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 […]
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