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South Africa SAHPRA Med. Dev Guideline: Site Master File (SMF) Requirements for Medical Device Wholesalers
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
Sharan Murugan
1 hour ago3 min read
TGA Med. Dev Guidance: Unique Device Identification (UDI) Compliance for Medical Devices in Australia
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
Sharan Murugan
1 hour ago3 min read
Ireland's HPRA Guidance: GDP Quality Systems, GXP Regulatory Advice, and Active Substance Registration Changes
The Health Products Regulatory Authority (HPRA) has released updated guidance documents to strengthen pharmaceutical quality systems, regulatory compliance, and operational oversight across Ireland’s healthcare sector. The updated guidance documents include: Guide to Quality System for General Sale Wholesale Distributors Guide to Pre-submission Scientific and Regulatory Advice for GXP Activities Guide to Managing Changes to Registrations of Active Substance Manufacturers, Imp
Sharan Murugan
2 hours ago3 min read