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China’s revised medical device GMP...

China’s National Medical Products Administration (NMPA) put...

China’s revised medical device GMP takes effect, strengthening quality and contract manufacturing requirements

China’s National Medical Products Administration (NMPA) put its revised Good Manufacturing Practice (GMP) for Medical Devices into effect on 1 November 2026. Issued under NMPA Announcement No. 107, the revised regulation replaces the 2014 edition and introduces more comprehensive requirements for quality assurance, lifecycle risk management, validation and verification, and contract manufacturing. The updated framework applies to medical device registrants, filing holders and contract manufacturers. It covers design and development, manufacturing, quality control, product release, sales and after-sales service. According to the NMPA, the revised GMP comprises 15 chapters and 132...

China’s revised medical...

China’s National Medical Products Administration (NMPA) put its revised Good Manufacturing Practice (GMP) for Medical Devices into effect on 1 November 2026. Issued under...
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