Basic information on getting started in the medical device field and launching medical devices is explained at Basic information.

The monitoring of the manufacture, placing on the market and circulation of medical devices (including their operation and use) and the related implementation of the acts and ordinances is the exclusive responsibility of the federal state authorities in Germany (Landesbehörden). We would therefore ask you to contact the state authority responsible for you. This would be the state authority where your company or distributor is located.

Under the following link you can find out the competent federal state authority yourself:

Competent authorities and ethics committees

If you have a CE mark for your medical product that is valid for the European market, you can also market the product in Germany.

More information:

FAQ: Do distributors or importers have to notify the distribution of medical devices that are already registered in the European Economic Area in Germany?

Many countries, such as Colombia or Pakistan, allow the marketing of products that have already been approved for the European market. Therefore, manufacturers must be able to prove that their products can be legally marketed there. These confirmations are called "free sale certificate (FSC)", "Freihandelszertifikat", "Verkehrsfähigkeitsbescheinigung" or "Exportbescheinigung", depending on the authority.

The BfArM does not issue export certificates. The competent authority issues a certificate of marketability of the medical device in Germany for export upon application of a manufacturer or authorised representative. We therefore ask you to contact your competent supervisory authority with your request.

Competent authorities and ethics committees

Unfortunately, this is not possible for us, as standards are subject to copyright protection and may not be reproduced. An overview of standards and procurement options can be found at Beuth-Verlag.

Questions on the eligibility for reimbursement of medical devices are not within the scope of responsibility of the BfArM. We therefore ask you to contact the Kassenärztliche Vereinigung in your federal state.