12 innovative medical devices accelerated approval for listing

In recent years, China's policy of encouraging medical device innovation has been continuously introduced, which has played a huge role in promoting industrial innovation.

According to the data, in 2017, the National Food and Drug Regulatory Agency continued to perform innovative medical device review work in accordance with the "Special Approval Procedure for Innovative Medical Devices (Trial)", and received 273 applications for approval of innovative medical devices in the year, completing 323 reviews. (Including 2016 application items), 63 products were approved to enter the special approval channel for innovative medical devices, and 12 innovative products such as registered branch-type aortic stent grafts and delivery systems were approved for launch. Among them, there were 4 active medical devices and 8 passive medical devices, which increased by 2 compared with the same period of last year.

The core technologies of these innovative products all have patents for inventions or applications for invention patents that have been disclosed by the Patent Administration Department of the State Council. The principle/function mechanism of the products is the first in China and has significant clinical application value. Among them, the branch aortic stent graft and delivery system technology is the first in the country to provide a new method for the clinical treatment of patients with thoracic aortic dissection; the folded artificial vitreous balloon is an innovative product independently developed in China and belongs to the international initiative. The product can be filled in the eyes for a long time, which solves the problems that the vitreous substitute cannot stay in the eye for a long time, can not press the retina for a long time or need repetitive surgery, etc., so as to avoid the removal of the eyeball and implantation of the prosthesis; the interventional artificial biological heart valve The market will bring significant clinical benefit to patients with aortic stenosis and aortic valve insufficiency. In addition, a number of medical device products with good clinical application prospects, such as drug-eluting balloon catheters, gene sequencing devices, and urinary free thiol detection kit (biochemical method), have been approved for registration.

According to the “Report” data, in 2017, the provincial food and drug regulatory authorities approved a total of 18,582 domestic second-class medical device registrations, an increase of 19.5% year-on-year. The state food and drug regulatory agency handled 2,315 of the first type of imported medical devices for record. The city-level food and drug regulatory authorities that are located in the districts have registered 13,203 items of the first category of medical devices in China. The national food and drug regulatory agency handled 5,181 changes in the registration of imported second, third and third category medical devices in accordance with their responsibilities. The provincial food and drug regulatory authorities handled 6,326 changes in the registration of Category II medical devices in China.