China’s New Order 739 Includes New Device Regulations

Recently, China came out with Order 739 which has a number of new device regulations.  Some of the new regulations include – 1. the use and acceptance of different types of evidence for clinical evaluation, 2. a waiver of country-of-origin approval for Innovative products to be registered in China,  3. a shortening of the approval timeline for change notifications and renewal registrations without a technical review process,  4. an increase in the responsibilities for Market Authorization Holders (MAHs), 5. a willingness to accept more self-tests or third-party tests instead of local type testing in China, etc.

Local type testing is the first step in the China device registration process, and this could be a significant change.  However,  accepting more self-tests or third-party tests will not easily replace local China type testing since self-tests or third-party tests can only be accepted by the NMPA under very strict conditions. If a third-party testing facility is used overseas, then the third party must have the local government’s certification. If either a self-test or third-party test is used, the Product Technical requirement must still meet the China National Standards. Given the transition to this new regulation, whether self-tests will be cheaper or more efficient for foreign device manufacturers, than doing local type testing in China is still unclear.