Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to inspections of medical device establishments. The document outlines the main principles of inspections to be carried...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to the suggested regulatory approach with regard to the nanomaterials used in medical devices. The document...
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...
EU MDR/IVDR
The United Kingdom has adopted a final version of a regulatory framework for medical devices to be in force after Brexit. The new legislation prescribes the approaches to be applied with regard to the regulatory procedures associated with placing medical devices on...
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published the updated rules for evaluation of the software intended to be used for medical purposes. The document initially issued on February 12, 2021, and named “The...
