.

I3CGlobal is a globally recognized medical device regulatory consultancy with offices in the United States, United Kingdom, Germany, Portugal, India, Malaysia, South Korea, Thailand, Vietnam, Turkey, and Australia. Our team of regulatory experts has helped hundreds of medical device manufacturers successfully enter new markets through our FSC services.

• Authorized EU REP & UKRP — We are officially registered and authorized to issue both EU FSC and UK FSC.
• Multiple Reference Countries — We can issue FSCs from EU member states with the highest global acceptance rates.
• End-to-End Service — From EU/UK registration to FSC application, attestation, and embassy legalization — all under one roof.
• Transparent Pricing — No hidden fees. Fixed pricing for most services with clear timelines.
• Fast Turnaround — Our streamlined process ensures minimal delays with regular follow-ups with Competent Authorities.
• Global Reach — Serving manufacturers across India, China, USA, South Korea, Japan, Middle East, Southeast Asia, Latin America, and Africa.

The EU Free Sale Certificate and UK Free Sale Certificate issued by I3CGlobal are accepted in a wide range of importing countries. Below is a partial list of countries that commonly require a Free Sale Certificate for medical device registration:

• Middle East & Africa: Saudi Arabia, UAE, Qatar, Bahrain, Kuwait, Oman, Egypt, Jordan, Iraq, Pakistan, Ethiopia, Kenya, Nigeria
• Asia Pacific: India, Indonesia, Philippines, Thailand, Vietnam, Malaysia, Bangladesh, Sri Lanka, Myanmar, Cambodia
• Latin America: Brazil, Mexico, Colombia, Peru, Chile, Argentina, Ecuador
• Others: Russia, Kazakhstan, Ukraine, Morocco, Algeria, Tunisia

Note: Acceptance criteria vary by country. Our regulatory experts will advise you on which FSC (EU or UK) is most appropriate for your target market. [Contact us for country-specific guidance.