Blogs

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 […]
January 29, 2018

Highlights of CFDA’s Newly Released “Medical Device Clinical Trial Design Guidelines”

On January 8th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this document.   In this guidelines […]
January 29, 2018

CFDA Must Read—— New Guideline for Medical Device Oversea Inspection

The CFDA is putting greater emphasis on the quality system management and post-market compliance of overseas medical device manufacturers. In the past, very rarely did the national CFDA make public […]