Guidance

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.

Guidance for sponsors and manufacturers to meet the technical, scientific and regulatory requirements to ensure the quality of probiotic medicine acceptable under the Therapeutic Goods Act 1989

This guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

This guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.

Guidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.

Guidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.

Guidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Guidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Manufacturers are responsible for maintaining evidence that their devices comply with the Essential Principles.

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.

Assists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

Guidance to assist sponsors to understand the process for submitting a priority registration application.

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Guidance on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.

Guidance on when and how to provide Product Information to us.

Guidance on the evaluation process and information required for new registered complementary medicines.

Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.