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2026 China NMPA Bluebook is here:
NMPA published “Extension of Pilot Program for Market Authorization Holder (MAH) system” on August 1, introducing the MAH system for 18 provinces including the booming
Beijing NMPA office published Beijing In Vitro Diagnostics Inspection Plan on August 1, specifying the requirements in upcoming inspections, from today, August 16, to October
NMPA (CFDA) published Good Manufacturing Practice Annex on Standalone Software on July 12. After satisfying Good Manufacturing Practice on Medical Devices, software manufacturers have to
The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recalls/AEs, and new approvals in medical devices and IVDs in China. It is
NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30. If these standards are applicable to your device, please check your
NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30. If these standards are applicable to your device, please check your
NMPA (CFDA) published the First Batch of Medical Device Classification Results on July 18. This document, classifying Class III (56 items), Class II (78 items),
NMPA (CFDA) and National Health Commission announced the “Unique Device Identification (UDI) System Implementation Plan” on July 7. The UDI system has been established to
NMPA (CFDA) issued “Notice on Requirements for Medical Device Electronic Submission” on July 10. It lists three requirements which are to be implemented on August
NMPA published Technical Guideline on AI-Aided Devices on June 28, 2019. Grace Fu Palma, CEO of China Med Device, and Zhiyong Rao, Testing Director of
The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recalls/AEs, and new approvals in medical devices and IVDs in China. It is
Q: What regulations are applicable for advertising medical devices in China? A: The current applicable regulations include: Methods of Medical Device Advertisement Reviewing (NMPA NO.