Europe
The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, announced amendments to the MDDT framework. Medical Device Development Tools (MDDT) The Agency published a notice dedicated to certain amendments made to...
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
Europe
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...
