Comparable Overseas Regulators
Overview
Australia's medical device regulatory framework has progressively expanded its acceptance of conformity assessment evidence from comparable overseas regulators. This is the most common pathway for manufacturers who already hold CE marking, FDA clearance or approval, or other recognised overseas approvals — avoiding the need for a separate TGA conformity assessment certification in most cases. The accepted overseas regulators and the specific evidence types accepted are updated periodically by the TGA.
Accepted Comparable Overseas Regulators
The TGA currently accepts evidence from the following comparable overseas regulators and assessment bodies:
| Regulator | Jurisdiction | Evidence Type |
|---|---|---|
| EU Notified Bodies (under EU MDR 2017/745) | European Union | CE Certificate (MDR) |
| EU Notified Bodies (under EU MDD / AIMDD) | European Union | CE Certificate (MDD/AIMDD) — transitional |
| EU Notified Bodies (under EU IVDR 2017/746) | European Union | CE Certificate (IVDR) |
| US Food and Drug Administration (FDA) | United States | 510(k), PMA, De Novo |
| Health Canada | Canada | Medical Device Licence |
| UK MHRA | United Kingdom | UKCA certificate |
| Singapore Health Sciences Authority (HSA) | Singapore | HSA approval |
| MDSAP | Multi-country | MDSAP certificate (QMS only) |
| Japan PMDA | Japan | PMDA QMS certificate |
The definitive list of accepted documents and their combinations for each device class is set out in the TGA guidance document on use of overseas regulator evidence (updated 1 July 2024):
👉 Use of market authorisation evidence from comparable overseas regulators — TGA guidance (PDF)
How Overseas Evidence is Used
Overseas regulator evidence can be used in two ways in the Australian system:
1. As Manufacturer Evidence for ARTG inclusion applications The majority of ARTG applications for devices above Class I use overseas regulator evidence as the required manufacturer evidence. The specific combination of documents required varies by device class and is set out in Table 2 of the comparable overseas regulator guidance.
2. To support abridgement of TGA conformity assessment applications Manufacturers applying for a TGA Conformity Assessment Certificate may submit overseas audit reports to reduce the amount of assessment the TGA needs to conduct (desk assessment rather than on-site audit, for example).
Important Nuances
EU MDD vs EU MDR The EU transitioned from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR 2017/745) with a deadline that has been progressively extended. The TGA accepts both MDD and MDR certificates, but Class III applications supported by MDD certificates are subject to mandatory audit (as of the 2024 amendments). Check the current TGA guidance for the specific requirements.
IVDR transition Similarly, the EU IVD Directive (IVDD) is being phased out in favour of the IVDR (2017/746). The TGA's acceptance of IVDD vs IVDR certificates for IVD applications is being updated progressively as the EU transition proceeds.
Mandatory audits still apply Using overseas regulator evidence does not automatically avoid an audit. Class III applications supported by EU MDD certificates or US 510(k) approvals are subject to mandatory audit under the 2024 amendments to Regulation 5.3. See the application audit guidance for the full mandatory audit criteria.
👉 Application audit criteria — TGA
Official Sources
- Using assessments from comparable overseas regulators — TGA
- Use of overseas regulator evidence (PDF, updated 2024) — TGA
- Regulation 5.3 — MD Regulations 2002