International Approvals for Medical Devices
International Approvals
TÜV SÜD Product Service is a International Certification Body and tests medical devices in compliance with applicable IEC standards.
Whereas individual approvals for medical devices in each country were necessary, directives now cover the EU. In addition, Mutual Recognition Agreements (MRA) exist between the EU, Australia and New Zealand enabling conformity assessment bodies to approve devices for different markets.
The speed at which approval for a new medical device for a foreign market is a critical success factor in today’s competitive market environment.
We are familiar with most international approvals, such as:
- Japanese Pharmaceutical Affairs Law (PAL)
- Japanese JIS tests
- Two different schemes for approval of medical devices in China, SFDA (State Drug Administration of China) registration and CCC (China Compulsory Certification
- Russia (GOST certification) required for the registration process
WHY CHOOSE US?
- We enable abridged market entry for many countries through agreements with authorities and testing institutes
- Manufacturers benefit from being able to submit fewer documents and can consolidate factory inspections
For more information on our international approvals, please refer to Globalisation of Medical Device Approval.
