FDA
The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the Food and Drug Administration (FDA or the Agency), the US regulating authority, earlier in 1989. Since that time, the document has been...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the investigation of reported problems associated with medical devices. The latest version of the document...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a detailed guidance document dedicated to the process of inclusion of medical devices in the Australian Therapeutic Goods Register, 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 the medical device reporting requirements for manufacturers. The document provides an overview of the key...
Canada
In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most significant changes discussed were new requirements related to foreign risk...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to completing the application for a new medical device license or medical device license amendment for a private label medical device....
