Market Information
Germany’s healthcare expenditure has increased significantly over the years, with spendings of approximately $8011 per capita on health in 2023, more than the OECD (Organisation for Economic Co-operation and Development) average of $4986 (USD PPP). The Germany-connected healthcare market is projected to grow from $2.43 Bn in 2022 to $16.03 Bn by 2030, registering a CAGR of 26.6% during the forecast period of 2022 - 2030.
Market Trend: In Germany, health insurance is required. The percentage of people enrolled in statutory health insurance, which covers inpatient, outpatient, mental health, and prescription medication coverage, is about 86%.
Germany’s medical equipment market accounts for roughly USD 42 billion annually, or 25 percent of the European market total.
Medical Device Regulation
The Federal Institute for Drugs and Medical Devices (BfArM).
https://www.bfarm.de/EN/Medical-devices/Overview/Laws-and-ordinances/_node.html
Classification, Fees, Timeline
Product Registration Routes
Class I
Class IIa, IIb, III, AIMDs
All Medical Devices need to bear the CE marking in order to be marketed in Germany.
Useful Information
Validity of License: 5 years
License transfer: Change of Registration application needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
Quality System: ISO 13485:2016
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