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 […]
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. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
This guideline is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. This document does not fully cover the clinical evaluation data that may […]