Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has published a new guidance document titled “Guideline for Preparation of a Site Master File (SMF) for Wholesalers of Medical Devices”. The guideline provides requirements for medical device wholesalers preparing a Site Master File (SMF) as part of medical device establishment licence applications in South Africa. The guidance applies to wholesalers of medical devices, including In Vitro Diagnostic medical devic

The Australian Therapeutic Goods Administration (TGA) has updated its guidance on the implementation of the Unique Device Identification (UDI) system for medical devices supplied in Australia. The guidance, Complying with the Unique Device Identification Timeframes for Medical Devices, Version 2.0, published in May 2026, explains the phased UDI compliance timelines, sponsor responsibilities, transitional arrangements, and direct marking obligations for medical devices and IVD