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European Free Sale Certificate for Medical Devices – EU FSC

Your customer or registration authorities often ask for a Free Sales certificate issued from a European country; below are details of the European Free Sales Certificate.

The European Free Sale Certificate (FSC) allows medical devices to be legally sold or distributed freely without restriction with the approval of the regulatory authority of that country.

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The Competent Authority from European countries issues it upon request by the manufacturer’s Authorized Representative on behalf of the medical device manufacturer.

If you are a manufacturer outside the EU, we can act as your European Authorized Representative.

For the issuance of FSC by a European Authority, the following documentation is required:

  • CE Certificate(s) issued by authorized Notified body
  • EU Declaration of Conformity
  • Product list for which Free Sales Certificate is required

In some cases legalization of FSC is required, which can be taken up by either of the below authorities:

The Chamber of Commerce, The Ministry of Foreign Affairs, and the relevant Embassy.

The usual timeline for issuing a Free Sales Certificate is around 4-6 weeks.

Contact us for more details on EU FSC.

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