The National Agency for the Safety of Medicines and Health Products (L’Agence nationale de sécurité du médicament et des produits de santé or ANSM) is the French government agency with jurisdiction over pharmaceuticals, biological products, medical devices, and cosmetics. Created by the Act of 1 July 1998, the ANSM functions under the Ministry of Health and has the authority to monitor and regulate health products.
It superseded the AFSSAPS (l’Agence française de sécurité sanitaire du médicament et des produits de santé) on May 1st, 2012 and received a broader authority to monitor and evaluate health products, as well as a greater budget. The ANSM also actively participates in standardizing and harmonizing regulation and practices on the European market.
A list of EU regulations can be found here on our website.
Contact details:
Medical Device Associations in France:
我们的专家将详细解读2023年韩国食品药品安全部(MFDS)指导文件草案更新下韩国医疗器械注册监管要求、分类标准、韩国良好生产规范(KGMP)等相关要求,并将依据多年韩国本地注册经验提供注册案例分享。此外,您还将了解到制造商在面对MFDS监管时需要关注的核心要点,相关研讨会内容包括:
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