Regulatory Blog

The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...

The Medical Device Coordination Group recently updated the guidance"Standardisation for Medical Devices" include points on topics...

The swissmedic recently on 1st July, 2024 updated and shared two guidances "Guidance: Formal Requirements" and "Guidance: SwissPAR"....

FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...

The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...