As UKCA Free Sale Certificate consultants, we assist companies in obtaining documentation to demonstrate compliance with UK regulations. Our expert team navigates the intricate process, ensuring your products meet all necessary standards. We handle the entire certification process, from assessment to documentation, ensuring smooth market access. With our guidance, you can confidently demonstrate compliance with UKCA requirements, facilitating sales and distribution in the UK market. Trust our consultancy services to streamline the certification process, saving you time and effort while ensuring regulatory compliance.
Free Sale Certificate Services
- It is a legal document that shows that the medical device is approved for Sale in Europe.
- Provided by the Competent Authority of the European Union and confirms that the medical devices sold by the manufacturer are CE-marked and can be sold in the European Market.
- The European Free Sale Certificate is used by manufacturers to speed up their Entry Procedures in non-EU markets.
Who Requires Free Sale Certificate?
Non-EU manufacturers of MDR and IVD Medical devices can request a Free Sale Certificate through an authorized representative (like CERT-3) To Apply for a European Free Sale Certificate and initiate the process, choose the desired service and fill out the form.
Who can Issue a Free Sale Certificate?
Any European country can issue the FSC upon the request by an Authorized representative acting on behalf of a foreign medical device manufacturer. If your company is from a non-European country and cannot communicate directly with the Competent Authority, we can serve as your European Authorized Representative. To obtain the FSC from a European Authority, the following Documentation is required:
EU Registration Details
- CE Certificate(s)
- EU Declaration of Conformity, signed, dated, and stamped
- EU Representative designation letter
The FSC can be legalized by the Chamber of Commerce, the Ministry of Foreign Affairs, and the relevant Embassy in EU countries. Learn more about the EU Registration (EUDAMED) process by visiting our website. If your medical device is not manufactured in Europe, only an Authorized Representative can obtain the FSC on behalf of the manufacturer.
The process for obtaining the FSC is as follows:
- Prepare the Technical File.
- Apply for NB CE Certification or prepare DOC for Class I devices.
- Appoint a European Authorized Representative.
- Register the Medical Devices with the EU.
- Apply for the FSC with the medical device authority where the European Authorized Representative is located.
The timeline for issuing the European Free Sale Certificate is as follows:
- Drafting and mutual signing of the EAR Agreement: 1 week
- EU Registration: 1 week
- FSC Application with Competent Authority: 2-3 weeks
- Issuance of FSC and attestation: 1 week
- Embassy attestation (if required): 1 month (duration varies by country)
We offer fast and cost-effective services for non-European medical device manufacturers and exporters.
- EU Device Registration: 500 Euros per devices
- FSC Application and Follow-up: 4500 Euros for up to 2 devices
- FSC Attestation: 350 Euros per UMDNS Code
- Embassy attestation: Please contact us for further information.