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!