新冠肺炎疫情虽使全球医疗器械市场遭遇了极大损失,但也带来了新的机遇和发展方向,促使医疗器械产业从低端向中高端转型。一方面,各公司加大在技术创新方面的投入;另一方面,智慧医疗的模式在疫情中得到了前所未有的发展。2020年国内各省(区、市)陆续开展集中带量采购,使得企业利润结构发生改变,进而推动市场结构的调整和行业的集中化。一系列医疗器械监管法规条例的发布和医疗器械唯一标识(UDI)的实施,都预示着我国对医疗器械监管制度的完善和对质量控制的强化;而注册人制度则为医疗器械公司,尤其是新进公司,带来了新的发展机会。2020年我国骨科医疗器械市场销售额达到298亿元,创伤、脊柱、关节的国产化率分别达到72%、54%和47%。随着国内企业技术日趋成熟,国产化率将进一步提升,而创新仍将是我国骨科医疗器械市场持续发展的动力源泉。
<<The sudden new crown pneumonia virus(COVID-19)at the end of 2019 caused great losses to the global medical device market,and also brought new opportunities and development directions,prompting the medical device industry to transform from low-end to mid-to-high-end. On the one hand,companies have increased their investment in technological innovation. On the other hand,the smart medical model has received unprecedented development opportunities in the epidemic. In 2020,domestic provinces have successively carried out volume-based procurement,and the profit structure has changed,thereby promoting the adjustment of the market structure and the centralization of the industry. The issuance of a series of medical device supervision regulations and the implementation of the unique identification code(UDI)for medical devices all heralds China’s improvement of medical device supervision and stricter quality control;While the registration certificate holder system brings new development opportunities for medical device companies,especially new companies. In 2020,Chinese orthopedic medical device market reached $460 million,and the localization rates of trauma,spine,and joints reached 72%,54% and 47% respectively. As the technology of domestic enterprises matures,the localization rate will further increase,and innovation is still the source of power for the sustainable development of Chinese orthopedic medical device market.
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