Chinese medical devices will usher in the golden age

Recently, Sinopharm Reed Exhibitions released the “2015 China Medical Device Industry Investment and Financing Annual Report” for the first time, focusing on the macro policy interpretation of China's medical device industry from the third quarter of 2014 to the third quarter of 2015, domestic and foreign investment and financing analysis and technology. Development trends and roadmaps, the author edited the main content of the report and shared it with everyone.

There is no doubt that the medical device industry will usher in a golden age.

First of all, a series of favorable policies are frequently released.

High-end medical devices have been explicitly included in the “13th Five-Year Plan”; the medical device industry’s parent law “Regulations on Medical Device Supervision and Management” has been officially revised; the state promotes the development and application of domestic medical devices, and guides the preferential procurement of domestically produced equipment to accelerate implementation. More import substitution products will accelerate the realization of more import substitutions; the “Made in China 2025 Key Area Technology Roadmap” encourages the level of medical device innovation and industrialization.

Second, market demand will be further expanded.

As China's aging trend further increases, the incidence of various diseases such as chronic diseases, degenerative diseases, and malignant tumors also increases, and the demand for medical devices corresponding to them will rise rapidly. From 1991 to 2013, the average annual growth rate of per capita medical expenses in China was 17.49%, which was significantly higher than the growth rate of China's per capita GDP in recent years. This is also one of the driving forces for the rapid development of the domestic medical device market.

From 2010 to 2014, the scale of China's medical device market has more than doubled. The total market volume has increased from more than 120 billion yuan in 2010 to 255.6 billion yuan in 2014, with an average annual compound growth rate of 20.8%. After that, China's medical device market is expected to continue to maintain such a high-speed growth momentum, reaching a market scale of 600 billion yuan by 2019, and its compound annual growth rate is expected to be about 19%.

From the perspective of industry research and market positioning, the medical device market can be divided into six categories: medical equipment , high-value medical consumables and implants, low-value consumables, in vitro diagnostics and testing, medical information equipment and other equipment. . Among these market segments, medical imaging equipment, in vitro diagnostic and inspection products and high-value medical consumables and implants are major components of the Chinese medical device market. In 2014, these three types of medical devices accounted for 19%, 16%, and 13% of total market sales, respectively.

In the case of clinical department classification, infusion equipment (in vitro diagnostic equipment and consumables), cardiovascular, imaging, orthopedics, ophthalmology, and other equipment in the infusion of puncture equipment are the major market share segment field.

Policy: Encourage innovation, strengthen quality and safety

In general, policy orientation is to gradually improve regulatory efficiency, encourage innovation, especially domestic key innovations, and strengthen quality and safety.

Improving the efficiency of supervision is mainly reflected in the supervision and management of the classification and classification of production enterprises. The change of one type of equipment from registration to filing, from pre-approval to after-accusation, does not reduce the quality requirements of a class of equipment, but allows the regulatory authorities to More energy to monitor the second- and third-class devices with higher risks is a major change in the regulatory thinking, and it also helps the regulatory authorities to improve the approval speed of the second and third types of devices.

Encourage innovation, mainly in the issuance of several regulations and normative documents. First, the medical device registration management method no longer requires the establishment of a production plant before the registration of medical devices. For some early-stage startups, the operating costs are reduced, so that they will More money is spent on the development of key technologies. In addition, the special approval process for innovative medical devices, commonly known as the establishment of green channels, has also increased the speed of major innovations and inspired more companies to engage in key innovations.

Strengthening quality and safety is mainly reflected in the formulation of quality norms and standards. Among them, it is worth mentioning that the medical device production quality management norms and management quality management regulations have been released, the medical device classification standards have been renewed, and more than 100 medical device industry standards have been issued, which have established quality specifications for the industry, although corresponding Some standards in the quality specifications have a certain gap compared with developed countries, but at least they have taken a solid step and laid a good foundation for subsequent improvement and optimization.

The rapid approval policy for innovative medical devices stipulated in the “Special Approval Process for Innovative Medical Devices (Trial)” has become an important highlight. Enterprises entering the green approval channel can get early intervention from the Food and Drug Administration, and local bureaus will be responsible for Communication with the company in research and development, clinical, and registration, the registration process does not require queuing during the review, and even the first registration fee for small and micro enterprises.

However, the conditions for reviewing innovative medical devices are relatively harsh. To sum up, the products to be applied need to have core technology invention patents according to law. The products are the first in China and are internationally leading. They have significant clinical application value and require basic product stereotypes. From the data point of view, the implementation of the 2014 regulations has been around, the overall application and pass rate is about 5:1. From the perspective of the application area, Beijing, Jiangsu, Guangdong and Shanghai are the most provinces and cities, which is directly related to the deep industrial base and entrepreneurial atmosphere of these places.

On October 3 this year, the advanced manufacturing in the medical field listed in the "Technology Roadmap for China Manufacturing 2025 Key Areas" includes two directions, namely biomedicine and high-performance medical devices. For this field, the relevant national planning is: “Improve the innovation capability and industrialization level of medical devices, focus on the development of high-performance medical equipment such as imaging equipment and medical robots, high-value medical consumables such as fully degradable vascular stents, wearable and remote. Mobile medical products such as medical treatment, and breakthroughs and applications of new technologies such as bio 3D printing and induced pluripotent stem cells."

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