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How to Navigate Type Testing in China

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  • Create Date April 4, 2019
  • Last Updated February 7, 2023

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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