MHRA Regulatory Advice Meetings: Updated Guidance for Medical Device Manufacturers
The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.
TGA Updates Guidance on Essential Principles for Medical Device Safety and Performance
The TGA has released an updated consolidated guidance on the Essential Principles for medical devices, outlining key regulatory, safety, and performance requirements manufacturers must meet to supply devices in Australia. This update strengthens expectations for risk management, clinical evidence, design and manufacturing controls, and technical documentation, reinforcing compliance obligations for medical device manufacturers targeting the Australian market.
FDA publica uma proposta de orientação sobre requisitos de UDI para produtos combinados
O novo guia preliminar da FDA sobre UDI em produtos combinados descreve requisitos detalhados para a rotulagem, identificação e submissão ao GUDID. Esta orientação afeta fabricantes de dispositivos médicos e medicamentos combinados, que deverão avaliar se os seus produtos requerem UDI, NDC ou ambos, conforme o tipo de componente principal.