Reclassification of Medical Equipment in Australia
TGA Regulation: Key Steps for Class III Medical Devices Compliance This article discusses about the TGA Regulation the transitional steps that sponsors of medical devices intended to be used in direct contact with the heart and central circulatory system must do in order to be in compliance with new laws and regulatory criteria starting on […]
New Framework to Manufacture Innovative Medicines in the UK
What is the New UK Point of Care Regulatory Framework? This article is about the EU MDR Regulation – Medicines and Healthcare Products Regulatory Agency (MHRA) announcing that the UK will be the first country to introduce a tailored framework for the regulation of innovative patient care products. As per EU MDR Regulation – This […]