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EUROPE

GERMANY

GERMANY

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Global   >   Europe    
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.

Market Info

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

Med Dev Regulation
Classification, Fees, Timeline
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Fees
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. 

Registration Routes
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

Useful Info

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