The Department of Planning and Organization of the National Health Service (Il Dipartimento della programmazione e dell'ordinamento del Servizio sanitario nazionale) is the regulatory agency within the Italian Ministry of Health that deals regulating pharmaceuticals, medical devices, and other health products. According to the constitutional law n. 3 of 18 October 2001, the department develops and monitors quality assurance systems, coordinates health policies, authorizes and controls medicines, medical devices, and other health products, as well as legal medical activities.
Within it, the Directorate General for Medical Devices, Pharmaceutical Services and Safety in Healthcare (La Direzione generale dei dispositivi medici, del servizio farmaceutico e della sicurezza delle cure svolge) deals with the implementation of medical device regulations, preventing and dealing with clinical risk, regulating the advertising of medical products, and providing medical-legal consultancy to state institutions.
A list of EU regulations can be found here on our website.
Contact details:
Medical Device Associations in Italy:
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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