Machinery / Industrial Parts & Tools

Make every effort to tackle key core technologies such as medical devices and chemical reagents!

On May 28, at the 20th Academician Conference of the Chinese Academy of Sciences, the 15th Academician Conference of the Chinese Academy of Engineering, and the 10th National Congress of the China Association for Science and Technology, General Secretary Xi Jinping delivered an important speech and emphasized that scientific and technological research must be problem-oriented. , Rushing to the most urgent and pressing problems, starting from the urgent and long-term needs of the country.

We must make every effort to tackle key core technologies in oil and gas, basic raw materials, high-end chips, industrial software, crop seeds, scientific test equipment, chemical preparations, etc., and accelerate breakthroughs in a number of key fields such as medicines, medical devices, medical equipment, vaccines, etc. Core technologies. It is necessary to target frontier fields such as artificial intelligence, quantum information, integrated circuits, advanced manufacturing, life and health, brain science, biological breeding, aerospace science and technology, and deep seas in the basic core areas related to the development of the overall situation and national security, and make forward-looking deployments. Approve strategic and reserve technology research and development projects, aiming at the commanding heights of future technology and industrial development. To optimize financial investment in science and technology, focus on investing in strategic and key areas.

Coincidentally, in order to promote the independent controllability of high-end medical inspection equipment and improve the clinical application and development of domestic inspection equipment, on May 29, the "2021 High-end Medical Inspection Equipment Independent and Controllable Development Forum" was held in Changchun. Industry experts, medical institutions, and enterprises jointly discussed the independent and controllable development strategy of domestic high-end medical equipment, and jointly established an independent and controllable medical and health system.

It can be said that we are working hard from top to bottom to build a country with a strong science and technology and a strong quality!

1. The epidemic is forced to solve the "stuck neck" dilemma

With the continuous improvement of people's requirements for a healthy life, the demand for technological development in the fields of biomedicine and medical equipment has become increasingly prominent. my country has also been vigorously supporting technological innovation in the research and development of chemical preparations and medical device products. However, due to factors such as technical barriers, R&D restrictions, and top-level design, my country's medical device industry is still in the stage of tackling tough problems and is facing a "stuck neck" dilemma.

The epidemic has hit the global economy hard, but it has also forced leapfrog progress in technologies such as rapid testing, medical imaging, and vaccine drugs. The demand for diagnostic testing brought about by the new crown epidemic in 2020 has further boosted the growth of the IVD industry.

It is particularly worth mentioning here that during the new crown epidemic, China's entire IVD industry chain ushered in a great breakthrough when the global supply chain was extremely unstable. On the raw material side, companies such as Philippeng, Novartis, Yisheng, Bepsys, Boyue, Hanhai New Enzyme, etc. have rapidly innovated and provided key raw materials such as antigens, antibodies, molecular enzymes, etc. required for the development of reagents; Shengxiang, Wanfu, Kayudi, Ustar and other companies have made breakthroughs in technological innovation and developed miniaturized molecular POCT equipment, which is more convenient and quick to invest in epidemic prevention and control; medical testing such as Golden Mile Medical, Daan Diagnostics, and Cap Test Large-scale testing services have been realized, and BGI has created an on-site testing site in the Huoyan laboratory, and numerous innovations and technical problems have been broken through. Mindray recently invested heavily in the acquisition of core companies in IVD raw materials, hoping to achieve a leap in core technology.

2. 100 innovative devices were approved for listing, and only 4 imported products

In order to encourage and support breakthrough innovation, the Food and Drug Administration issued the "Special Approval Procedure for Innovative Medical Devices (Trial)" in February 2014, setting up special approval channels for innovative medical devices for the first time.

According to incomplete statistics, as of the end of 2020, more than 300 medical device products have entered the national innovative device approval process. As of 12:00 on January 13 this year, 100 innovative medical device products with strong innovation, high technical content and urgent clinical needs have been approved for the market.

Among these 100 products, 96 are domestic products, involving 78 medical device companies in 14 provinces, autonomous regions and municipalities directly under the Central Government, accounting for 96% of all products; 4 are imported products, involving 4 companies in two countries.

In terms of product characteristics, there are 43 active devices, 37 passive devices, and 20 in vitro diagnostic reagents and equipment.

3. Import substitution has accelerated, and the number of import registrations has been drastically reduced

In general, under the escort of policies, in recent years, domestic medical devices have accelerated their research on key core technologies, broke through technical equipment bottlenecks, gradually improved product R&D and technological innovation capabilities, and achieved fruitful import substitution.

According to statistics from the Zhongcheng Medical Devices big data platform, the number of imported medical device product filings and registrations will be significantly reduced in 2020.

In 2020, a total of 493 imported medical equipment category II and III products nationwide were registered for the first time, a year-on-year decrease of 161 pieces, a decrease of 24.6%; a total of 713 category I products were registered, a year-on-year decrease of 702 pieces, a decrease of 49.6%; 47 continued registrations, a year-on-year decrease There were a decrease of 914 cases, a decrease of 95.1%. The number of expired and cancelled imported products has increased significantly, with a total of 3110 expired and cancelled products, an increase of 2169 pieces or 230.5% year-on-year. The number of filing and registered agents has decreased, with a total of 2,421 imported product agents, a 4% decrease from 2019 (2,519). By the end of 2020, there will be 9,694 category Ⅰ products, 9053 category Ⅱ products, and 7966 category Ⅲ products nationwide.

4. Continuous breakthroughs in the core technology of high-end medical equipment to achieve independent control of the entire chain

For a long time, more than 80% of the high-end medical equipment market has been monopolized by multinational companies. Although the domestic high-end medical device market has entered a period of rapid development, key basic materials and core basic components are still pain points for the further development of high-end medical devices.

The "14th Five-Year Plan" mentions breaking through core technologies such as endoscopic surgical robots and extracorporeal membrane oxygenation machines, and developing high-end imaging, radiotherapy and other large-scale medical equipment and key components.

On May 29, the "2021 High-end Medical Inspection Equipment Independent and Controllable Development Forum" was held in Changchun. Industry experts, medical institutions, and enterprises jointly discussed the independent and controllable development strategy of domestic high-end medical equipment, and jointly established an independent and controllable medical and health system.

The Guangdong Provincial Health Commission also issued the "Announcement on the List of Imported Products of Provincial Health Institutions in 2021" at the beginning of the year. The announcement showed that the number of imported medical equipment that can be purchased has been reduced from 132 to 46, which means that domestic medical equipment will be imported. The scope of hospitals was expanded again, and the import substitution of domestic equipment accelerated.