ARQonMar 6, 20231 minEU: Substantial Modification of Performance Study Under Regulation (EU) 2017/746 A guideline paper titled MDCG 2022-20 - Substantial Modification of Performance Study under the In Vitro Diagnostic Medical Devices...
ARQonMar 6, 20232 minChina: Medical Device's Compulsory Updates by NMPA1. Change Application as New Compliance-to-Maintain Requirement The National Medical Products Administration of China (NMPA) published an...
ARQonFeb 22, 20232 minUS: Industry Calls for The Flexibility in FDA’s Paediatric Measurement GuidanceA trade association for the pharmaceutical industry and a number of pharmaceutical companies urged the US Food and Drug Administration...
ARQonFeb 22, 20231 minThailand: FDA Guidelines for Software as Medical Device (SAMD)Thailand Food and Drug Administration (FDA) published guidelines to determine the state and risk categorization of medical device...