January 30, 2018
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
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
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
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
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
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
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
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
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
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 […]
January 17, 2018
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 […]