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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
7 days ago3 min read
Swissmedic Guidelines: Formal Requirements & GMP Compliance for Foreign Manufacturers
When navigating Switzerland's regulatory landscape for medicinal products, two key guidance documents from Swissmedic stand out for their...
Sharan Murugan
May 3, 20253 min read
USFDA Guidance: Considerations for Complying with 21 CFR 211.110
The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...
Sharan Murugan
Jan 6, 20252 min read
Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...
Sharan Murugan
Apr 22, 20242 min read