The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for medical devices, announced the reduction of annual charges for medical devices listed on the prostheses list. Prostheses Medical Devices: Regulatory Background According...
The Food and Drug Administration (FDA) issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden reduction systems. The document describes special extraordinary measures...
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 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...
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical devices regulation, issued guidelines describing how medical device manufacturers shall apply for inclusion of the COVID-19 test in the national register of medicinal products...