TGA Registration for CE-Marked and FDA-Cleared Medical Devices

A CE mark or an FDA clearance does not open an automatic door into the Australian market. Both can support a Medical Device Registration application. In defined circumstances, they can also reduce duplicated technical review. But approval still depends on rules set by the Therapeutic Goods Administration (TGA). The device also must be listed on the Australian Register of Therapeutic Goods (ARTG), the register the TGA maintains. A device cannot be legally supplied in Australia until it appears there.

This article tells exactly where that overseas evidence helps and how to structure an ARTG application so existing regulatory work is put to good use rather than duplicated.

Can CE Marking or FDA Clearance Speed Up TGA Registration?

Sometimes, yes, but only for specific parts of the TGA Approval Process. The TGA recognises a defined list of comparable overseas regulators, including European Union notified bodies operating under the EU Medical Device Regulation and the US Food and Drug Administration. Sponsors can submit their assessments and approvals as supporting evidence for a TGA ARTG Inclusion application, or to support an abridged TGA conformity assessment.

That is a narrower thing than automatic approval. A CE certificate or an FDA clearance can stand in for parts of the manufacturer’s evidence and conformity assessment history the TGA would otherwise need to generate itself. It does not remove the need for an Australian sponsor, an Australian classification decision, compliance with the Essential Principles set out in Australian legislation or ongoing post-market reporting to the TGA. Every application for Medical Device ARTG Inclusion is still assessed against Australian requirements, even when it leans heavily on overseas evidence.

CE Marking vs FDA Clearance: Which Can Be Used for TGA Registration?

Both are accepted forms of evidence, but they are not interchangeable, and they are not the same kind of decision. CE marking is a manufacturer declaration, backed in most risk classes by an independent notified body assessment under EU Regulation 2017/745. FDA clearance and FDA approval are regulatory decisions issued directly by the FDA itself, through different routes depending on device risk. The TGA treats each on its own terms.

Using CE Marking for TGA Registration

CE Marking TGA Registration relies mainly on certificates issued by EU notified bodies designated under the EU Medical Device Regulation. Where a device holds a valid MDR certificate from a recognised notified body, that certificate can be submitted as manufacturer evidence supporting an ARTG application. In some cases, it can also support a reduced-scope TGA conformity assessment. The certificate needs to be current and cover the correct scope. A lapsed certificate or one that covers a different model configuration will not carry the application forward.

Some devices are still supplied under an older MDD certificate rather than a full MDR certificate. That doesn’t automatically disqualify them. The TGA will accept an MDD certificate as Manufacturer Evidence, but only if the sponsor also provides evidence that the manufacturer has a contract in place with an MDR notified body for that device. This extended acceptance runs until 31 December 2027 for Class III and implantable Class IIb devices, and until 31 December 2028 for other Class IIb and lower-risk devices. Without that contract evidence, an expired MDD certificate won’t support the application.

Using FDA Clearance for TGA Registration

FDA Clearance TGA Registration works a little differently because the FDA issues several distinct types of decisions. The TGA recognises 510(k) clearance, De Novo classification and Premarket Approval (PMA) as forms of comparable overseas evidence, with the specific use depending on device class.

For Class IIb implantable devices in particular, the TGA has stated it will continue assessing whether a 510(k) or De Novo decision is genuinely aligned with Australian requirements before relying on it. These applications are likely to be selected for audit, with supporting documentation and clinical evidence expected on request. FDA approval through the PMA route is a different, more rigorous decision than 510(k) clearance. The two should never be described as equivalent when preparing a TGA submission.

What If You Have Both CE Marking and FDA Clearance?

Holding both does not double the benefit. But it does give a sponsor more evidence to choose from when structuring the application.

In practice, a device with current CE marking and current FDA clearance can present whichever body of evidence best matches:

• The Australian classification, and
• The specific conformity assessment route being pursued.

But it does not exempt the device from making an Australian classification decision, from Essential Principles compliance, from appointing an Australian sponsor or from ongoing post-market reporting to the TGA.

What TGA Requirements Still Apply After CE or FDA Clearance?

