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How to Navigate Type Testing in China

China FDA (NMPA) requires local type testing for the market approval of Class II and Class III medical device/IVD products. China local type testing is a mandatory step for registration and must be completed before the initiation of local clinical studies if needed.

Before starting a local type testing in China, you must be ready to answer questions such as:

• What tests need to be done in China?
• Which testing center should I use?
• What Chinese technical standards apply to my products?
• When is the best time to plan for the tests?
• How to write a Product Technical Requirement (PTR)?
• Do certain tests in China need to be repeated?
• Do we need type testing for renewal submissions?

Get answers to these questions and more during this informative webinar!

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