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China GMP requirements are important for medical device registration in China. Key areas for China GMP requirements cover device manufacturing, product labeling, R&D design, warehousing, product packaging, etc. China’s GMP requirements are now getting closer to ISO.
In March 2022, the Chinese NMPA issued an updated rendition of GMP. This updated version reduced the time for manufacturers to get a production license, increased punishments for illegal activities, etc.
China is now doing more domestic and overseas inspections of medical device manufacturers making risky products. While overall GMP policy is under the NMPA, actual foreign inspections are done by the Center for Food and Drug Inspection, a division of the NMPA.
Pacific Bridge Medical helps device manufacturers prepare for China medical device GMP inspections. Below is a sample audit agenda.
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs.
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.