.png)
市场信息
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.
医疗器械监管
The Federal Institute for Drugs and Medical Devices (BfArM).
https://www.bfarm.de/EN/Medical-devices/Overview/Laws-and-ordinances/_node.html
分类、费用、时间表
产品注册途径
Class I
Class IIa, IIb, III, AIMDs
All Medical Devices need to bear the CE marking in order to be marketed in Germany.
有用信息
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
Benötigen Sie weitere Details?
Wir sind hier, um zu helfen. Kontaktieren Sie uns auf der ATTOPOLIS-Plattform.
