Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper dedicated to the proposed refinements to the regulation of personalized medical devices. Table of Contents...
Australia and Oceania
Australia’s Therapeutic Goods Administration (TGA), the national authority responsible for medical devices regulation, announced that the consultation period for the proposed regulatory framework for the software-based medical products ends on May 13, 2020. The...
EU MDR/IVDR
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to provide assistance to regulating authorities and...
North America
For two months, Health Canada will open a public consultation on its guidance about promotional ads for health products, such as medical devices and drugs. They want to protect the public by helping to distinguish a promotional message from educational content, and so...
