The Colombia National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) is regulatory authority created in 1992 under the Ministry of Health. INVIMA is in charge of inspecting and supervising the marketing and manufacturing of health products, identifying and evaluating the violation of health standards or procedures, and implementing best practices and providing medical approval for the import and export of products.
The entity within INVIMA that deals with medical device matters is the Directorate for Medical Devices and other Technologies (Dirección de Dispositivos Médicos y Otras Tecnologias), subordinated directly to the General Directorate. The directorate monitors and controls medical devices, tracks pre- and post-market programs and, among others, suggests technical standards for the manufacturing, marketing, surveillance, and quality assurance of devices.
A list of INVIMA regulations can be found here on our website.
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:
阅读更多请参考下列加拿大卫生部对外公布的PDF文件。 关于医疗器械法规的链接 加拿大卫生部——
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