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China’s revised medical device GMP...

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

Council of Europe proposes regulatory...

The European Committee on Organs, Tissues and...

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...

Council of Europe...

The European Committee on Organs, Tissues and Cells (CD-P-TO) of the Council of Europe, with Secretariat support from the European Directorate for the Quality...

PIC/S updates qualification...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has revised its Recommendations on Qualification and Validation, issuing document PI 006-4. The updated recommendations entered into force...

Thermo Fisher Scientific...

Thermo Fisher Scientific announced on 18 January 2024 that its manufacturing facility in Monza, Italy, had received Good Manufacturing Practice (GMP) approval from the...
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