August 27, 2019

NMPA (CFDA): More Class III, Class II Medical Devices and IVDs Exempted from Clinical Trial

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
CFDA guidelines

NMPA (CFDA): MAH Available in Another 18 Provinces, Green-Lighting Contract Manufacturing

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 IVD Inspection Starts Today! 13 Requirements You Must Follow

Beijing NMPA office published Beijing IVD (In Vitro Diagnostics) Inspection Plan on August 1, specifying the requirements in upcoming inspections, from today, August 16, to October 11, for all IVD […]
August 13, 2019

NMPA (CFDA) GMP for Software: Eight Requirements You Must Follow

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

NMPA (CFDA) Roundup 201907

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 […]
August 2, 2019

24 Industry Standards in July: Time to Update Your Design Control

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 product’s design file and your […]