4 matches for the tag »BfArM«

Clinical Studies

The Law and Clinical Trials In accordance with Section 20 sub-section 1 of the German Act on Medical Devices (“Medizinproduktegesetz”, … read more »

URL https://mapmedtech.com/germany/product-licensing/clinical-studies-in-germany/

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First Placing

What is the definition of First Placing? In the German version of Directives 90/385/EEC, 93/42/EEC and 98/79/EC, “Inverkehrbringen” is defined … read more »

URL https://mapmedtech.com/germany/reimbursement/first-placing-in-germany/

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Decision Makers

The German Institute for Medical Documentation and Information (DIMDI) The German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und … read more »

URL https://mapmedtech.com/germany/decision-makers-in-germany/

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The Federal Institute for Drugs and Medical Devices (BfArM)

Medical Devices and BfArM Incident Reports The tasks of BfArM with regards to medical devices focus particularly on the evaluation … read more »

URL https://mapmedtech.com/germany/decision-makers-in-germany/the-federal-institute-for-drugs-and-medical-devices-bfarm/

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Tag Cloud

Authorised Representative BfArM CE Mark Classification Clinical Studies Code of Conduct Competent Authority Diagnostic DIMDI Ethics Europe Executive Federal Law First Placing G-BA Germany Government Government Affairs InEK In Patient In vitro IQWiG Law Legislative Lobbying Manufacturer Market Medical Apps MPG NUB Out Patient PKV Private Health Insurance Public Affairs Public Relations Register Reimbursement Risk Serious Adverse Events Software The Bundesrat The Bundestag The Federal Institute for Drugs and Medical Devices The Federal Joint Committee The Institute for Quality and Efficiency in Healthcare