January

January 31, 2018

China’s Grand Pharmaceutical and Canada’s Conavi Medical Align On Imaging Technology

China’s Grand  Pharmaceutical has announced that it entered into a subscription agreement with Canada’s Conavi Medical. The two companies also entered an exclusive distribution agreement for Conavi’s products. Pursuant to […]
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. […]