Australia 30, October 2025 — The Australian Therapeutic Goods Administration (TGA) has issued a pivotal update to its regulatory framework with the release of the “Therapeutic Goods (Medical Devices Information that Must Accompany Application for Inclusion) Amendment Determination 2025.” This amendment, effective 1 December 2025, introduces key changes that broaden the scope of acceptable documentation for medical device inclusion in the Australian Register of Therapeutic Goods (ARTG). This legislative update reflects Australia’s move towards more harmonized global regulatory standards particularly with the UK and MDSAP regions and is expected to significantly ease the path to market for international manufacturers.
KEY HIGHLIGHTS OF THE TGA AMENDMENT 2025
UK Certifications Now Accepted
In a major shift, the amendment recognizes documentation issued under the following UK Directives:
- Directive 90/385/EEC – Active Implantable Medical Devices (AIMD)
- Directive 93/42/EEC – General Medical Devices (MDD)
- Directive 98/79/EC – In Vitro Diagnostic Devices (IVDD)
Manufacturers can now submit certificates issued by UK Approved Bodies under these directives when applying to include their devices in the ARTG. This change is particularly helpful for manufacturers still transitioning from EU CE Marking to MDR/IVDR compliance or focusing on the UK post-Brexit.
MDSAP Audit Scope Expanded
The update also replaces the term “recognised auditing organisation” with “recognised or authorised auditing organisation,” officially expanding eligibility to MDSAP-authorised bodies. Participating regulators include:
- Australia’s TGA
- US FDA
- Health Canada
- Brazil’s ANVISA
- Japan’s MHLW and PMDA
This creates smoother pathways for companies operating across these jurisdictions.
Support for FDA-Exempt Devices
Another progressive update: the amendment allows manufacturers of 510(k)-exempt devices in the US to submit a statement of exemption (including device name, regulation number, and submission type) in lieu of a full technical file. This reduces documentation burden while maintaining regulatory oversight.
TECHNICAL REQUIREMENTS – WHAT HAS CHANGED?
Depending on the device type (e.g. sterile, non-sterile, with measuring function), the amendment outlines exactly which quality management system or conformity certificates are acceptable. These include:
- Full Quality Assurance Certificates (Annex II)
- Production or Product Quality Assurance Certificates (Annex V/VI)
- Design Examination Certificates (Annex III/IV)
- Type-Examination Certificates (Annex III/V)
The acceptable documents vary based on:
- Whether the device is sterile or non-sterile
- Whether the device has a measuring function
- Whether it falls under AIMD, MDD, or IVDD
Careful mapping is required to align your documentation with the correct annex from the applied UK Directive.
GLOBAL IMPACT: WHAT THIS MEANS FOR MANUFACTURERS
Unlocks Market Entry for UK-Certified Products
Manufacturers holding UK-based certificates can now leverage those approvals in Australia without duplicating compliance efforts.
Regulatory Streamlining for MDSAP Participants
Multinational firms using the MDSAP route benefit from increased recognition of audit partners, resulting in fewer audits and reduced compliance complexity.
Simplified Pathway for US Devices
If your device is 510(k) exempt, a short statement now suffices for ARTG application no need for extensive technical files.
TGA AMENDMENT TIMELINE
The exact timeline for the Therapeutic Goods Administration (TGA) amendment titled “Therapeutic Goods (Medical Devices Information that Must Accompany Application for Inclusion) Amendment Determination 2025”:
- The instrument was registered on 30 October 2025.
- It comes into full effect (commencement of the whole instrument) 1 December 2025.
FINAL THOUGHTS
This amendment marks a significant advancement in regulatory cooperation. It underscores Australia’s continued commitment to global alignment while promoting efficiency for device manufacturers. For medical device companies seeking ARTG inclusion, this update opens doors to faster, more flexible submissions especially for those already operating in the UK, US, or MDSAP markets.