Uncategorized

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 […]
May 31, 2019

2019 National Quality Inspection Plan Just Released: Pay Attention to Your Device Standards

NMPA (CFDA) announced “2019 National Quality Inspection Plan for Medical Devices”. The Plan asks provincial NMPA offices and type testing centers to conduct quality inspections based on Industry Standards and […]
May 22, 2019

New E-filing Requirement Posed for Legal Agent in China

NMPA issued “Notice on the Application of Certificate Authority (CA) certificate for Medical Device Registration Service Platform (eRPS)” on May 7, which introduced the Certificate Authority (CA) to all the […]
April 22, 2019

Common Errors in Writing NMPA IVD Clinical Protocol

Clinical trial protocol is a vital component in IVD clinical design and, in China, the details of the protocol never fail to be questioned by NMPA (CFDA) reviewers.  ChinaMed Device, […]
March 20, 2019

CFDA News Roundup 201902

Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), […]