Regulations
For medical device and IVD manufacturers entering the Australian market - the TGA compliance requires a complete lifecycle strategy where post market vigilance is tightly controlled. Morulaa Health Tech acts as your specialized Australian Therapeutic Goods Administration TGA regulatory consultant. We work closely with local sponsors and prepare the Australia specific documentation, ARTG inclusion strategy under the Australia Therapeutic Goods medical devices regulations.
Technical Strategy for TGA approval and ARTG Inclusion
1. Defining the "Kind of Medical Device" Under Australia Therapeutic Goods Medical Devices Regulations
The efficiency of your regulatory roadmap depends on accurately identifying your device "kind." Under the Australia Therapeutic Goods medical devices regulations, devices are grouped into a single ARTG entry only if they share the same sponsor, manufacturer, GMDN code and Class
2. The 15 Essential Principles (Schedule 1) for TGA approval
To comply with the TGA approval requirements, medical devices must demonstrate adherence to the Essential Principles set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002. These principles are divided into General Principles requiring that devices are suitable for their intended purpose, have benefits that outweigh undesirable effects, and do not compromise health or safety and specific Design and Construction requirements. Technical mapping for these principles involves documentation of clinical evidence (Clause 14), material biocompatibility (Clause 7), and sterilization integrity (Clause 8)
Additionally as your TGA regulatory consultant we support dossiers which have the latest technologies. Ex. TGA mandates specialized evidence for Software as a Medical Device (SaMD) and AI systems, focusing on cybersecurity (Clause 12.1) and the transparent display of version and build numbers (Clause 13B). Furthermore, information provided with the device must meet labeling standards under Clause 13 and that the Australian Sponsor’s identity and contact details are correctly located on the device or its packaging. Manufacturers must also maintain technical files that account for environmental properties and potential radiation exposure to secure and maintain an entry on the Australian Register of Therapeutic Goods (ARTG).
3. Leveraging Comparable Overseas Regulators (COR) for TGA approval
To use the abridged TGA assessment pathway, manufacturers have to give proof of market approval from certain Comparable Overseas Regulators or assessment bodies. This proof must show that they follow the rules of quality management systems and other important principles. The TGA says it is okay to use approval from the European Union like MDR or IVDR certificates. It is also okay to use approval from the U.S. FDA, like Premarket Approvals and 510(k) clearances. The TGA accepts approval from Health Canada, which gives Medical Device Licences. It also accepts approval from Japan's MHLW/PMDA, which gives Premarket approvals. The TGA accepts approval from Singapore’s HSA, which has Register entries. Manufacturers have to get this approval from one of these places to use the TGA assessment pathway, for the TGA assessment. The TGA assessment pathway is important for manufacturers to follow the rules of the TGA. For these assessments to be eligible for abridgement, the device must maintain the exact same design, intended purpose, user base, and indications as the version approved by the COR. Furthermore, specific certificates and audit reports issued under the Medical Device Single Audit Program (MDSAP) are accepted provided they demonstrate that the manufacturer was found to comply with relevant aspects of the Therapeutic Goods (Medical Devices) Regulations 2002.
The technical execution of this pathway is into Part A (Conformity Assessment Abridgement) and Part B (ARTG Inclusion), each requiring a mapping of manufacturer evidence and product assessment data. Under Part A, overseas initial or re-audit reports such as an EU MDD/MDR Full Quality Assurance (FQA) report may allow the TGA to reduce its regulatory burden by performing a desk assessment of the QMS in lieu of a mandatory on-site audit. For ARTG inclusion under Part B, sponsors must submit accepted Manufacturer Evidence (typically a QMS certificate) and specific Evidence of Product Assessment (such as a De Novo Decision Summary or 510(k) Summary for Class IIb devices) that match 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 to expedite 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, as your TGA regulatory consultant, connects you to a reliable Australian Sponsor who takes the legal responsibility for your market authorization and TGA Approval
Post-Market Vigilance: 2026 Reporting Standards for Australia Therapeutic Goods Medical Devices Regulations
Following TGA approval, medical device manufacturers must ensure adverse event reporting with care, where cases are classified from simple screening for isolated incidents to Level 3 Investigations involving a full examination of potential clusters or device-specific malfunctions.
This surveillance is supported by environmental scanning, including confidential advice from international regulators and the critical review of medical literature. Technical compliance with Regulation 5.7 requires absolute adherence to reporting windows based on the severity of the data signal. A sponsor's reporting obligations for medical devices include several timelines:
48 hours: For any event linked to a serious public health threat.
10 days: For incidents resulting in death or serious injury.
30 days: For events that could have potentially led to death or serious injury.
60 days: For changes in regulatory status, specifically the restriction, suspension, or revocation of a Conformity Assessment (CA) certificate.
As your TGA regulatory consultant, we also advise high-risk devices specifically Class III, AIMD, and implantable Class IIb units where sponsors must submit consecutive annual reports by 1 October that detail all supply data, adverse events, and complaint logs from the previous 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?
While the TGA utilizes the COR pathway to abridge assessments, they maintain the statutory right to conduct a desktop or on-site audit of any application. For devices with biological components, a mandatory audit is often required despite existing European certification, per the Australia Therapeutic Goods medical devices regulations.
How are System or Procedure Packs handled?
Under Section 41BF, interconnected or co-packaged goods (e.g., dental implant kits) are regulated as a single entity. The kit takes the classification of the highest classified component (e.g., a Class III implant makes the entire kit Class III). Since medical devices in Australia are regulated by strict assembly rules, consulting your TGA regulatory consultant is vital.
What are the retention requirements for manufacturing and distribution records?
For Class III, AIMD, and implantable Class IIb devices, records must be maintained for 10 years. All other classifications require 5 years of record retention.
Can I rely on my ISO 13485 for the TGA?
Not for IVDs. The TGA’s grace period for using ISO 13485 as primary evidence ended in mid-2023. Now, every new IVD application must be backed by specific conformity assessment data as required by the latest Australian medical device regulations. We specialize in helping manufacturers transition to these new requirements, ensuring your technical files are exactly what the TGA is looking for.
How is "Device Vigilance" managed by a TGA regulatory consultant?
Vigilance includes identifying malfunctions, labeling inadequacies, or "off-label" use that leads to health deterioration. As your Sponsor, we liaise with the TGA within 24 to 48 hours of becoming aware of a reportable event to propose action plans and manage potential recalls.
TGA Regulatory Consultant
TGA Approval