2019年12月17日星期二

The spring breeze of policy promotes the development of the medical device industry

The Chinese medical device industry grew rapidly from small to large, from the initial stages of primary health materials to the initial stage of expansion, and to the stage of structural changes promoted by private capital in the 1990s, the Chinese medical device industry completed its original technology and Accumulation of capital, and preliminary realization of product structure adjustment and regional industrial layout. After the new medical reform started, the industry ushered in a new historical period. Now it has become a sunrise industry with relatively complete product categories, continuously enhanced innovation capabilities, and strong market demand. In particular, in recent years, the pace of development of the medical device industry has further accelerated, and the market scale has maintained high growth for many years, and the quantity and technological content of product exports have also been continuously improved. In 2016, China's medical device industry achieved a total sales revenue of 244.8 billion yuan, a year-on-year increase of 7.9%. With the further growth of the demand for medical and health care by our residents, it is expected that the market size of China's medical device industry will reach 290 billion yuan in 2018.

From the perspective of the product structure of China's medical device market in the past three years, imaging diagnostic equipment has occupied the largest market share, and has remained at around 40% in recent years, and has been on the rise. Followed by various types of consumables, accounting for about 20% of the Market share; The market share of orthopaedic and implantable medical devices continues to decline; the remaining market share is occupied by dental and other types of devices.

Medical Device Industry Competition Analysis

As China's medical device industry started relatively late, foreign medical device companies with earlier development and advanced technology will soon gain market leadership status after entering the Chinese market. In order to change and regulate the domestic medical device market, the Chinese government has continuously issued policies and measures to simplify administrative approval procedures, provide support in R&D and export tax rebates, and encourage domestic innovation and import substitution of medical devices.

Thanks to the support of national policies and the increase in industry demand, China has completely achieved import substitution in low-end medical device products. In the high-end areas, companies are also increasing their R&D technology levels. It is worth noting that in 2018, the reform of grading diagnosis and treatment will continue to deepen and gradually spread across the country. Classification medical treatment will bring the allocation of medical resources to the grassroots and will mean more opportunities for domestic equipment. The vast grass-roots medical market has always been an active land for domestic brands. On the policy level, the state encourages and supports grass-roots medical units to use excellent domestic medical equipment and equipment. In the next two years, the field of basic equipment, inspection and diagnostic equipment, household equipment related to chronic diseases, medical rehabilitation equipment, follow-up equipment for doctors, and ultrasound and other safe and convenient imaging equipment will become the focus of attention.

However, in the high-end medical market, foreign medical device companies have long dominated the market. When competing with foreign advanced medical device manufacturers, most domestic companies still rely mainly on price warfare and have little or no advantage in the high-end field. From the perspective of the international development experience of the industry, R & D strength to a certain extent determines the quality and level of industry profitability.

The spring breeze of policy promotes the development of the medical device industry

The development of the medical device industry has a bearing on the achievements of the “great health” construction of our residents. The Chinese government has issued more than a dozen policies over several years, providing convenience for the development of the medical device industry in all aspects.

In November 2017, the State Food and Drug Administration issued the "Technical Guidelines for Accepting Medical Device Overseas Clinical Trials". The guiding principles put forward the ethical principles, legal principles, and scientific principles for receiving data from overseas clinical trials, and defined the data requirements and technical requirements for overseas clinical trial data. The guiding principles elaborated the considerations and technical requirements for the acceptance of overseas clinical trial data from the aspects of technical review requirements, the population under study, and the differences in clinical trial conditions, and gave the clinical significance of the impact of different factors on clinical data. Specific examples.

The publication of this guiding principle will help avoid or reduce repetitive clinical trials and accelerate the process of listing medical devices in China. At the same time, it will also further shorten the cycle of research and development and application of medical devices in China, and help accelerate the development of the medical device industry.

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