Various policies encourage medical devices to accelerate the pace of innovation
both the development situation of the domestic medical device industry and the current development situation of the global medical device industry show that only by strengthening innovation can current medical device enterprises obtain living space in the future medical device market, and being content with the current situation will gradually be eliminated by the market
in order to encourage the research and innovation of medical devices, in March this year, the national food and Drug Administration issued the "innovative medical devices, which is a special approval procedure after receiving simulated electrical signals" and the "provisions on simplifying the re registration application materials of medical devices", and said that in the future, priority will be given to the approval of innovative medical devices and a green channel will be opened
according to relevant policies, innovative medical devices will be given priority. However, the declared product must have the independent intellectual property rights of the core technology of the product. The main mechanism of the new SLA material to expand market opportunities is domestic initiative, the product performance or safety is fundamentally improved compared with similar products, the technology is at the international leading level, and has significant clinical application value
some experts said that the definition and theme of innovation should be further clarified in the medical device regulations, and domestic innovation, world innovation and emergency innovation should be distinguished. In terms of approval process and supervision mode, different regulations should also be formulated according to the different characteristics of domestic innovation, world innovation and emergency innovation
for innovative medical devices, food and drug supervision and administration departments at all levels and relevant technical institutions will carry out approval under the premise of no reduction in standards and procedures in accordance with the principles of early intervention, special person responsibility and scientific approval. Various requirements show China's confidence in promoting the innovation and development of medical devices
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