DeviceChina2019 Gu Hanqing: Priority approval status and progress of medical device innovation

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(Summary description)DeviceChina2019 Gu Hanqing: Priority approval status and progress of medical device innovation

DeviceChina2019 Gu Hanqing: Priority approval status and progress of medical device innovation

(Summary description)DeviceChina2019 Gu Hanqing: Priority approval status and progress of medical device innovation

  • Categories:Yiweite news
  • Author:
  • Origin:
  • Time of issue:2019-09-12
  • Views:0

2019 China Medical Device Summit Forum (DeviceChina2019)

As the most important high-end conference focusing on the development of the medical device industry in China, DeviceChina actively builds an industry health ecosystem, discusses cutting-edge development trends, builds a professional communication platform, and seeks development solutions. It has attracted many well-known medical device inventors, medical scientists, entrepreneurs, investors and senior managers of multinational companies to participate in the conference, and has won a good reputation in the industry.

The 2019 Medical Device Innovation Week focused on presenting the latest cutting-edge policies and innovative development trends in the industry in three days, and from cardiovascular and cerebrovascular, imaging equipment, tumor-related equipment, surgery, orthopedic equipment and materials, medical artificial intelligence, in vitro diagnostics, upstream The supply of materials and accessories, the innovative design of medical devices, and the transformation of medical results have analyzed the cooperation mechanism of all parties in the industry, academia, research and marketing in the medical device innovation ecosystem from different perspectives, and discussed innovation policies with various innovation institutions and experts in the industry to boost China’s medical care Innovation and development of the equipment industry.

The 2019 competition and innovation week activities are expected to invite 100 senior academicians and experts, 30-50 overseas guests, and 30 national clinical research centers; attract 500 R&D and innovative companies or teams at home and abroad; convene hundreds of high-quality domestic and overseas Innovative projects participated in the roadshow, and 100 well-known innovation service institutions at home and abroad, and 100 top professional investment institutions were present.

At the main venue on the afternoon of September 5, Gu Hanqing, member of the National Medical Device Expert Review Committee, delivered a speech on the theme of "Priority Approval and Progress of Medical Device Innovation".





Gu Hanqing: At the National Science and Technology Innovation Conference in May 2016 and the 2018 Academician Conference of the Chinese Academy of Sciences and Chinese Academy of Sciences, Chairman Xi focused on the three aspects of scientific and technological innovation, the focus on scientific and technological innovation, the development of core technology of science and technology, and the innovation-driven development and construction of a technological power. Guiding opinions on relationships. After that, the Party Central Committee and the State Council issued the "National Innovation-Driven Development Strategy Outline", which made comprehensive arrangements for accelerating my country's innovation and development.

According to statistics, as of December 2018, nearly 1,000 applications for innovative products have been received, of which more than 60 are imported and the rest are domestic products. A total of more than 200 products have entered the national innovative medical device special channel, of which more than 40 products have completed registration applications and obtained product registration certificates. Chuangyou has declared more than 80 products and approved 20 items.

1. Which medical device products are innovative medical devices

Innovative medical devices refer to specific products, which clearly shows that the innovation is the product, not the technology. Of course, product innovation is inseparable from technological innovation, but the requirements for approval of the two are different.

According to the “Special Approval Procedures for Innovative Medical Devices” of the State Administration, products that also meet the following four points are innovative medical devices:

1. The applicant has the invention patent right of the core technology of the declared product in China, or obtains the invention patent right or the right to use it in China through transfer according to law; or the application for the core technology invention patent has been published by the patent administration department of the State Council.

2. The preliminary research of the product has been completed and the product has a basic finalized product. The research process is true and controlled, and the research data is complete and traceable.

3. The main working principle/mechanism of the product is a domestic initiative, and the performance or safety of the product is fundamentally improved compared with similar products, and the technology is at the international leading level.

4. The product has significant clinical application value.

2. Innovative medical devices should be the first in China

We emphasize two: The first emphasizes that the product's mechanism of action and the mechanism of action is a domestic initiative, and the second emphasizes fundamental improvements in product performance and safety, and the technology is at the international leading level. This article is correct in our review. A requirement of the technical level of invention patents, whether product invention patents or core technology invention patents, must be a domestic initiative. The domestically pioneered concept refers to the fact that no identical product in China has been approved for listing by the domestic medical device regulatory authority, that is, the declared product does not have a similar product on the market. In addition, the application of core technology makes the product fundamentally improved, and the inspection indicators for product performance and safety are statistically significant progress compared with similar domestic products.

3. The product has significant clinical application value

This is not to emphasize whether the declared product can be used, but refers to the comparison between the declared medical device and the similar product in clinical application, or whether there is any special contribution to the safety and effectiveness of the clinical application. The data should explain this.

The application of innovative medical devices is often accompanied by the birth of a new clinical solution. It must have advantages. This advantage not only requires companies to use actual verification to speak, but also requires documentary evidence and animal test data. Among them, articles published by authoritative institutions, There are articles published at home and abroad that can illustrate the problem.

Regarding clinical verification, in addition to testing reagents, other medical devices in clinical trials may not be completed. However, testing reagents have a certain amount of clinical verification, and none of them will not be approved. It is only for innovative reagents.

The above four aspects of work have been completed at the same time, and only those who meet the conditions can pass the expert review. After that, it still needs to be reviewed and approved by the Innovation Office work conference, and publicized for comments. Only those who have passed can be considered to be approved as innovative medical device special approval products.

In addition, if the declared product is a project approved at or above the provincial or ministerial level, please attach the stamped copy of the original approval. During the review, under the same conditions, projects approved at or above the provincial and ministerial level will be given priority.

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