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.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
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