October 8, 2019

Two Milestones at IMDRF Meeting: Bringing China Closer to International PMS and Clinical Standards

International Medical Device Regulators Forum (IMDRF) Committee Members meeting was held on September 17-19, in which China NMPA achieved two milestones. The commitments, on post-market-surveillance (PMS) and clinical evaluation, will […]
September 25, 2019

NMPA – First Group of UDI Devices Released: 64 Devices as First Trial

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 implementation. Devices Impacted In early […]
September 17, 2019

NMPA Guideline on Raw Material Change: 11 Devices as Example

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 Effectiveness List, evaluation pathways, implications […]
September 13, 2019

AdvaMed VIP Social: you’re invited!

Please join us on Tuesday evening during the AdvaMed MedTech annual conference for an extraordinary networking social. AdvaMed Networking Meet top China government officials and hospital CEOs, AdvaMed leaders and […]
September 10, 2019

NMPA News Roundup 201908

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 News Roundup, click HERE to […]