Uncategorized

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), […]
January 30, 2018

China 1.2 Billion registered cell phone users: CFDA Mobile Medical Device Technical Review Guideline Announced

CFDA is regulating mobile medical devices even closer. On 29 Dec, 2017, Guideline for Technical Review of Mobile Medical Device Registration issued by CFDA, specifying the data preparing for registration […]
November 1, 2017

WuXi AppTec Launches Local Medical Device Testing Services in China

WuXi AppTec’s Laboratory Testing Division (LTD) has launched preclinical medical device testing services in China.  These services are being offered for Chinese and international clients who need to pass product […]