In almost all situations for Class II and Class III devices, the NMPA will request samples for type testing. The testing centers will use the product standard to determine what tests to conduct.
- For Class II and Class III devices, NMPA will request samples for type testing. For Class I products, NMPA will accept a company’s foreign testing data.
- Testing centers will test all items listed in the Product Technical Specifications (YZB Product Standard which is drafted by the company).
- For each item, testing centers will utilize the testing method described in the Product Technical Specifications.
- While conducting the tests, the NMPA (CFDA) requests that testing centers provide comments on the company’s drafted Product Technical Specifications.
- The comments from the testing center should be submitted together with the testing report to avoid repeats and additional testing, which occurs frequently, leading to long delays in the registration process.
The testing report will be issued by a NMPA certified national testing center, which can be freely selected from the NMPA list. It is only valid for 1 year, and once it expires, a company must start again to obtain a new valid testing report.