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Australia TGA Guidance: UDI for Medical Devices and OTC Medicine Application Requirements
Australia’s Therapeutic Goods Administration (TGA) continues to strengthen regulatory clarity through updated guidance documents covering medical devices and over-the-counter (OTC) medicines. Guidance: Complying with Unique Device Identification requirements for medical devices – TGA The TGA’s guidance on Unique Device Identification (UDI) requirements outlines the regulatory framework for assigning and maintaining UDIs for medical devices supplied in Australia. The UDI sy
Sharan Murugan
Feb 212 min read
Australia TGA: Reporting of Medical Device adverse events by Healthcare Facilities
Post-market vigilance is a critical component of medical device regulation. While pre-market assessment ensures that devices meet essential safety and performance requirements before approval, real-world use can reveal risks that were not apparent during clinical evaluation. Recognising this, the Therapeutic Goods Administration (TGA) has introduced structured requirements for healthcare facilities to report medical device adverse events. The guidance titled “Reporting medic
Sharan Murugan
Feb 153 min read
TGA Guidance: GMP Update for Medicinal Products in Australia: Transitioning to PIC/S Guide PE009-17
Good Manufacturing Practice (GMP) serves as the backbone of pharmaceutical quality assurance. It ensures that medicinal products are...
Sharan Murugan
Aug 28, 20252 min read
Australia TGA's Guidance: Regulatory Landscape for Personalised Medical Devices and Companion Diagnostics
As the healthcare industry continues to evolve, the integration of personalised medical devices and companion diagnostics has become...
Sharan Murugan
May 24, 20253 min read
Australia's TGA Guidance Blog: Labelling and Presentation Requirements for Listed Medicines
On 9 April 2025, the Therapeutic Goods Administration (TGA) released updated guidance titled “ Understanding Labelling and Presentation...
Sharan Murugan
Apr 23, 20253 min read
Australia (TGA) Med Dev User Guide: Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles
The Therapeutic Goods Administration (TGA) has released Version 3.0 of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
Mar 21, 20252 min read
TGA Guidance: Consent for Non-Compliant Medical Devices that do not meet the Essential Principles
The Therapeutic Goods Administration (TGA) has released updated guidance in "Completing an application for consent to import, supply, or...
Sharan Murugan
Mar 11, 20252 min read
TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...
Sharan Murugan
Dec 15, 20242 min read
Australia's TGA: Listed Medicines Evidence Guidelines
Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA) released Version 4.0 of its Listed Medicines " Evidence...
Sharan Murugan
Nov 20, 20242 min read
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...
Sharan Murugan
Jul 29, 20242 min read
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...
Sharan Murugan
Jul 13, 20242 min read
TGA Guidance: Regulatory Changes for Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...
Sharan Murugan
Jul 6, 20242 min read
TGA Guidance: Regulatory Obligations for Exempt Medical Devices
The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt...
Sharan Murugan
Jun 23, 20242 min read
Australia TGA: Regulation of Software based Medical Devices
On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...
Sharan Murugan
May 14, 20242 min read
Australia TGA: Regulatory requirements for in-house IVDs
Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...
Sharan Murugan
May 1, 20242 min read
Australia TGA: Clinical Trial Notification (CTN) Form - User Guide
On 28th March, 2024 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "Clinical Trial Notification...
Sharan Murugan
Mar 30, 20241 min read
TGA MD Guidance: Medical Device Labelling Obligations
On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device...
Sharan Murugan
Feb 22, 20241 min read
Australia TGA: eCTD AU module 1 and regional information
Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...
Sharan Murugan
Jan 31, 20241 min read
Australia TGA: Clinical Evidence Guidelines
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...
Sharan Murugan
Nov 26, 20232 min read
TGA Guidance: General Dossier Requirements
Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...
Sharan Murugan
Oct 31, 20231 min read