October 18, 2019
2019 China Medical Device Outlook

2019 China Medical Device Market Outlook

Last year, we published our 2018 China medical device market outlook. It is time for us to give our 2019 outlook in this post. Overall Health Expenditure in China Continuing […]
October 15, 2019

NMPA (CFDA) News Roundup 201909

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 edited by ChinaMed Device, LLC […]
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 […]