Zylox Medical Device Co.

2016 First China Drug Scientific Regulatory Congress

From September 20 to 21, 2016, the 2016 First China Drug Regulation Scientific Congress guided by CFDA, sponsored by China Society for Drug Regulation and undertaken by China Center for Food and Drug International Exchange, was held in Beijing, with the theme of “Reform and Innovation in Drug Regulation”.

At Medical Device Scientific Regulatory Sub-Forum, Wang Zhexiong, head of Medical Device Registration Department, CFDA, introduced the registration data of medical devices in the first half of 2016.

According to the introduction by Head Wang Zhexiong, from January to June of 2016, CFDA had approved 4346 items of medical device registration in total, among which there are 1140 items for first registration, 2487 items for continued registration and 719 items for change registration of licensing item. Moreover, CFDA rejected 298 medical device registration items. In the first half of 2016, the number of registration had obviously increased by 28.4% compared with last year and homemade in-vitro diagnostic reagents (IVDR) surged. Registration of type 3 homemade IVD was 2.5 times the number of homemade active + passive product registration. The top 5 registration amounts are from type 3 IVD enterprises. Head Wang Zhexiong also said that results of examinations and approvals of innovative medical devices had been manifested. By the end of June 2016, CFDA had received 379 applications for particular approval of innovative medical devices and decided 63 products to enter particular approval channel of innovative medical devices, 16 of which had entered into the market, e.g. Generation II DNA sequencer of companies like BGI, digital mammographic X-ray equipment of Koning (Tianjin) Medical Equipment Co., Ltd., implanted vagus nerve stimulators of Beijing PINS and drug-eluting peripheral balloon dilatation catheters of Beijing XRD Medical Technology Co., Ltd.

Kong Fanbu, director of Center for Medical Device Evaluation, CFDA said at the congress that from January to August in 2016, a total of 7088 items for medical device technologies were reviewed and assessed, and 6765 items were accepted. When pending innovative medical devices enter into a particular channel for approval, the mean acceptance time is 37 working days, saving over 60% of general product acceptance time.