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...
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....
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...
Canada
Health Canada, a Canadian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to inspections of medical device establishments. The current version of the document was published in November 2016 and replaced the...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
