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...
COVID-19
The Food and Drug Administration (FDA or the Agency) issued detailed guidelines dedicated to adverse event reporting rules for medical devices placed on the market under the Emergency Use Authorization (EUA). The EUA is a special regulatory framework implemented by...
The Medical Device Coordination Group (MDCG), an advisory body composed of representatives of all Member States who are focused on the improvement of the existing regulatory framework, recently issued guidance dedicated to medical devices containing ancillary...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on 3D printing of medical devices and components in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). Scope of the MHRA Guidance The present guidance published by...
Europe
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...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), Saudi Arabia`s authority for medical devices regulation, issued guidance dedicated to the field safety corrective actions. Regulatory Background The present SFDA guidance is intended to provide additional information and...
