The CFDA Medical Device Registration and Review Report for June 2017

Share:

CFDA Application Acceptance

According to Insight-China Pharma Data, a total of 304 medical devices registration were accepted in June 2017 (counted by numbers of acceptance), which stayed at the lowest level in the first half of 2017, and were less than the number 870 in the same period last year.

The acceptance number of medical device applied in June included a total of 102 domestic devices, 30 domestic reagents, 158 imported devices, and 14 imported reagents according to the type of application.

The total acceptance number applied showed that there were 9 enterprises which had submitted more than 4 device registration applications in June 2017.

According to the contents of the device registration application, there were 50 products registration applications, 177 renewal applications application, and 77 licensing items changing application in total.

CFDA Review and Approval

In June 2017, a total of 1515 device registration review were completed. Compared with the number 1012 last month, there was an approximate increasing of 50%. There was also a slight increasing on year-on-year basis.

Most of the medical device application reviews completed in June were renewal application and licensing items changing application, the total number of completed product registration approval were 176, and designated inspection registration were 58.

Special instruction: The designated medical device registration inspection refers to the behavior that the products waiting for inspection which were out of the inspection scope of any qualified medical device inspection agency were inspected by medical device inspection institution designated by corresponding food and drug supervision and management departments based on the applicant’s registration inspection application when the medical device product registration inspections were carried out.

According to the type of application, the review of a total of 380 domestic devices and 647 imported devices were completed this month. Detail proportion was shown as follows:

According to statistics of Insight database, there are a total of 15 enterprises which the number of medical devices reviews completed were more than 10 this month.

 


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.

Related Posts