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Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria.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...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
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 design control in the context of medical devices. Among other matters, the document addresses aspects...
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