Priority approval, time limit compression!The approval of the second category of medical device in Jilin Province ushered in major benefits

In order to serve the technological innovation of medical device products in all directions, accelerate the listing of advanced medical device products as soon as possible to meet the needs of public equipment. Recently, the Provincial Pharmaceutical Supervision and Administration Bureau issued the "Jilin Province Second Class of Medical Device Innovation Product Registration Approval Procedures (Trial)" "Jilin Province's Second Class of Medical Device Priority Examination and Approval Procedures (Trial)", "Jilin Province Second Class of Medical Device Emergencies Emergencies (Trial)" three institutional documents.

In recent years, the medical device industry in our province has shown a booming trend and has become a new economic growth point for the province's pharmaceutical and health industry. As of the end of 2021, the province's medical device manufacturers increased to 536 households, an increase of 75.7%in the past two years; the second type of medical device registration certificate was 1,841, the increase of 46.3%in the past two years, and the output value of medical device 6 billion yuan. In the past two years 50%.

So, what important contents of the three systems introduced this time, and what changes will it bring to the development of the medical device industry in our province? On June 28, at a press conference held by the Provincial Government News Office, the Provincial Drug Administration made a detailed interpretation.

01 | Innovative product registration approval, focus on four aspects of review

The "Jilin Province Second Category of Medical Device Innovation Product Registration Approval Procedures (Trial)" issued this time clarified the scope of registration and approval of the second category of medical device innovation products, procedures and time limit for registration and approval of the province. %above.

In the innovative product approval procedure, the conditions for applying for the application of innovative product registration for the second type of medical device registration application in the province will focus on the four aspects of the four aspects:

First, have core technologies. Through its leading technological innovation activities, the applicant has the patent rights of the core technology of the product in accordance with the law in accordance with the law.

Second, the product is basically set. The applicant has completed the preliminary research of the product and has basic styling products. The research process is real and controlled, and the research data is complete and traceable.

Third, the product is the first in China. The main working principle or mechanism of product work is the first in China. The product performance or safety is more fundamentally improved and similar to similar products. It is technically at the international leading level and has significant clinical application value.

Fourth, technology is leading in China. Medical equipment technology is the leading domestic leader and fills the gap in our province.

02 | Four categories of products, you can apply for priority approval

"Jilin Province Second Class of Medical Device Priority Approval Procedures (Trial)" has made specific regulations on the priority approval procedures for the second category of medical device in our province, and clarify that the four types of medical device products can apply for implementation and approval:

The first is the medical device that needs to be transformed in innovative scientific and technological achievements. It will be included in the major special projects, key research and development plans for science and technology in the country, Jilin Province, or Jilin Provincial Science and Technology Special, Scientific and Technological Innovation Action Plan, the Provincial Party Committee and Provincial Government to promote major projects, the Ministry of Industry and Information Technology, or Jilin Province's "Specialized New", "Little Giant", "Little Giant" "The company's medical devices for its core competitiveness of the core competitiveness are incorporated into the scope of priority approval.

The second is to meet medical devices that need to be urgently needed and have obvious clinical advantages. The diagnosis or treatment of rare diseases and malignant tumors has obvious clinical advantages. Diagnosis or treatment of elderly people and multiple diseases, and there are currently no effective diagnosis or treatment methods. It is dedicated to children and has obvious clinical advantages. Medical devices that are urgently needed clinically and have been registered in our province have not yet been approved for registered products.

Third, the review of the Medical Device Technology Review Center of the State Drug Administration (hereinafter referred to as the National Bureau of Instrumentation) has been included in the "Medical Device Priority Examination Procedure" and confirmed that it is the second category of medical devices in the country.

Fourth, the product's medical device manufacturers that meet the development of national or the provincial industry development plan moved to the province with registered products. In the provincial medical device that is verified by security and effectiveness, it will give priority to approval.

03 | Open the emergency approval channel to promote the rapid listing of medical equipment

"Jilin Province Second Class of Medical Device Emergency Approval Procedures (Trial)" includes four aspects: applicable scope, approval process, work duties, and post -post supervision. Specific regulations have been made on the emergency approval of the second category of medical device in our province, which provides basic follow. In the future, the Provincial Pharmaceutical Bureau will take six major measures to promote emergency medical device products to quickly go public:

First, start quickly. When there is a threat of public health incidents, and after the emergency public health incident, the Provincial Pharmaceutical Regulatory Bureau formulated and dynamically adjusted the "Jilin Provincial Second Medical Device Emergencies Emergency Approval Catalog" to open an emergency approval channel. After the emergency approval procedure is launched, in accordance with the principles of unified command, early intervention, follow -up, and scientific approval, it will accelerate the development of product inspection, on -site inspection, technical review, administrative approval, etc., and promote the rapid listing of emergency registration of medical device.

Second, synchronous acceptance. For emergency medical devices, the applicant's application for product registration can simultaneously carry out product inspection and application for production permits.

Third, priority inspection. If the applicant entrusts the provincial medical device inspection and research institute to conduct inspection, the Provincial Medical Devices Inspection and Research Institute shall organize medical device inspection within 24 hours after receiving the sample, and issue inspection reports in a timely manner.

Fourth, priority system verification. The Provincial Drug Administration organizes a check -up quality management system to verify the quality management system within 2 days.

5. Priority review approval.The Provincial Drug Administration completed the technical review within 5 working days, completed the administrative approval within 2 working days, and delivered the applicant within the day.6. Synchronous issuance.The Provincial Pharmaceutical Supervision Bureau will be combined with the inspection of the production license and the registration system.

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