China's medical device industry is in a period of rapid development. In 2014, the market scale exceeded 300 billion yuan, accounting for 17% of the pharmaceutical market. However, there are still some difficulties, such as low level of scientific and technological innovation; low level of industrialization; high-end medical equipment is basically monopolized by foreign countries; in the bidding, domestic and imported products are of the same price and so on. How do domestic medical devices break through? How to lead the trend in building an innovative country?

Encourage innovation to strengthen risk control

In the entire international medical device market, the United States ranks first, the EU ranks second, and China's medical device industry ranks third in the world. However, as far as the international market is concerned, China accounts for about 11%, which is still insufficient. In the pharmaceutical industry in developed countries, the ratio of the pharmaceutical market to the device market is 1:1. After rapid development in recent years, China's medical device market has accounted for 17% of the pharmaceutical market. There is also a welcome phenomenon. Among the total imports and exports of Chinese medicine, the proportion of medical devices is relatively high, accounting for nearly 38%, which proves that medical devices are very active in the import and export of Chinese medicine.

There are more than 15,000 medical device companies in China, which are still dominated by “multiple, small, scattered and low”. In both domestic and international markets, China's low-end medical devices occupy a large position, while in the high-end medical device market, the proportion of domestic products is not high, mainly because our level of innovation is low.

At present, the State Food and Drug Administration has supervised and managed the entire process of research and development, production, operation and use of medical devices in accordance with the new “three-set” plan of the State Council. In particular, the innovation of the entire domestic medical device is a key concern of the State Food and Drug Administration in the past two years.

In response to the issue of innovation system, in 2014, the State Council issued a new Regulation on the Supervision and Administration of Medical Devices. In this regulation, on the one hand, it encourages innovation; on the other hand, in the risk management of medical devices, it not only strengthens the main responsibility of the enterprise, but also strengthens the management of the use link and related rules.

On this basis, in February 2014, the “Special Approval Process for Innovative Medical Devices (Trial)” was issued, which was implemented on March 1, 2014. From March to the end of last year, there were more than 100 officially declared domestically-included imported medical devices. After expert review, there are 15 companies that have entered the approval channel. These 15 are currently made in China. Based on the fact that one is guided by clinical needs, the second reflects international innovation.

In order to reflect these two orientations, to avoid the government's "shooting the head" decision, which innovative products can enter the review process, it is recommended to initiate the reform of the entire review system. This reform is inevitably a comprehensive use of various reform policies.

Although the enterprise is the main body of innovation, it can only promote the innovation and development of the entire domestic medical device through the joint efforts of enterprises, government departments, clinical experts and other parties under the support of various related policies.

Establish a third-party evaluation agency

We very much hope that domestic medical devices can occupy a dominant position in China's medical market. Especially from this year, we must further increase the intensity of medical control fees. Medical devices occupy a very important weight in the entire medical service market. Therefore, increasing the market supply of domestic medical devices is in line with immediate economic interests as well as long-term Strategic significance.

For domestic medical devices, we hear two different sounds. In terms of enterprises, whether it is a state-owned enterprise or a private enterprise, it is said that the quality of domestic production is very good. Our quality is no less than that of foreign products, or it is close to the level of foreign products. However, the feedback from the clinical side said that there is still a certain gap in the quality of domestic products and imported products, especially after-sales service. There is still a big gap.

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