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2026 China NMPA Bluebook is here:
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
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
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
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
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
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
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
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
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
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
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
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