ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals – Labelling Requirements v2.0 Category Supplementary Resource Organisation TGA Type Standard Version 2 Access Open Status Active Created Sep-21 Updated Feb-23 This document describes mandatory labelling requirements for biologicals and human cell and tissue (HCT) materials specifically for manufacturers, sponsors and providers of these materials, and should be read in conjunction with TGO 107.
Australian Regulatory Guidelines for Medical Devices (ARGMD) Category Guidance Document Organisation TGA Type Standard Access Open Status Active Updated Nov-23 This guidance provides information on the import, export and supply of medical devices within Australia.
Digital tools and medical devices v1.0 Category Guidance Document Organisation TGA Type Standard Version 1 Access Open Status Active Updated May-23 This document provides guidance for the mental health sector about when their digital tools, aids, apps and products, including internet-based services, may be regulated as medical devices by the TGA.
Electronic Instructions for Use – eIFU v1.0 Category Guidance Document Organisation TGA Type Standard Version 1 Access Open Status Active Created Aug-18 This guideline aims to support manufacturers and sponsors who supply instructions for use of their medical devices in an electronic or online format.
How to submit a custom-made medical device / patient-matched medical device notification v2.0 Category Guidance Document Organisation TGA Type Standard Version 2 Access Open Status Active Updated Dec-23 This document describes how to complete and submit custom-made medical device and patient-matched medical device transition notifications.
Medical device cyber security information for users v1.2 Category Guidance Document Organisation TGA Type Standard Version 1.2 Access Open Status Active Updated Nov-22 This document describes cyber security practices and protocols for the medical device sector and aims to help medical device users manage cyber security risk.
Medical device patient information leaflets and implant cards (including acceptance of Implementation Plans) v1.9 Category Guidance Document Organisation TGA Type Standard Version 1.9 Access Open Status Active Created Oct-22 Updated May-23 This document aims to help manufacturers and sponsors understand the legislative requirements for patient information materials, such as patient implant cards and patient information leaflets, and how to comply with these requirements.
Medical device patient information materials: a fact sheet for health professionals Category Supplementary Resource Organisation TGA Type Standard Access Open Status Active Updated May-23 This fact sheet for health professionals discusses providing patients with information about their medical devices. It discusses who is responsible for providing patient information leaflets (PILs) and patient implant cards (PICs) to patients, and when they should be supplied.
Medicine labels: Guidance on TGO 91 and TGO 92 v2.3 Category Supplementary Resource Organisation TGA Type Standard Version 2.3 Access Open Status Active Created Mar-21 This document provides extensive guidance for medicine labelling rules TGO 91 and TGO 92. It clarifies and elaborates on the mandatory requirements and provides best practice recommendations for medicine labels.
Regulation of software based medical devices Category Guidance Document Organisation TGA Type Standard Access Open Status Active Updated Jul-24 This document provides information on the regulation in Australia for software and apps which meet the legislated definition of a medical device. It helps manufacturers and sponsors understand how the Therapeutic Goods Administration (TGA) interprets requirements, and how they can comply with the regulations.
Regulatory basics on medical devices for health practitioners v1.0 Category Guidance Document Organisation TGA Type Standard Version V 1.0 Access Open Status Active Created Mar-24 This guidance is for Australian health practitioners who manufacture, supply and use medical devices. It helps them identify whether their devices are regulated by the Therapeutic Goods Administration (TGA) and it also advises how to comply with the requirements of the therapeutic goods legislation.
Standard for serialisation and data matrix codes on medicines v1.0 Category Supplementary Resource Organisation TGA Type Standard Version V 1.0 Access Open Status Active Created Mar-21 This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in the Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021.
Therapeutic Goods (Medicines-Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 Category Standard Organisation TGA ID F2021L00333 Type Standard Access Open Status Active Created Mar-21 This document is the standard for serialisation and data matrix code use in relation to medicines.
Therapeutic Goods (Standard for Biologicals-Labelling Requirements) (TGO 107) Order 2021 Category Standard Organisation TGA ID F2021L01325 Type Standard Access Open Status Active Created Sep-21 This document sets out the labelling requirements for biologicals and human cell and tissue materials.
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines Category Standard Organisation TGA ID F2023C00458 (C03) Type Standard Access Open Status Active Created Apr-23 This document sets out the labelling requirements for prescription medicines and composite packs containing a subscription medicine. It includes general labelling requirements, information that must be present, information that must be on the main label, and exemptions from the labelling requirements.
Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines vC02 Category Standard Organisation TGA ID F2023C00456 (C02) Type Standard Version C02 Access Open Status Active Created Apr-23 This document sets out the labelling requirements for non-prescription medicines. It includes general labelling requirements, information that must be present, information that must be on the main label, and exemptions from the labelling requirements.