Every device supplied in Australia needs:

• Its own Australian Medical Device Classification
• Its own Australian sponsor
• Its own ARTG entry
• Compliance with Australian labelling and instructions for use requirements
• Adverse event reporting to the TGA, not to the FDA or a notified body
• A response to any TGA request for clinical evidence or technical documentation if the application is selected for audit

These sit at the core of Australian Medical Device Regulations, regardless of overseas history.

How to Fast-Track Your TGA/ARTG Application

The sequence below reflects how the TGA actually structures an ARTG Registration application.

Step 1: Determine Your Australian Device Classification

This is the starting point for TGA Medical Device Classification. It decides almost everything downstream, including which conformity assessment route applies and what evidence the TGA will expect. Australian classification rules appear in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. They must be applied independently of EU or US classification, even for a device that already carries a CE mark or FDA clearance.

Step 2: Assess Your Existing CE/FDA Regulatory Evidence

This is the point to check certificate validity and scope against what will actually be supplied in Australia. A current CE certificate, a 510(k) summary, a De Novo decision or a PMA approval each carries different evidentiary weight depending on device class and the specific TGA route being pursued.

Step 3: Identify the Appropriate TGA Route

Devices can generally proceed either through a full TGA conformity assessment, or through a route that relies on accepted overseas evidence to support the application. This is subject to the requirements set out in TGA guidance. The correct choice depends on classification, the strength of the available overseas evidence, whether the device type is one the TGA flags for closer review and how quickly the sponsor needs the outcome.

Step 4: Appoint an Australian Sponsor

A TGA Australian Sponsor is a mandatory requirement for any manufacturer that is not based in Australia. The sponsor must be an Australian resident or a body incorporated in Australia with a representative in the country.

Under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, the sponsor is the entity that submits the ARTG application. It also holds an ongoing relationship with the TGA. Beyond that, the sponsor carries post-market responsibilities, including adverse event reporting and keeping ARTG entries accurate and current.

Step 5: Prepare Manufacturer’s Evidence

Manufacturer’s Evidence is the documentation that demonstrates the manufacturer’s quality management system and conformity assessment history. Depending on the device and the route chosen, this can include a CE certificate, FDA documentation, an MDSAP audit report or a TGA-issued conformity assessment certificate.

This evidence is submitted through the TGA Business Services portal and generally needs to be accepted before the ARTG inclusion application itself can proceed.

Step 6: Compile and Submit the ARTG Application

The application brings together classification, manufacturer evidence, sponsor details, device description, intended purpose and the relevant declaration of conformity. Application fees are payable at submission. TGA does not begin its review until the applicable fee is paid.

Step 7: Respond to TGA Questions or Audit Requests

Not every application is audited, but many are, particularly for higher-risk devices or where the TGA’s audit selection criteria are triggered. Audited applications fall into Level 1 or Level 2 review, with Level 2 involving a more in-depth review against the Essential Principles.

Responding promptly and completely to information requests is one of the few things genuinely within a sponsor’s control once an audit begins.

Step 8: Obtain ARTG Inclusion

Once preliminary assessment and, if applicable, audit review are complete, the device is either included in the ARTG or refused. Successful applicants can print an ARTG certificate through the TGA Business Services portal once inclusion is confirmed.

Documents Required for TGA Registration

Documentation depends on device classification, the conformity assessment route, whether overseas evidence is being relied on and how the device is ultimately supplied in Australia. Not every document below is mandatory for every device.

ISO 13485 is the quality management standard behind all of these routes. But the TGA does not accept a standalone ISO 13485 certificate as Manufacturer Evidence for non-IVD devices. What counts as evidence depends on how that standard was actually assessed.

A CE certificate issued by an EU Notified Body demonstrates an ISO 13485-based quality management system under the EU regulatory route. An MDSAP audit report may be used as Manufacturer Evidence when the report confirms that the manufacturer was assessed against the relevant requirements of the Therapeutic Goods (Medical Devices) Regulations 2002.

