Meet Urgent Needs for Clinical | Boosting Device Innovation

On March 28th, March 28th, the medical website of the “2017 medical device registration work report” was freshly 'baked'. The “Report” showed a panoramic view of the medical device registration acceptance and review evaluation in the past year, medical device review Progress of the examination and approval system reforms, and focused on the approval of innovative medical devices.

Data show that in 2017, national food drug Regulators accept the responsibility medical instruments Registered, continued 6834 applications for registration and licensing changes; completed 8579 technical reviews for registration applications; approved medical device registration, continued registration and licensing changes to 8923 registrations; 12 innovative products such as interventional bioprosthetic heart valves through special approval channels Accelerate the listing, meet the urgent need of clinical, for the people health Life brings the gospel, and science guides industrial innovation and development.

The reporter was informed that in 2017, the national food and drug regulatory agencies conscientiously implemented the "Regulations on the Supervision and Administration of Medical Devices", in accordance with the State Council's "Opinions on Reforming the Approving, Approving, and Approving System for Drugs and Medical Devices," the China Affairs Office, the State Council's "Deep Examination and Evaluation System The "Opinions on Reforming and Encouraging the Innovation of Drugs and Medical Devices" require the continuous deepening of reforms in the review, approval and approval system for medical devices, further strengthening the supervision and management of registration of medical devices throughout the country, and strengthening registration site inspections and supervision of clinical trials to continuously improve medical devices. Registration review review batch quality and efficiency.

The “Report” shows that in the past year, the national food and drug regulatory agency (the same below) has accepted registration of medical devices, and 6834 applications for continuation of registration and licensing changes have been recorded, which represents a decrease of 23.4% year-on-year. Among them, the acceptance of applications for registration of the third type of medical devices in China 2457 items, 4377 applications for registration of imported medical devices were accepted. 8579 technical reviews of medical device registration applications were completed, a decrease of 8.1% year-on-year. Of these, 1507 were registered for the first time, 5218 were continued, and 1854 were changed. Equipment Registration, Continuing Registration and Licensing Changes Registered 8,923 items, an increase of 3.1%. Among them, approved 1,379 medical device registrations for the first time. Approved 3,300 registrations of third type medical devices in China, an increase of 13.7% year-on-year. Approval of import medical device registration 5623 Items, a year-on-year decrease of 2.3%. 223 applications for registration of medical devices were not registered, and enterprises withdrew 331 items.

According to the “Report”, the third type of domestic medical device approved for registration in 2017, excluding in vitro diagnostic reagents, involved 25 sub-categories of products in the Catalogue of Medical Devices. The top five rankings for registrations are: Medical Polymer materials and products, implants and artificial organs, injection and puncture devices, medical optical instruments, instruments and endoscopic equipment, operating rooms, emergency rooms, and equipment and equipment for the treatment rooms. Among them, the number of medical polymer materials and products registered Significant increase of 56.5% year-on-year, from the second to the first; and the registration of implant materials and artificial organs dropped by 10.5%, ranking second; Medical optical instruments, instruments and endoscopic equipment and injection and piercing instruments The number of registrations was basically the same; the number of registrations for operating theatres, emergency rooms, and examination room equipment and apparatus products increased by 24.3%, ranking fifth. In addition to in vitro diagnostic reagents, imported medical devices approved for registration in 2017 were involved in the classification of medical devices. In the 40 sub-categories of the catalogue, the top five rankings for registrations are: implanted materials and artificial organs, medical optical instruments, instruments and endoscopic equipment, Dental Materials, Medical Polymer Materials and Products, Medical Electronics equipment Compared with 2016, implanted materials and artificial organs remained at the top of the list but fell by 5.1% year-on-year. Medical polymer materials and products, medical electronic equipment declined, and dental materials increased. Larger scale, replacing the operating room, emergency room, equipment and appliances in the examination room into the top five.

The "Report" mentioned that from the perspective of the registration of the third type of medical device in China, the production of related registered products enterprise Mainly concentrated in the coastal economically more developed provinces. Beijing, Jiangsu, Guangdong, Shanghai, and Zhejiang are the top five provinces in terms of the number of registrations for the third type of medical devices in China, accounting for 66.7% of the third type of medical devices registered in China in 2017.

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 “Innovative Medical Device Special Approval Procedures (Trial)”, and received 273 applications for special approval for innovative medical devices throughout the year, completing 323 reviews. (Including 2016 application items), 63 products were approved to enter the special approval path for innovative medical devices, and 12 innovative products such as registered branch-type aortic stent grafts and delivery systems were approved. Among them, there are 4 active medical devices, which are passive 8 items of medical equipment, an increase of 2 items.

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 main working principles/mechanism of the products are domestically initiated and have significant clinical application value. Among them, branch-type aortic stents and The delivery system technology is the first in the country to provide a new method for the clinical treatment of thoracic aortic dissection patients. The folding 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. Solved the vitreous body replacement can not stay in the eyes for a long time, can not long pressure pressure on the retina or need to repeat the surgery and other issues, to avoid eyeball enucleation and implantation of prosthetic eye seat; intervention of artificial biological heart valve market, will have aortic stenosis Patients and aortic insufficiency patients have significant clinical benefits. In addition, there are drug eluting balloon catheters, gene sequencing instruments, urine free thiol detection kits (biochemical methods) and other batches with good clinical application prospects. Medical device products are allowed to register.

According to the “Report” data, in 2017, the provincial food and drug regulatory authorities nationwide approved 18,582 domestic second-class medical device registrations, an increase of 19.5% year-on-year. The national food and drug regulatory agency handles the import of the first type of medical devices for registration in accordance with their duties. Projects. The municipal food and drug regulatory authorities that are located in districts throughout the country handle 13,203 items of the first type of medical devices filed in China according to their responsibilities. The state food and drug regulatory agency handles changes in the registration of imported second, third and third type of medical devices according to their responsibilities. Item. Each provincial food and drug regulatory department handles 6,326 items of registration change of the second type of medical device in China.