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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 […]