Central setting: the localization of medical devices is on the way!

Source: China Medical Devices / Jiang Haihong 2015-05-12 May 9, notice of the general office of the State Council on printing and distributing 2014 work summary and 2015 key work tasks of deepening medical and health system reform (GBF [2015] No 34) In summary of the achievements in 2014, the circular mentioned that it continued to strengthen the investment in new drug development and medical device localization, and studied policies and measures to promote medical device localization While talking about the achievements, he also put forward the key tasks in 2015, that is, to improve the technical requirements for priority review, and to implement the special approval procedures for innovative drugs and medical devices According to the regulatory situation of medical devices, learn from the international regulatory experience, improve the classification of medical devices and the requirements of registration review and approval At the same time, it is required to strictly control the size of beds, construction standards and large-scale medical equipment allocation in public hospitals, give priority to the allocation and use of domestic medical equipment and devices in public hospitals, and accelerate the development of major new drugs and the localization of medical devices It can be seen that this is an obvious signal that the country will seek to break the current dilemma of low level of medical device localization in 2015, and it is expected that there will be corresponding policies to continue to follow up In the second half of the year, the supporting policies launched by the Ministry of science and technology, the health and Family Planning Commission, the State Food and Drug Administration and other ministries and commissions may include: improving the registration, review and approval of medical devices, loosening the allocation of large-scale medical devices, reducing the inspection fees for large-scale medical devices, and increasing the investment in domestic science and technology In May 2014, Xi dada inspected Shanghai Lianying company, bringing this seemingly "unknown" domestic high-end medical enterprise into the public view It is generally believed that Xi dada's inspection of the joint film is a concentrated reflection of the support of the senior level of the state for the localization of medical devices Since then, various ministries and commissions have issued corresponding policies to practice greatly in the joint film speech, let medical device practitioners shout! However, the pace of localization of medical devices is not rapid, and the situation that domestic devices lag behind foreign large-scale medical devices has not been fundamentally changed! What's the reason?! It should be said that the Ministry of science and technology has launched the "digital medical engineering technology development" project, the drug administration has issued the special approval procedure for innovative medical devices, the health and Family Planning Commission has carried out the selection of excellent domestic equipment and promoted the hospital to select more domestic equipment There is no doubt that these policies have unlimited benefits for domestic medical equipment, but it will take time to play a role What's more, it's hard to make progress in the industry of equipment localization just because leaders attach importance to it, and the resounding slogans are useless We have to put in solid efforts For the high proposition of medical device localization, the author's opinions are as follows: first, medical device, spell the comprehensive national strength of the country! Medical devices are responsible for the category, with high technology content and strong cross cutting, involving knowledge of multiple disciplines, which is a touchstone to measure the overall level of science and technology of a country Many of the scientific and Technological Development Trends of advanced countries are first reflected in the field of medical devices Especially the development of large-scale medical equipment is the embodiment of a country's scientific and technological strength Whether it's MRI or heavy ion cancer treatment device, there's no corresponding development of science and technology, so it's empty talk to realize localization! The improvement of comprehensive national strength is not something that can be achieved overnight, there is still a long way to go! 2、 Chinese and foreign equipment PK, large-scale medical equipment is the main level of domestic and foreign medical equipment PK, a higher main battlefield should be the competition of large-scale medical equipment At present, although the development of large-scale equipment in China has improved, it is still difficult to shake the status of foreign large-scale equipment in China This is not only a reality, but also a dilemma Xi dada first went to the previously "unknown" joint film inspection instead of the famous Mindray The reason is that Xi dada should promote the development of large domestic equipment Although Mindray has a great reputation in the industry, most of the equipment it produces is small body and less heavy equipment Therefore, I dare to say that the localization of medical devices should focus on the development of large-scale medical equipment, otherwise, it is to pick up sesame seeds and throw watermelon! 3、 The premise of device localization and breaking foreign monopoly is that according to the public information, the "troika" of medical devices, such as General Electric of the United States (GE), Siemens of Germany and Philips of the Netherlands, have firmly held 70% of the domestic market share, and more than 80% of the high-end market share has been occupied by multinational enterprises, and domestic medical devices survive in the narrow gap Due to the complexity of high-end precision instrument technology, high investment in research and development, and the difficulty of replacement, the field of high-end medical devices is still the world of multinational companies In order to realize the equipment localization smoothly, breaking the monopoly of foreign capital is the premise And its effective means should be to master more core technology of products 4、 Some people think that the long-term monopoly of multinational medical equipment companies not only directly causes the difficult situation of high purchase cost and high maintenance cost of medical institutions, but also brings price obstacles for patients to see a doctor and check up The greater the impact of domestic and local brands on foreign manufacturers, the greater the future "low price war" will benefit the people But the author thinks that the pure "price war" should give way to "technology war" Only when we defeat our rivals in terms of technology can we break the monopoly of foreign capital However, the development of medical device education in China lags behind the market demand, and the lack of senior technical personnel has a serious impact on the upgrading of medical device technology Recently, the case of Siemens being investigated in Wulong has become a conversation after dinner Some people think that the multinational giant represented by GPS has dominated the high-end value chain of medical devices in China for many years, which is one of the important reasons for the high cost of medical treatment in China This event will cause more attention to the urgency of the localization of high-end medical devices, and is expected to continue to accelerate the pace of the localization of high-end medical devices in China In fact, in my opinion, this is the bad thinking of some Chinese people who want to profit from it by watching the fire from the shore They hope that their opponents will fall down at the same time when they are not strong, so that they hope to become the market leader However, with the deepening of the reform of the medical system, the improvement of people's health awareness and the aggravation of the aging of the population, the market space of medical devices in the grass-roots and non-public medical institutions is vast, which is a rare opportunity for the rapid development of domestic medical devices.