List of Regulatory Standards and Websites for IVD (In Vitro Diagnostic Reagents/Devices) and MD (Medical Devices) in China, Europe, and the USA
Core Principles: Official Priority: The official websites of the regulatory authorities for drugs and medical devices in various countries/regions (NMPA, EC/EU, FDA) are the most authoritative sources for obtaining original regulations, guidelines, databases, and the latest updates. Standards Organizations: International standards organizations (ISO, IEC) and national standard organizations (such as SAC in China, ANSI in … Read more