医疗器械跨境转移生产的上市许可研究

      Research on Marketing Permission of Cross-border Transfer Production of Medical Devices

      • 摘要: 当前,境外注册申请人希望将已获准进口注册的产品转移至我国境内生产的呼声越来越强烈,如何面对该事项并妥善处理,值得我们监管部门研究。该研究首先系统梳理FDA、欧盟、日本对生产地址变更的规定要求;其次,简要梳理分析我国当前对国产和进口器械的监管差异;最后,参照国外的经验做法,结合我国实际,对如何满足境外注册人将产品转移至我国境内生产提出意见建议。

         

        Abstract: At present, there is a growing call for overseas registration applicants to transfer the products that have been approved for import registration to China's domestic production. It deserves our regulatory authorities to study how to face and properly deal with this issue. First of all, this paper systematically combs the regulatory requirements of FDA, EU and Japan on the change of manufacturing site address. Secondly, the paper briefly analyzes the current regulatory differences between domestic and imported devices. Finally, according to the experience and practice of foreign countries, combined with the actual situation of our country, this paper puts forward suggestions on how to meet the needs of overseas registrants to transfer products to domestic production.

         

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