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...
Asia
The Directorate General of Pharmaceutical Affairs and Drug Control, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements related to the registration of high-risk medical...
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...
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to infusion pumps. The guidance highlights matters related to performance testing. It is important to...
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 infusion pumps and regulatory matters associated thereto. The document addresses the most important...
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. The document covers the regulatory matters related to design verification and...
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