August 27, 2019
NMPA (CFDA) published “Clinical Trial Exemptions Catalog for Medical Devices (Draft)” on August 1, 2019. It is an effort to implement risk-based clinical evaluation, and to make medical device clinical […]
August 20, 2019
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 med-tech markets of Beijing, Zhejiang, […]
August 16, 2019
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 11, for all IVD manufacturers. […]
August 13, 2019
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 meet the eight special requirements […]
August 6, 2019
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 edited by ChinaMed Device, LLC […]