FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document is intended to provide...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published and questions-and-answers document dedicated to repacking and relabeling activities by the Medical Devices Regulation 2017/745...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices has published a guidance document dedicated to testing and labeling medical devices for safety in the magnetic resonance (MR) environment. The document...
Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The document is intended to provide additional clarifications regarding the applicable...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the current classification rules. The document is intended to assist medical device manufacturers...
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