To ensure the sustainable development of innovative technologies, the International Medical Device Regulatory Forum (IMDRF) has developed a special framework for software with the intended medical purpose. Three guidance documents dedicated to terminology, risk-based...
The Roszdravnadzor, the Russian federal authority responsible for medical devices regulation, issued recommendations on quality, effectiveness, and safety examination of medical software for the purpose of state registration under the national framework. Eligibility...
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...
Australia’s Department of Health has published the first set of amendments to the Therapeutic Goods (Medical Devices) Regulations in the course of amending the medical device framework. This framework was developed on the basis of information collected through public...
Health Canada, the Canadian medical device regulating agency, has issued new guidance on software as a medical device (SaMD) to provide details on definition and classification. The Scope of the Guidance The new guidance describes certain aspects of the...