Device Manufacturers in China Face Increased Regulatory Scrutiny

China’s State Food and Drug Administration (SFDA) continues to ramp up plans to improve quality and increase regulations in the medical device arena. After setting up a trial Good Manufacturing Practice (GMP) scheme for sterile and implantable medical devices, SFDA issued the Regulations for Medical Device Manufacturing and Quality Control and Inspection Methods to Regulations for Medical Device Manufacturing and Quality Control to solicit public comments in 2008.

The draft GMP regulations propose on-site inspections for companies registering for the first time or re-registering a medical device. In addition, if there are changes to the China medical device manufacturing license, the manufacturing site, or the manufacturing scope, SFDA would conduct an on-site audit. Medical companies would submit documents such as their business license, medical device manufacturing license, corporate organizational chart, and so forth to SFDA for review. Following that, GMP inspectors would audit the facility and SFDA would then review the audit report.

These GMP regulations probably will be revised and become mandatory in 2010 or 2011. As of now, there is no official announcement on a clear target date.

SFDA has also revised the Provisions on Medical Device Registration this year. Compared with the current provisions, the revised provisions emphasize legal responsibilities and intensify punishment of illegal activities. SFDA will reject registration from China medical device manufacturing applicants who provide false application materials such as fake certificates, documents, and product samples and punish them with a fine.

Applicants are required to conduct research on devices by performing a relevant risk analysis and verify device safety, effectiveness and quality control. They will also need to submit reports on the technical functionality and performance of the device and risk management processes, as well as a self-assessment on the quality management system.