January

January 31, 2018

Weekly CFDA Updates(Jan 22-29, 2018)

CFDA policies, regulation updates, QA/recall/AE, and new approvals in medical device and IVD for the week of Jan 22-29, 2018:   1. Policy: CFDA announced Comprehensive Regulatory Plan for Medical […]
January 30, 2018

2018 CFDA Changes in IVD Product Classification

On December 29th 2017, CFDA issued Circular No. 226 of 2017, redefining the attributes and categories of IV diagnostic reagent products such as allergens, FACS, immunohistochemistry and in situ hybridization. […]
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 […]
January 30, 2018

China’s Orthopedic Medical Device Market Overview

OMD markets growing by 15% each year in China In China Orthopedic Medical Devices (OMD) are viewed as high value supplies with high technical content within the medical device industry. […]
January 30, 2018

Un-ignorable: China’s orthopedic implant industry

Orthopedic medical devices among largest sub-sectors in the industry Orthopedic medical devices are one of the largest sub-sectors in the medical device industry. In addition to severe external forces that […]