Tag: Medical device labelling requirements

Regulatory Changes for Software Based Medical Devices in Australia

August 20, 2021
Medical Device

The Therapeutic Goods Administration (TGA) regulates software-based medical devices; including software that functions as a medical device in its own right, and software that controls or interacts...

Medical device labelling requirements, regulatory guidance, Software as a Medical Device, Software Based Medical Devices in Australia, Therapeutic Goods Administration (TGA)

Medical Devices – Regulatory Updates – August Volume 2

August 19, 2021
Medical Device

EUROPE 1.Guidance for industry on MHRA’s expectations for return to UK on-site inspections In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based...

EU Medical Device Labelling, Europe medical devices regulatory updates, India dgft regulatory updates, Medical device labelling requirements, Medical Devices Regulatory Updates, Regulatory Updates August Volume 2, us medical devices regulatory updates