The production of Class II and Class III medical devices should be clinically validated. As said the production of Class III medical devices, by the State Council drug supervision and management department for examination and approval, and issued a certificate of registration for the production of products.
Class III medical devices, such as artificial heart valves, artificial joints, vascular stents, implanted in the human body hemostatic gauze and so on.
Note that there are many hemostatic gauze, soluble hemostatic gauze on the market now, but only three types can be implanted in the body, absorbed by the body, do not have to take out of the class II hemostatic gauze can only be used for the body surface, although the second type of manufacturers to publicize can be used in the body, but is not in line with the law, but also prone to problems.
Currently, the state of the third class of medical devices safety and effectiveness to take strict control management.
Medical equipment is a big matter of life and death, but also the state focus on the field of supervision, but some manufacturers of profit-making behavior resulting in this field of mixed, advise the operators in the profit-making at the same time pay more attention to the product's substantive role, and absolutely not allowed to exaggerate the role of a product.
Article V of the State of medical devices to implement classification management.
The first category refers to the routine management of medical devices sufficient to ensure their safety and effectiveness.
The second category refers to its safety and effectiveness of medical devices should be controlled.
The third category refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices.
The third category must be controlled, the highest risk factor, if not controlled, human life is at stake ah!
Related links: the global financial crisis on the medical device industry
Currently the world is facing a financial crisis, this financial crisis is not the most serious financial crisis occurred in the past 100 years, the financial market crisis is a leading indicator of recession, but in the past history of the health care industry does show good resistance. Meanwhile around the world, merger and acquisition activity in the healthcare sector remains strong. It is because of China's relative stability during the financial tsunami and the healthcare industry's resilience to shocks, coupled with the high profitability of the medical device sub-sector, that capital continues to pour into it.
Currently, there is a gap between China's medical device industry and that of developed countries, but the speed of development of China's medical device industry has impressed the world. China's newly developed medical devices are on the cutting edge of the international medical device industry. In the next few years, China will overtake Japan to become the world's second largest medical equipment market.
With the rapid improvement of R&D strength of domestic enterprises and the shift of market focus from high-tech to popularization, the competitiveness of domestic products is gradually increasing, providing a rare opportunity for domestic manufacturers to expand their markets. It is foreseeable that the future development of China's medical device industry has a huge space.
In addition, in the background of the world financial crisis is becoming more and more serious, in order to resist the negative impact of the international economic environment on China, the State Council executive meeting held on November 5, 2008, put forward the implementation of a proactive fiscal policy and moderately loose monetary policy, the introduction of ten more powerful measures to expand domestic demand. 2008, November 23, the Ministry of Health issued a circular in the country's new 100 billion yuan central investment arrangement, arrange special investment of 4.8 billion yuan to support the construction of rural health service system. "The 4.8 billion yuan of new investment in 2008 added 1.5 billion yuan of investment in rural medical equipment, plus 6.771 billion yuan of new investment in rural medical equipment in 2006, totaling 8.271 billion yuan of incremental investment in the two parts of the plan. This incremental 8.271 billion is mainly invested in rural medical equipment procurement, time is mainly concentrated in 2008-2010. Low-end medical equipment will face huge demand, become the first to benefit from the industry.