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 Chinese 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.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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