Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the regulatory requirements related to the cybersecurity aspects associated with medical devices. The document...
Asia
The Pharmaceutical and Medical Devices Agency (PMDA), the Japanese medical device regulating authority, issued a Safety Information notice dedicated to the recent trends in cybersecurity assurance of medical devices. Regulatory Background According to the position of...
IMDRF
The International Medical Device Regulators Forum, a voluntary association of medical device regulating authorities focused on the improvement of the regulatory framework, issued guidance dedicated to the principles and practices for cybersecurity for medical devices....
Europe
The Medical Device Coordination Group (MDCG), an advisory body composed of the representatives of EU member states, issued guidance dedicated to cybersecurity issues. Scope of the Guidance According to the medical device regulations 745/2017 (MDR) and 746/2017...
North America
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult it is to identify vulnerabilities. The Threat...
