China's State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for these devices. All of these regulations have been marked as interim and could be subject to change. SFDA also issued notices on standardizing the production quality management systems and the supervision and inspection of these devices.
For non-sterile/implantable medical devices, SFDA has formulated Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim). These regulations will standardize quality management systems, intensify supervision on manufacturing, and strengthen the management of medical device GMP inspection.
The Good Manufacturing Practice for Medical Devices (interim) contains 13 chapters and 69 articles. The 13 chapters cover management responsibilities, file and record requirements, design and development, manufacturing management, inspections, sales and services, adverse events, and so forth. Manufacturers must demonstrate that they have appropriate documentation and SOPs in place for quality control and after-sales service.
GMP compliance would be required for Class II and Class III devices. In addition, manufacturers will be subject to an on-site GMP audit if they are applying for the first time or reregistering.
The SFDA first started discussions on medical device GMP certification in 2004. The first GMP rules were set up in 2005 with a trial period to determine feasibility.
These new GMP regulations for both regular and sterile/non-implantable medical devices will probably be revised and become effective in January 2011.
Ames Gross, president and founder of Pacific Bridge Medical (PBM), is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, MD&DI (Medical Device and Diagnostic Industry) magazine named Gross one of the top 100 executives in the medical business. Gross founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He is a frequent contributor of articles on Asian medical issues for Clinica (UK), MD&DI (Los Angeles), and other medically oriented journals. Gross has been a featured speaker on the Asian medical markets at the Medical Design & Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society's annual and regional meetings, and a variety of other medically oriented meetings and conferences. Gross holds a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. For more information about PBM, view its listing in the online Consultants Directory or go to the firm’s Web site at www.pacificbridgemedical.com.