Year: 2019

After the U.S. announced the tariff plan of $300 billion Chinese exports, China released the newest tariff list on $75 billion of U.S. exported goods on Aug 23. Amid the

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

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,

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.

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

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

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), Class I (53 items) and

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 “adequately identify medical devices through

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 1, 2019. When registering imported

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 China Med Device, were interviewed