Sun Xue, Han Qianqian
National Institutes for Food and Drug Control, Beijing, 102629.
Zhongguo Yi Liao Qi Xie Za Zhi. 2021 Nov 30;45(6):591-593. doi: 10.3969/j.issn.1671-7104.2021.06.001.
This study summarizes the status of domestic industries of medical devices for assisted reproductive technology, product category, the status of product classification management, the status of technical review, the progress of quality evaluation technology, and the progress of standardization. The domestic industry of medical devices for assisted reproductive technology in my country has begun to take shape, and a solid foundation has been laid for standardization and supervision technology. These will become an important driving force and guarantee for the subsequent development of medical devices for assisted reproductive technology. Under the guidance of the new development concept and the trend of accelerating the construction of the main body of the domestic cycle, my country's independent and controllable assisted reproductive medical device industry is gaining momentum.
本研究总结了我国辅助生殖技术医疗器械产业现状、产品类别、产品分类管理状况、技术审评状况、质量评价技术进展以及标准化进展。我国辅助生殖技术医疗器械产业已初步形成，为标准化和监管技术奠定了坚实基础。这些将成为辅助生殖技术医疗器械后续发展的重要驱动力和保障。在新发展理念指引和加快构建国内大循环主体趋势下，我国自主可控的辅助生殖医疗器械产业正蓬勃发展。
