International Approvals
International Approvals
TÜV 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 and the United States, Canada, 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 can be gained is a critical success factor in today’s competitive market environment. We enable abridged market entry for many countries through agreements with authorities and testing institutes. This means manufacturers benefit from being able to submit fewer documents and can consolidate factory inspections.
We are familiar with most international approvals, such as those relating to Japanese Pharmaceutical Affairs Law (PAL) and are a recognised Certification body for the Japanese JIS tests. Other examples of our scope include the two different schemes for approval of medical devices in China, SFDA (State Drug Administration of China) registration and CCC (China Compulsory Certification). Test results and auditing of medical devices carried out by TÜV Product Service are also recognised for achieving the registration process required in Russia (GOST certification).
For more information on our international approvals, please refer to Globalisation of Medical Device Approval.
In addition to International Approvals, TÜV Product Service provides a full range of testing, certification and training solutions with specific medical and health experience in:
| Benefits of using TÜV Product Service for international approvals |
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