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China Update: Announcement No. 124 of 2022; Draft Guidelines for the Registration of Implantable Medical Devices
Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries
IVDR Update: European MDCG Issues Guidance on Substantial Modification of a Performance Study
An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.