Analysis of 2017 Medical Device Registration Work Report

▲ Domestic Tertiary List of Medical Device Registrations

▲ Imported medical device registration product bitmap

On March 28th, March 3rd, the Medical Network released the 2017 Medical Device Registration Work Report (hereinafter referred to as the “Report”). With detailed contents and data, it fully displayed and analyzed the medical device registration management in 2017 in China. Progress. The "Report" shows that in 2017, China's medical device registration management Regulation The system has been continuously improved, the reform of the examination, approval and approval system for medical devices has been further advanced, the registration of medical devices in China has grown significantly, and the awareness of independent innovation in the industry has increased.

In 2017, the National Medical Device Regulatory Agency coordinated the completion of the "Regulations on the Supervision and Management of Medical Devices" and issued the "Measures for the Administration of Medical Device Standards," "Amendment to the Administrative Measures for the Registration of In vitro Diagnostic Reagents," and "Administrative Conditions and Record Management for Clinical Trials of Medical Devices". 》and other regulatory documents.

The "Report" pointed out in this regard that the gradual improvement of the regulatory system for medical device registration management has provided institutional guarantees for China's medical device registration management and provided a good regulatory basis for the orderly implementation of registration applications for medical device companies.

The medical device standard is a unified technical requirement for the development, production, operation, use, and supervision of medical devices. It is an important symbol for the development level of the medical device industry. In 2017, the National Medical Device Regulatory Agency revised and issued the “Revision and Administration of the Medical Device Standards. The Code stipulates the work procedures for standard system revision; organizes and develops 86 revisions of the medical device industry standards, and reviews and publishes 98 medical device industry standards such as the “Requirements for the Quality of Medical Device Quality Management System for Regulations”.

Scientific and rational classification of medical devices is an important basis for the whole process of medical device supervision. In 2017, the National Medical Device Supervision and Administration Department organized the Medical Device Classification Technical Committee and released the new Catalogue of Medical Devices, and actively promoted it. Training work; complete allergens, flow cytometry, immunohistochemistry and in situ hybridization in vitro diagnostic reagent product properties and class adjustment work, reasonably reduce the relevant product categories, meet the clinical use needs.

In 2017, the National Medical Device Regulatory Agency fully promoted the reform of the review, approval and approval system for medical devices. In particular, last October, the China Affairs Office and the State Council’s “Encouragement on Deepening the Review, Evaluation and Approval System”. drug medical instruments After the release of the "Innovative Opinions" (hereinafter referred to as "Opinions"), the pace of reforms has been further accelerated.

In improving the review mechanism and optimizing the review process, it has successively issued the “Measures for the Management and Communication of Medical Device Evaluation and Communication (Trial)” and “Announcement on the Release of the Administrative Measures for the Expert Consultation Committee of Medical Device Technology Evaluation” “Regulating the adjustment of some medical devices. Decisions on the Examination and Approval Procedures for Administrative Examination and Approval Matters. The release of the third batch of medical device catalogs for clinical trials, exemption of clinical trials for 164 medical devices, and reduction of burden on administrative counterparts.

Inspired by the Opinions, applications for registration of domestic medical device innovation products have been surging. In 2017, the national medical device supervision department received 273 applications for special approval for innovative medical devices, and finally approved the registration of 12 innovative products. The company has added two new products. In addition, it also approved the drug eluting balloon catheter produced by Liaoning Haoyi Biotechnology Co., Ltd., a gene sequencing device produced by Wuhan Huada Zhizao Technology Co., Ltd., produced by Shen Rui Biological Products Co., Ltd., Wuxi City. The urine free thiol detection kit (biochemical method) and some other medical device products with good clinical application prospects are registered.

Medical device clinical trials are an important measure to ensure the safety and effectiveness of device products. The “Report” shows that in 2017, the supervision and inspection of medical device clinical trials continued to increase, and 2 batches of medical device clinical trials were supervised and inspected in the year. Family enterprise Of the 19 registered application projects, conducted inspections on the 38 clinical trial institutions involved, and refused to register 3 applications for registration with authenticity issues, and decided not to accept the application again within 1 year from the date of non-registration. Effectively purify the clinical trial environment for medical devices. During this period, a total of 169 companies actively withdrew 261 medical device registration applications.

In addition, in response to the actual development of domestic medical devices, the National Medical Device Regulatory Agency has also issued the Guiding Principles for the Technical Review of Medical Device Network Security Registration, the Guiding Principles for the Technical Review of Mobile Medical Device Registration, and the Guiding Principle for the Division of Medical Device Registration Units. Released guidelines for technical review of 80 medical device registrations, including the cochlear implant system, medical magnetic resonance imaging system, and hip prosthesis system, effectively unified relevant review requirements, and guide related industries to specifications. health The development is of great significance.

The continuous specification of clinical trials and review requirements has boosted the development and expansion of domestic devices. From the data in the Report, we can see that compared with 2016, the registration of Class II and Class III medical devices in China in 2017 has been approved. The number has increased significantly. Among them, 3,300 medical device registrations (domestic medical devices, 1,910 medical devices, 1,390 in vitro diagnostic reagents) have been approved, an increase of 13.7% compared to 2016; 5,623 medical devices have been approved for import (imported second category There were 2823 medical device registrations and 2,800 registrations of imported type III medical devices. This was a decrease of 2.3% compared to the same period of last year. It is worth noting that the number of registered medical grade high- The number of products registered increased by 56.5% compared to 2016.

At the same time, the number of registered medical devices in the second category in China has also increased significantly. Last year, provincial food and drug regulatory authorities approved a total of 18,582 domestic second-class medical device registrations, an increase of 19.5% over 2016.