November 13, 2019

NMPA (CFDA) News Roundup 201910

The 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 China Med Device, LLC […]
November 11, 2019

AdvaMed Webinar: Latest Developments in Clinical Pathways for NMPA (CFDA) Submission

Time: Tuesday, November 12, 2019 | 11:00 am – 12:00 pm ET Presented by China Med Device, LLC Register Here This webinar will cover different clinical pathways and how to […]
November 6, 2019
NMPA Regulations

China Medical Device Regulations – An Overview

China National Medical Products Administration regulates medical devices and pharmaceutical products across China. The NMPA was also known as China Food and Drug Administration in the past. For medical device […]
November 3, 2019

In One Day, 28 Class II Device Guidelines Released by NMPA

NMPA issued 28 draft guidelines on October 18 for feedback. The guidelines cover one class III device, 27 class II devices and IVDs (cardiovascular, gastroenterological, urological, dental, gynecological and pediatric […]
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 […]