BfArM (Federal Institute for Drugs and Medical Devices)
What is BfArM?
The BfArM (Federal Institute for Drugs and Medical Devices) is a higher federal authority with headquarters in Bonn, which is assigned to the portfolio of the Federal Ministry of Health. The main tasks of the authority are the approval of finished medicinal products, the registration of herbal and homeopathic medicinal products as well as the registration of drug risks.
The central assessment and prevention of risks associated with medical products also falls within the remit of the BfArM. The legal framework is formed by, among others, the German Drug Law, the Medical Devices Law, the Narcotics Law and the Basic Substances Monitoring Law. Risks and dangers arising from the use of medical devices must be reported to the Federal Institute for Drugs and Medical Devices, which then examines the possibilities of risk avoidance in cooperation with the manufacturer.