The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) is the medical device regulatory authority in Germany. Functioning as an independent body within the Federal Ministry of Health, the BfArM deals with the authorization of drugs of medical devices on the basis of the German Medicines Act (Arzneimittelgesetz, AMG), monitors legal trade of narcotics, and evaluates the potential risk posed by medical devices.

The BfArM is divided into 9 departments, the 9th department being exclusively dedicated to medical device oversight. Its main focus is the evaluation of incident reports and the authorization of clinical investigations on medical devices.

A list of EU regulations can be found here on our website

Contact details:

• Website: http://www.bfarm.de/EN/Home/home_node.html

Medical Device Associations in Germany:

• Bundesverband Medizintechnologie (BVMed)
• Bundeszahnarztekammer Arbeitsgemeinschaft der Deutschen Zahnarztekammern eV
• Deutsche Gesellschaft für Telemedizin
• Deutsche Krankenhausgesellschaft
• Fachverband Biomedizinische Technik e.V.
• Kassenärztliche Bundesvereinigung (KBV)
• Spectaris eV
• VDGH Verband der Diagnostica-Industrie eV
• Zentralvereinigung medizin-technischer Fachhändler, Hersteller, Dienstleister und Berater e.V.
• Zentralverband Elektrotechnik- und Elektronikindustrie e.V. (ZVEI)