Several readings of medical device registration management in 2017

In March 22nd, 2017, the medical network handled a total of 6,834 items for medical device registration; handled 2,315 items for the first class of imported medical devices; registered 18,582 items for the second type of medical devices in China; and filed 13203 for the first type of medical devices in China. item.

As of the end of 2017, there are altogether medical instruments Filing certificate 41887; The second type of medical device registration card 61766; The third type of medical device registration card 20277.

In 2017, the organization formulated and issued Medical Devices standard "Administrative Measures" and other 3 related regulations for medical devices, formulating 13 regulatory documents related to medical devices such as "Regulations and Record Management Measures for Medical Device Clinical Trial Institutions," and issuing "Guiding Principles for Technical Review of Medical Device Network Security Registration" 80 related guidance documents.

In 2017, approved for intervention in artificial organisms heart Twelve domestic innovations such as valves, branch-type aortic stent grafts and delivery systems, and internationally leading innovative medical device products are on the market; Approved drug-eluting balloon catheters, Gene sequencing devices, and two priority approval products are on the market.

In 2017, the time for reviewing and approving applications for registration of third-party and imported medical device continuation registration and licensing changes was shortened by approximately 26% through the optimization of the regulatory approval process, the approval of clinical trials for the third category of high-risk medical devices, and the registration of applications for the modification of domestic third-class and imported medical devices.

In 2017, 3 batches of medical device catalogs were released for clinical trials, free from clinical trials, and medical devices expanded to 1,090 varieties.

In 2017, a group of 16 medical device classification technical committees consisting of 288 clinical, scientific research and regulatory experts was established.

In August 2017, the new “Medical Device Catalog” was released to further optimize the overall framework, reducing management categories for 40 medical devices with long time to market, high product maturity and controllable risks.

In 2017, we carried out 86 revisions of medical device standards; reviewed and approved 104 medical device industry standards and cancelled 23 items. By the end of 2017, there were 1,554 medical device standards in China, including 217 national standards and 1337 industry standards. .

In 2017, 2 batches of 19 registered applications for medical device clinical trials were conducted and random inspections. Registration applications for problems in 3 clinical trials such as cardiovascular dilatation balloon catheters were not registered and were not re-registered within one year. Acceptance decision.