Since October 1, "Medical Device Registration", "in vitro diagnostic reagents Registration" and other five rules came into effect. At the same time, the State Health Planning Commission announced October 9, grading treatment system is drafting the relevant documents, will gradually establish conditions for the current grading system for diagnosis and treatment, the provinces select at least one public hospital reform pilot city pioneered medical classification system, this policy the introduction into the primary health care sector makes equipment procurement phase. Insiders pointed out that a lot of favorable policies to usher in the medical device industry, will enter a phase of rapid development.

　　Frequent medical device industry policy

　　Reporters learned from the State Drug Administration of food, "Medical Device Registration", "in vitro diagnostic reagents Registration", "medical device specification and labeling regulations," "Production Supervision and Administration of Medical Devices", "medical equipment business supervision management approach "five regulations on October 1 this year, came into effect.

　　In addition to these five rules, the new version of "Medical Devices Regulations" began implementation of June 1, 2014. The new regulations increase the punishment for the first time, for unauthorized production and management of behavior, to a maximum value of 20 times the amount of fines. Industry analysts believe that the implementation of the new "Regulations", intended to "establish the most stringent regulatory system covering the whole process of" regulatory high-risk medical devices will further tighter.

　　"Medical device industry for many years without a new policy, and this policy can be described as medical devices Danian." China Association for Medical Devices medical supplies Branch Secretary Hongyan Chen said that such "Medical Devices Regulations" was enacted in 2000, has now been 14 years of practice, and there is no way to make any modifications to the regulations, but our equipment industry has undergone enormous changes in these 14 years has occurred.

　　Secretary-General of Nutrition and Health Industry Association, Guangdong Province, Zhang Yong believes that this amendment clarifies that medical devices "first product registration, post-production license" regulatory model, provides producers in medical device product registration card case, you can apply medical equipment production license. Change this regulatory approach, reducing the corporate funding of early pressure, and further demand the release of industry innovation, encourage emergence of innovative enterprises.

　　In addition, in February this year, the General Administration of Food and Drug Administration has issued a "special innovative medical device approval process" on the instrument innovation encouraged. The policy referred to the relevant regulatory authorities to ensure that the listed product safety, under the premise of effective, innovative medical devices for special approval to set the channel and accelerate speed to market. The policy of encouraging research and innovative medical devices, medical devices promote the popularization and application of new technologies to promote industrial development of medical devices play a positive role.

　　Adds pilot clinics spread good grade

　　Shortly after the National Day holiday, the medical device industry has spread the good news. October 9, the State Planning Commission announced that it was drafting health clinics grading system related documents, will gradually establish conditions for the current grading system for diagnosis and treatment, the provinces select at least one public hospital reform pilot city pioneered medical classification system.

　　The so-called medical classification is in accordance with the light of the disease, heavy, slow, ease of grading and treatment of acute, medical institutions at different levels of commitment to the treatment of different diseases, their own strengths, the progressive realization of specialization, the medium-sized hospitals bear general outpatient, rehabilitation and nursing triage to primary health care sector, a "health into the family, a minor illness at the grassroots level, serious illness to hospitals, rehabilitation back to the grass roots" pattern.

　　Currently, Qinghai, Jiangsu, Zhejiang, Sichuan and other provinces, for different levels of medical institutions, the implementation of differentiated fees and insurance reimbursement criteria, and gradually widening the gap, to guide patient treatment diversion. Recently, Beijing, Shanghai, Ningxia, Chongqing and other places are also relevant policy documents, making institutional arrangements for grading clinics. National Planning Commission spokesman David Song Shuli said the state Health Planning Commission is sorting, grading summarize exploration experience throughout the reconstruction treatment system, research clinics drafting national classification system related files.

　　It is understood that China currently has more than the county hospital 13000, township (town) hospitals 52,000 hospital beds more than 300 million copies of primary health care sector is much higher than in the hospital clinic visits, but with the level of medical equipment low, the device is more obsolescence. With the implementation of the pilot and the grading system of clinics, primary health care institutions will enter the procurement of equipment, medical equipment and consumer markets will subsequently be further expanded.

　　Domestic medical device companies are expected to rise

　　It is understood that a long time, a large public hospital medical equipment market has been monopolized by foreign and domestic medical equipment and even county-level hospitals are difficult to enter, private hospitals have become the domestic large medical equipment "last straw."

　　In March of this year, China Resources Wandong Medical Devices business exit announcement. Industry analysts believe that China Resources Group to opt out of the medical device industry is not surprising, because the Chinese market is basically monopolized by foreign businesses. Medical equipment market in the country, foreign investment and joint ventures become the main force, imported products in China has been a sales monopoly. Among them, General Electric, Philips and Siemens three companies account for most of the high-end market, conservatively estimated to have exceeded 70%.

　　Faced with this situation, the evening of May 26, the first domestic satellite launch Planning rushed medical equipment selection, and select digital X-ray machine, color Doppler ultrasonic diagnostic apparatus and automatic biochemical analyzer three kinds of basic medical equipment the first selection of items, which gives domestic medical device industry a positive signal. State Securities research reports that selected catalog is expected to become the benchmark domestic equipment market by accelerating the process of dividend policy, and ultimately reduce health care costs through import substitution.

　　August 16, the State Planning Commission and the Ministry of Health held a joint application to promote the development of domestic medical device conference. Wei Bin, director of the State Planning Commission, said it will focus on promoting the three hospitals with domestic medical equipment. Minister of Industry and Miao Wei said that in order to promote the development of domestic industry, medical equipment, will take the initiative to establish the use of domestic medical equipment incentives.

　　September 28 to 29, the State Planning Commission, budget management Methodist Hospital construction work will be held in Shanghai, 44 major hospitals budget management committee responsible person in charge of the President and the Director of infrastructure work to attend the meeting. According to media sources, the State Planning Commission deputy director Wei, director of the State Department Office of Sun Zhigang medical reform mentioned Methodist Hospital Annual Planning arrange these central infrastructure investment, it will reduce the proportion of drugs, speeding up the construction of information technology to improve the proportion of domestic equipment and other relevant policies and the implementation of health care reform as an important factor.

"Under the new industry policy background, has the advantage of brand and medical equipment financing company is expected to seize the initiative." Analysts pointed out that, in recent years, the market scale expansion of China's medical device industry rapidly, however, the entire medical device industry is still faced with small, scattered, chaotic, and many other problems. About 90% of the medical equipment manufacturing enterprises, the annual income hovers around a thousand million, low-tech production. Future medical device market demand will be further enhanced, increasing the size of the industry, which will greatly benefit with independent intellectual property rights and core competitive advantages of the domestic leader in the enterprise to achieve sustained and rapid development.

　　Official statistics show that between 2001-2013, the market size of the medical device industry breakthrough from 17.9 billion yuan to 200 billion yuan, an increase of more than 11 times. KPMG in May 2013 related to the report predicts that by 2015, China will become the world's second largest consumer market in medical devices.