October 31, 2019

UDI Rules Take Effect on Oct 1, 2019: Pay Extra Attention if You are a Manufacturer of Implants

NMPA published the final version of Unique Device Identification (UDI) Rules on August 27, 2019, with implementation date of October 1, 2019. The Rules are to adequately identify medical devices […]
October 27, 2019

Meeting on China Real World Data Pilot Program; China Med Device Participates

Leaders discussed the Real World Data (RWD) Pilot Program — a cost-effective and less time-consuming alternative to the traditional clinical trial — at a meeting in Boao, Hainan Province. China’s […]
October 21, 2019
Clinical Evaluation Report

Clinical Evaluation Report (CER) for Medical Devices in China – Areas to Look Out For

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 […]