China: Updated Medical Device Manufacturing Regulations

Starting May 1, the China National Supervision Administration updated the 2014 Measures on the Supervision and Administration of Medical Devices Manufacturing. These measures put in effect more rigorous regulatory manufacturing requirements and increased the responsibilities of medical device manufacturers and third-party OEMs. While these measures have many updates, several new rules include – enhanced measures for product release, applicants for medical device manufacturing licenses need to include all the medical devices they plan to make, and authorities doing on-site audits can also review individuals or other areas that provide services or products to the device manufacturer. The measures also detail more information on inspections and outline penalties for non-performance.

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.