Highlights of CFDA 2016 Medical Device Registration Annual Report (Part 4 of 4)

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The Review and Approval of Innovative Medical Devices

In 2016, China Food and Drug Administration received a total of 197  applications for  approval of innovative medical devices, organized expert to review 175  of them, completed the review of 144 (including applications in 2015), and 45 products among them were allowed to enter the special approval channels for innovative medical devices. 10 products were approved to enter the market. Among them, there were 6 active medical devices, 3 passive medical devices, 1 in vitro diagnostic reagents. Compared with 2015, the total number increased by 1.

The core technology of these innovative products have owned China’s invention patent or the invention patent application has been disclosed by the patent administrative departments of State Council, and the main working principle / mechanism of the core technology are initiative in China, with significant clinical application value.

This report is provided by China Med Device, LLC. Please stay tuned for the last part of this CFDA annual report.


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.

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