Regulations
Last Updated: 29 July 2026
For any manufacturers of medical devices and in vitro diagnostic (IVD) devices intending to enter into the Australian market, it is essential that you must have a comprehensive product lifecycle approach where post-market vigilance is well-controlled. Morulaa Health Tech serves as your dedicated Australian Therapeutic Goods Administration (TGA) consultant for regulatory purposes. We coordinate with your local sponsors and develop your Australia-specific documents and help you with completing your Australia Medical device Registration.
Technical Strategy for Australia medical device registration and ARTG Inclusion
Defining the "Kind of Medical Device" Under Australia Therapeutic Goods Medical Devices Regulations
Your ability to use an effective regulatory pathway depends on the correct determination of your device "kind." According to the Australia Therapeutic Goods medical devices regulations, devices are assigned to one ARTG entry only when they have the same sponsor, manufacturer, GMDN code and Class.
The 15 Essential Principles (Schedule 1) for Australia medical device registration
To meet the Australia medical device registration criteria, medical devices need to prove their compliance with the Essential Principles listed in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. This regulation comprises General Principles which include being appropriate to their intended purposes, having benefits exceeding any negative impacts, and not posing risks to people's health and safety; and Design and Construction Principles. Technical mapping of these principles includes documentation of clinical evidence (Clause 14), material biocompatibility (Clause 7), and sterility of devices (Clause 8).
Also, as your TGA regulatory consultant, we encourage dossiers that include the latest technologies. Ex. TGA requires special evidence related to Software as a Medical Device (SaMD) and AI systems – this includes the security of such systems (Clause 12.1) and transparent presentation of version and build number (Clause 13B). Besides, information provided with the device must satisfy labeling criteria of Clause 13 and the presence of Australian Sponsor's name and contact information on the device/packaging of the device. Technical files of manufacturers should also include data about environmental characteristics of products and their possible radiation exposure to obtain an entry on the Australian Register of Therapeutic Goods (ARTG).
Leveraging Comparable Overseas Regulators (COR) for Australia medical device registration
In order to be able to go through the process of abbreviated TGA assessment procedure, the manufacturer needs to provide proof of market authorization from specific Approved Overseas Regulators. These proof documents will prove the conformity with the requirements of quality management systems and other key requirements. TGA has stated that the market approval of EU such as MDR or IVDR certificates is acceptable. Market authorization of US FDA such as Premarket Approvals and 510(k) clearance is acceptable as well. Market authorization of Health Canada giving Medical Device License is acceptable. Market authorization from Japan's MHLW/PMDA giving Premarket approvals is also acceptable. Also, the market authorization from Singapore’s HSA having Register entries is acceptable. All these proofs of market authorizations should come from one of these sources for the TGA assessment procedure to use. The TGA assessment pathway is vital for the manufacturers to meet the requirements of TGA. In order for these TGA assessments to be eligible for abridgement, it is required to have the same design, intended use, user population, and indication as the version approved by the COR. Furthermore, particular certificates and audit reports issued by the Medical Device Single Audit Program (MDSAP) are also acceptable provided that the manufacturer meets the requirements of TGA Regulations 2002
The technical implementation of this pathway is divided into Part A (Conformity Assessment Abridgement) and Part B (ARTG Inclusion), where both parts require mapping of manufacturer evidence and product assessment data. Under Part A, initial or re audit reports from the overseas regulators, for example EU MDD/MDR Full Quality Assurance (FQA) report, can allow the TGA to reduce the regulatory burden of performing an on-site audit by conducting a desk assessment of the QMS. Under Part B for ARTG inclusion, the manufacturer has to present an evidence of sponsor and particular evidence of product assessment (De Novo Decision Summary or 510(k) Summary) that should correspond to the classification line items defined by the TGA. High risk devices, including Class 3 IVDs and companion diagnostics, require Performance Assessment Evaluation Reports (PEAR) and Technical Documentation Assessment Reports (TDAR) from Notified Bodies in order to speed up the mandatory preliminary assessment phase.
Independent Australian Sponsorship by Your TGA regulatory consultant
Under the Therapeutic Goods Act, a resident Sponsor is a mandatory legal requirement for all foreign manufacturers. Morulaa, being your TGA regulatory consultant, can connect you to an Independent Australian Sponsor who will take the legal responsibility for your market authorization and Australia medical device registration.
Post Market Vigilance: 2026 Reporting Standards for Australia Therapeutic Goods Medical Devices Regulations
For all approved medical devices, after the granting of Australia medical device registration , it is important to undertake adverse event reporting carefully, where such events range from simple screening of individual incidents to Level 3 investigations involving a thorough examination of cluster incidents or device malfunctioning.
This kind of surveillance is aided by environmental scanning and confidential advice from other countries' regulators as well as an analysis of medical literature. The technical requirement of regulation 5.7 requires complete commitment to reporting time frames according to the severity of the data signal. Sponsorship requirements for medical devices in terms of adverse event reporting include the following time frames:
48 hours: Any event that poses a serious public health risk.
10 days: Events leading to death or serious injury.
30 days: Any event that could potentially lead to death or serious injury.
60 days: Change in regulatory status of a particular device including suspension or revocation of Conformity Assessment (CA) certificate.
Our regulatory consultants as your TGA will also offer advice for those devices which are High Risk including Class III devices, AIMDs and Implantable Class IIb devices where sponsors have to submit consecutive annual reports on 1 October for all supply information, adverse incidents and complaints made during the financial year.
Government Fees & Assessment Timelines: How medical devices in Australia are regulated by the TGA
Estimated statutory fees and timelines for ARTG inclusion:
FAQS
Considering how medical devices in Australia are regulated by specific audits, what if we have CE Marking?
The TGA has used the COR pathway to shorten assessments but still holds the legal rights to conduct a desktop or on-site audit of any application. In case there is a biological component in the device, the audit is mandatory regardless of any European certificate, based on Australian Therapeutic Goods medical devices regulations.
How are System or Procedure Packs handled?
Based on the Section 41BF, connected or co-packed devices are considered one unit. The kit will have the highest classified component category (for instance, if an implant is Class III, then the kit becomes Class III as well). As we see, medical devices in Australia are subject to rigid assembly regulations; therefore, contacting your TGA regulatory consultant is necessary.
What are the retention requirements for manufacturing and distribution records?
In case of Class III, AIMD and implantable Class IIb devices, the records are to be maintained for 10 years. In all other cases, 5 years are sufficient.
Can I rely on my ISO 13485 for the TGA?
No, for IVDs. By the middle of 2023, the TGA's grace period for ISO 13485 as the main proof will end and each new application for IVD will need conformity assessment information according to the recent Australian medical device regulations. This is our specialization - to help the manufacturers adapt to these changes and prepare the technical files in accordance with the TGA requirements.
How is "Device Vigilance" managed by a TGA regulatory consultant?
This includes malfunction detection, problems with labeling or "off label" use which cause deteriorated health conditions of a patient. As your Sponsor, we contact the TGA within 24 to 48 hours upon receiving such report for further discussion about possible actions or recall management.