Domestic medical equipment welcomes important developments High-end equipment market develops steadi

Since September 30, China's medical device industry has also ushered in important positives: 359 applications for medical device registration can be exempted from clinical trials. The state's emphasis on the medical device industry and the release of various policies will be conducive to the sound development of China's high-end device market.

The second batch of catalogues will be reopened with "green light": 359 device products can be exempted from clinical trials

Recently, the State Food and Drug Administration issued the "Notice on the Issuance of the Second Batch of Medical Devices for Exemption from Clinical Trials" (hereinafter referred to as the "Notice"), which states that in order to implement the Regulations on the Supervision and Administration of Medical Devices ( Hereinafter, the relevant provisions of the "Regulations" are actively implementing the State Council's opinions on reforming the examination and approval system for pharmaceutical medical devices. The State Administration of the People's Republic of China has conducted extensive research, public consultation, and full research and demonstration. Under the premise of ensuring the safety and effectiveness of medical devices, According to the "Regulations", "Administrative Measures for the Registration of Medical Devices", and "Administrative Measures for the Registration of In Vitro Diagnostic Reagents", the organization has formulated the "Catalogue of the Second Class of Medical Devices Exempted from Clinical Trials (Second Batch)" and "Exemption from Clinical Practice". The third category of medical devices tested (second batch) expands the range of medical devices that are exempt from clinical trials.

The two catalogues published this time involved a total of 359 products, including 267 second-class medical devices and 92 third-class medical devices. Of particular concern is the inclusion of 15 second in vitro diagnostic reagents, such as the albumin detection reagent (bromocresol green method). The incorporation of in vitro diagnostic reagents is a good momentum for the vigorous development of the in vitro diagnostic reagent industry in China, and will further promote the rapid development of the in vitro diagnostic reagent industry.

Challenges and opportunities coexist. Domestic medical equipment breaks through zero tariffs

Despite this, with the approval of the implementation of the "Amendment of the People's Republic of China to the World Trade Organization Tariff Schedule", domestic medical equipment will still face a large-scale impact. In 2015, the total size of China's medical device market was about 380 billion yuan, nearly six times that of 2007. Although the growth is faster, imported medical devices still occupy the majority of the market in China. Multinational companies represented by GPS (General Electric, Philips, Siemens) have an absolute advantage in China's high-end medical device market. With the breakthrough of tariff barriers, it may be more difficult for domestic enterprises to break this pattern.

Domestic medical devices want to break the deadlock and must overcome the problem of too low localization rate. In recent years, the policy side has been frequently deployed. We are always striving to speed up the development of domestic medical devices and encourage domestic medical machinery to go out. Especially in the field of high-end devices, more energy is needed. Domestic enterprises should focus on product innovation and quality, and steadily proceed from the innovation of low-end medical device products, enhance their competitiveness, and then enter the high-end medical equipment.

High-end equipment market enters the development period Core technology and service is still a pain point

In the face of fierce competition in the industry, core technologies and services are still the pain points for the development of Chinese enterprises. For a long time, more than 80% of the high-end medical device market has been monopolized by multinational companies. Despite the rise of domestic high-end medical equipment manufacturers with independent research and development capabilities, it is inevitable that they will still be buying foreign core components and domestic assembly.

It is worth mentioning that the long-term monopoly of foreign domestic medical device market has begun to change. Zhao Zilin, chairman of the China Medical Equipment Association, said that China's medical equipment industry has entered the era of gold development, and the industry development will usher in earth-shaking changes. It is expected that by 2020, the medical equipment market will exceed 800 billion yuan. The huge market size has attracted many domestic enterprises to lay out high-end medical equipment. At present, the development of the domestic high-end medical device market mainly benefits from policy support. According to relevant statistics, only in 2015 the country introduced 18 relevant policies to support the development of domestic medical devices.

With the full implementation of various relevant policies, the domestic high-end medical device market has gradually entered a stage of steady development. Core technology and after-sales service are still the focus of various medical institutions, and it is also a difficult point that domestic enterprises need to overcome. Compared with the bottleneck of self-innovation ability, the equipment level of China's medical equipment can catch up with imported instrument enterprises and become the choice of the corresponding institutions.