Category: NMPA (CFDA) Updates

The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is

NMPA (CFDA) issued the First Group of Unique Device Identification Devices (Draft) for feedback on September 17, and specified the medical devices going into UDI

NMPA (CFDA) published the “Guideline on Raw Material Change Evaluation of Non-active Device (Draft)” on June 27. Discussing design control, change control, Basic Safety and

NMPA News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. Keep yourself updated with NMPA

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

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

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