Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, has published detailed guidance describing the documentation to be submitted by the applicant in the context of inclusion of a medical device to the...
Canada
Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance dedicated to the licenses an entity shall obtain to be allowed to perform certain regulated activities. In...
Europe
Last Wednesday, as part of our monthly #WebinarWednesday series, RegDesk hosted an immensely informative presentation about recent changes to medical device regulations in the Eurasian Union. This month’s featured speaker, Eurasian regulatory expert Alexey...
Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. The present article describes the...
Europe
The Bosnia and Herzegovina Agency for Medicines and Medical Devices, the country’s regulating authority in the sphere of healthcare products, has published a user guide dedicated to the national information system for medical devices. General Information About...
Uncategorized
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published guidance dedicated to the labeling requirements medical devices should comply with in order to be allowed for marketing and use. Regulatory...
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