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Shanghai, April 11 (xinhua) -- the development and production of medical devices in China will also be Shared in the era of sharing economy. Following the Shanghai free trade zone exploration launch the registrant system innovation after the reform of medical equipment, the most innovative medical devices industry service platform 11 first settled in Shanghai, is expected to officially built in golden autumn season.
This is a third-party service platform, including CDMO(r&d and production outsourcing organization)+ CRO(clinical research organization). Such platforms have rarely been reported.
It is understood that the medical device industry service platform will provide "one-stop" work style, the whole process of services, including production line construction, technology development, sample production, performance verification, clinical evaluation, and other links, the power of medical equipment enterprises reduce the cycle of the product at the same time, reduce capital takes up, avoid the risk of trial and error. At the same time, the platform will also save social resources and solve the problem of small scattered problems in medical device industry, so as to facilitate supervision and control by the competent department.
Held on the same day "registrant of medical equipment system and civilian battalion hospital institution b policy interpretation for examination and approval of large equipment peak BBS", the reporter understands, at present, medical equipment industry has become a global trade, the most active and fastest growing per capita output value and profit margins are one of the forefront of industry.
China has become the world's second-largest market for medical devices after the United States. Compared with other manufacturing industries, the medical device industry is more innovative and faster. Although the overall development of China's medical device industry is relatively fast, there is still a huge space for development compared with the developed countries.
Wide medicine baiyun mountain international medical equipment innovation park, chairman of this image, in the past, scientific research personnel to realize achievement transformation, must want to open a factory first, when the boss, the transformation of scientific research will retard. This launch a service platform to the client for medical devices group chairman zhang told reporters that under the current system, product research and development to medical equipment product conversion process, in addition to the development of a patent, class II and III medical devices products listed takes three to eight years, invested RMB 10 million to 100 million.
According to understand, in view of the shortcomings, in December last year, Shanghai free trade zone pilot medical apparatus and instruments registrant system, broke the previous China medical device registration and production two link by "bundling" mode.
System after the "decoupling", through the whole medical devices industry service platform, holding medical instrument patent technology researchers can quickly access for medical devices industry, such as quickly form a pattern of high value, low energy consumption industry, medical equipment production and ensuring the rational allocation of resources or; The platform will also accelerate the transformation of scientific research, accelerate the introduction of foreign advanced medical devices, and gather high-tech talents.
Zhang feng said that after the completion of the medical device, the whole industry service platform is about 20,000 square meters, which can serve about 100 medical device products. Zhang calculated brushstroke zhang for journalists, Chinese New Year II and class III medical devices about more than 2000 companies, from plant construction to get a product registration certificate, plant utilization rate is not more than 5%, idle resources about 50 billion yuan. Such resource waste will be avoided in the future. At the scene, 10 medical device enterprises signed the platform agreement and 10 platform service providers signed the platform cooperation agreement.
Zhang, according to the medical device industry service platform will be committed to become China's high performance medical devices to gather, national medical equipment industry gathering area, and win the international medical equipment industry base.
On the same day, some 400 people from industry experts, well-known enterprises, scientific research institutions, government departments and industrial capital representatives of the Chinese academy of engineering attended BBS. The relevant leaders of the food and drug administration and related industry experts have made a professional interpretation of the registration system policy.
It is understood that after the success of the Shanghai innovation units will be pushed to the nation, will greatly stimulate the potential of scientific research personnel, the development of more innovation of medical equipment products, will also activate scientific research market, conducive to the development of enterprise and industry.