Medical device safety is directly related to the people's health and life safety. The newly revised Regulations for the Supervision and Administration of Medical Devices have been promulgated and will come into force on June 1, which is a major event in the modernization process of China's medical device supervision. Below I have compiled the answers to the "supervision and management regulations of medical devices", I hope to help you!
"Medical Device Supervision and Administration Regulations" answer one: encourage and promote medical device innovation
Innovation is the inexhaustible power of the country, national development and progress. The process of development of the modern world shows that major original scientific and technological innovation and its triggered by the industrial technology revolution often make human life and social outlook epoch-making changes. Countries with strong scientific and technological innovation capabilities have become the dominant players in the world's scientific and technological, economic, cultural and social development.
As an industrial field closely related to public health and life safety, medical devices cover a wide range of products, including tongue depressors, gauze and other low-value consumable products, as well as high-tech and high-priced equipment such as multi-row CT, PET-CT, superconducting magnetic **** vibration, proton gas pedal. At present, China's conventional medical devices have basically realized independent production, high-end medical devices have also been involved, but the situation dominated by low-tech content, low-tech level of low- and medium-grade products has not changed. As of 2013, the country **** has nearly 16,000 medical enviromental equipment manufacturers, of which the third class medical equipment manufacturers accounted for about 17%, the second class medical equipment manufacturers accounted for about 54%, the first class medical equipment manufacturers accounted for about 29%. This shows that China's medical device industry, the production of high technology content of the third class of medical devices in the enterprise is relatively small, the innovation ability needs to be improved.
The newly revised Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as "Regulations") will come into force on June 1st. The general provisions of the Regulations clearly state that the state encourages medical device research and innovation, promotes the promotion and application of new medical device technologies, and promotes the development of the medical device industry. Regulations from the optimization of review and approval, reduce the burden on enterprises, encourage innovation and other perspectives for a series of specific system design, to promote the development of the medical device industry, to encourage enterprises to become bigger and stronger to provide a strong legal basis and policy basis.