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!