Blog

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 […]
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 […]
January 26, 2018

Key Aspects to Expedite Your Medical Device’s Approval with CFDA

After a major overhaul in 2014, the CFDA “Regulations on the Supervision and Administration of Medical Devices” have been focusing on registration quality management system verification with higher requirements, compared […]
January 26, 2018

Weekly CFDA Updates (Jan 14-20)

China Med Device publishes weekly CFDA updates covering medical device regulation, guideline, standard, recall, adverse event alert, recall, registration approval. Below are the CFDA updates from January 14 to January […]
January 24, 2018

CDFA Released Technical Guidelines for The Registration of Animal-Derived Medical Devices

On January 5th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this document.   This guideline is […]
January 23, 2018

2018 China Medical Device Market Outlook

China’s medical device industry has been experiencing rapid development. It has completed the original technology and capital accumulation, and the initial adjustment of product structure and regional industrial layout. After […]
January 22, 2018

New Landscape of Medical Device Clinical Trial— CFDA’s Requirements for Accepting International Clinical Data

On January 11, 2018, the CFDA issued a guideline for accepting medical device international clinical trial data. This new guideline could benefit foreign medical device manufacturers by facilitating their clinical […]
January 19, 2018

French Telecare Solution for Seniors To Be Deployed in China

According to news reports, on January 9th, during an official business session in front of both the French President Emmanuel Macron and Chinese President Xi Jinping in Beijing, Senioradom, a […]