What are the circumstances under which medical device production licenses are revoked

At the 2007 annual meeting of the China Social Security Forum, Wang Jun, vice minister of finance, said that the central financial arrangements for new rural cooperative medical care expenditures increased from 400 million yuan in 2003 to 11.4 billion yuan in 2007. Expenditures on rural medical aid increased from 300 million yuan in 2003 to 1.32 billion yuan in 2007. Minister of Health Chen Zhu said that the number of counties (cities and districts) covered by the New Rural Cooperative Medical Scheme should reach 80 percent of the total number of counties (cities and districts) nationwide in 2007, and that basically all counties (cities and districts) nationwide would be covered in 2008. Improve the coverage of the new rural cooperative, and the government to vigorously improve health care spending, these measures are to promote the new health care reform, "the basic medical security goals," an important factor. Benefiting from the healthcare reform are general pharmaceuticals and medical device manufacturers, especially the demand for low-end medical device products is the first to spread, and the relevant advantageous enterprises to obtain large orders for the upgrading of China's healthcare system. At the same time, related auxiliary products such as I.V. fluids, the concentration of pharmaceutical distribution increased, the relevant leading enterprises will enjoy greater benefits. From the perspective of the industry's operating environment, development trend, biological products sub-sector, medical equipment sub-sector and chemical API sub-sector to increase production trend is clear. However, from the point of view of the Development and Reform Commission drug administrative price cuts, rectify the medical industry commercial bribery, drug administration to strengthen the supervision of enterprises and other measures, the domestic pharmaceutical companies are facing greater pressure, the prosperity of the pharmaceutical industry is at a lower level. With the health care reform to the deep development of the pharmaceutical industry changes have intensified the differentiation of companies in the industry, the survival of the fittest to speed up the speed of purification of the industry's operating environment is very favorable, in the process will give birth to a number of future leading enterprises. Second, the centralized purchasing system of medical equipment in recent years, the relevant state departments through the implementation of government pricing of health insurance drugs, the abolition of hospitals to purchase their own and the implementation of centralized bidding and purchasing system, and gradually reduce the degree of dependence of hospitals on drug revenue. The accelerated reform of the medical system has undoubtedly become another booster for updating and completing the equipment of China's medical and healthcare institutions. For hospitals, without the support of drug revenues, it is difficult to survive by relying solely on financial subsidies. In this case, improving medical service income by remodeling hospital hardware and software conditions is an important way for hospitals to reduce their dependence on drug income. With the gradual rationalization of the domestic medical system, hospitals will gradually become the main protagonist of the medical service income, which will generate the demand for medium and high-grade medical equipment will constitute a sustained impetus for the development of the medical device industry. On the other hand, many small and medium-sized enterprises in the medical device industry have limited R&D capability and low technology level, and their only advantage may be the price. Once the bidding and purchasing is only based on the price, these low-technology products will definitely bring medical problems when they enter the hospitals. Medical device enterprises kill each other's price, enterprise profits gradually decline, which leads to the profits of enterprises can not be normalized, affecting the normal operation and R & D of enterprises. Third, China's accession to the WTO on the impact of the medical device market "WTO", is in line with China's reform and opening up strategic objectives, in general, China's economic development is favorable, China's reform and opening up is beneficial to the development of China's medical device industry will also have a far-reaching positive impact. With the reduction of tariffs in WT0 member countries, it provides very favorable conditions for the export of China's chemical APIs and medical devices to participate in international competition with more competitive prices; the reduction of the price of imported components needed for the production of medical devices will prompt a further decline in the production cost of our products; the reduction of non-tariff barriers between member countries to limit, for example, the strict requirements of certain countries to notarize the export of our commodities, Quality notarization, embassy notarization and Ministry of Health registration procedures, are conducive to China's medical equipment exports to all parts of the world. The weakening and elimination of non-tariff barriers will affect the market of some high-tech medical equipment products. High-tech medical equipment products through the efforts of our enterprises for many years, from scratch, B ultrasound, X-ray machine, MRI, X-CT, dental chairs, ECG recorder, catheters, syringes and so on have been close to the level of international products of the same grade, and have a strong competitiveness in the domestic market, and there are a certain number of exports. Therefore, it is also necessary to strengthen the cultivation of product competitiveness, give tariff protection, and more importantly, increase the support for enterprise technology development, and rapidly enhance the ability of enterprise R&D and market competition. From the point of view of the utilization of foreign investment and technical cooperation in China's medical device industry, foreign companies' investment and technical and economic cooperation in China have so far not brought in and transferred advanced technology. All they are interested in is to seize the market. Therefore, after entering the WT0, economic and technical cooperation is unlikely to make substantial progress in a short period of time. But in the long run, it is conducive to China's enterprises to more effectively utilize foreign advanced scientific and technological achievements and knowledge resources, which will have a huge role in the technological progress of enterprises. Fourth, the medical device quality management system standardization policy not long ago, the State Food and Drug Administration (SFDA) Medical Devices Division issued "on the development of sterile and implantable medical device manufacturers quality management system standardization of the pilot work of the notice". Industry insiders said that a regulatory authorities to promote the device quality management system standardization campaign has quietly kicked off. As in the case of drugs, medical device production will be fully mandatory to implement the norms, medical device companies GMP era has begun. The introduction of this policy is equivalent to the introduction of medical device manufacturers on a "spell", the implementation of the management system of medical device manufacturers to regulate. This provision raises the threshold of entry into the industry, standardizes the production and operation of medical devices, and thus improves the overall level of the medical device industry. The introduction of this new policy is conducive to the brand building of medical device manufacturers. At present in China, there are many manufacturers of medical devices, good and bad. Through the standardization of quality management system, it can make manufacturers in order to stand firm in the competition, and pay more attention to the quality of products, pay attention to the construction of their own brand. Fifth, the "supervision and management of medical devices regulations" to amend the new "supervision and management of medical devices regulations" to amend the idea of transmitting historic signals: medical device companies to get a license after the situation will be the end of the situation, the state from the source of the registration process to start. In mid-September SFDA press conference for the first time publicly stated that the "supervision and management of medical devices regulations" will be the core of the reform of the registration and management system, and will be the principle of the enterprise as the first person responsible for the implementation of the revision of the revision of the new always revised. The new "supervision and management regulations of medical devices" revised ideas to convey a historic signal: medical device companies to get a license after the situation will be the end of the situation, the state from the source of the registration process to start, throughout the regulatory system will be able to establish. The current "supervision and management of medical devices regulations" in April 1, 2000 implementation. The current "Regulations" on medical devices to implement the production of product registration system, that is, the legitimacy of medical devices is based on whether or not the registration as the main basis for determination. The idea of the new "Regulations" is to focus on direct verification of the registration process, from the source of the gatekeeper. China's large number of medical enterprises, and domestic production of mostly small and medium-sized equipment, low-end consumables, as of the end of April this year, the country **** there are 12,242 medical device manufacturers, of which a class, class II manufacturers 10,166, accounting for 83%; Class III manufacturers 2076, accounting for only 17%. Industry structure optimization, improve concentration is an inevitable trend. Grasp the "source" of this idea has been reflected in the actual regulatory work: since the middle of last year, there have been 328 medical device companies have been revoked production licenses, 285 companies voluntarily withdrawn, 98 companies have been ordered to suspend production and rectification. Combined with two months ago, the Ministry of Health issued a recall of the right to purchase medical devices, the industry to accelerate the reshuffle is worth looking forward to.