In the United States, the FDA’s Quality Management System Regulation (QMSR), effective from February 2026, incorporates ISO 13485:2016 into 21 CFR Part 820. Here, FDA QMSR requirements are separate from whether the manufacturer also has MDSAP certification..

Common Reasons for TGA Registration Delays

Most delays trace back to mismatches rather than missing paperwork entirely.

• Incorrect Australian classification, often from assuming EU or FDA classification carries across directly
• Expired CE certificates or FDA clearances that were valid at the time of preparation but lapsed before submission
• Model number or configuration differences between the overseas certificate and the device actually being supplied in Australia
• Incomplete sponsor information or gaps in manufacturer evidence
• Clinical evidence that supported the overseas approval but does not fully address the Australian intended purpose

How Long Does TGA Registration Take?

The TGA must complete preliminary assessment within 20 working days of a valid, paid application. That period covers only the initial check of whether the application is complete and correctly documented. If the application is selected for audit, the overall TGA registration timeline extends beyond this.

The total time then depends on device classification, audit level, how quickly the sponsor responds to any request for information, and whether additional clinical evidence is requested. A specific number of weeks or months covering a specific device and route should be confirmed against the current guidance for the relevant classification.

TGA Registration vs ARTG Inclusion: What Manufacturers Need to Know

TGA Registration Process and ARTG inclusion (sometimes called ARTG Medical Device Registration) are often used interchangeably, but they describe different stages of the same activity. The TGA Registration Process is the full set of steps that leads to a decision:

• Classification
• Sponsor appointment
• Evidence preparation
• Application submission
• Possible audit

ARTG inclusion is the outcome of that process. It means the device is listed on the Australian Register of Therapeutic Goods and can lawfully be supplied in Australia. Submitting an application or having overseas evidence accepted, is not enough on its own. Supply is only lawful once inclusion is confirmed.

What Happens After ARTG Inclusion?

Inclusion in the ARTG is not the end of TGA Registration Requirements. Sponsors take on ongoing obligations that continue for as long as the device stays on the market.

Post-market responsibilities includes:

• Paying annual charges to keep the ARTG entry active
• Reporting adverse events and overseas regulatory actions to the TGA
• Maintaining accurate and current ARTG entries
• Updating manufacturer evidence when certificates are renewed, lapse, or change scope
• Meeting additional reporting conditions where these apply, including for active implantable devices and certain Class IIb implantables

None of this changes because the original application relied on CE marking or FDA clearance. Post-market obligations in Australia run on Australian timelines and Australian reporting channels.

Conclusion

CE marking and FDA clearance are not shortcuts around the TGA. They are supporting evidence. And how far that evidence goes depends on classification and how closely it matches what’s actually being supplied in Australia. Manufacturers who confirm classification early and check certificate scope before submission avoid most of the delays.

Artixio helps manufacturers and sponsors assess what CE marking and FDA evidence can realistically support, and builds ARTG applications structured to avoid common mismatches. If you need support with TGA registration or ARTG inclusion, reach out to the team at info@artixio.com.

FAQs

Q1. Does CE marking guarantee TGA approval?

No. CE marking can support parts of a TGA Registration application as accepted manufacturer evidence, but Australian classification, sponsor appointment, Essential Principles compliance and ongoing post-market reporting still apply independently.

Q2. Does FDA clearance guarantee ARTG inclusion?

No. FDA 510(k), De Novo and PMA decisions can be submitted as comparable overseas evidence, but the TGA still applies its own classification and assessment requirements and higher-risk devices may still be selected for audit.

Q3. Is an Australian Sponsor the same as an EU Authorised Representative?

No. The Australian Sponsor has its own defined role under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, including submitting the ARTG application and managing ongoing post-market obligations directly with the TGA.

Q4. How much does TGA registration cost?

Costs vary by device classification and whether an application audit or conformity assessment fee applies. The TGA publishes current application and assessment fees in its official fees and charges summary and no fixed figure applies across every device type.

Q5. Can a device with both CE marking and FDA clearance skip TGA review entirely?

No. Holding both forms of overseas evidence can strengthen an application, but every device still requires its own Australian classification decision and its own ARTG inclusion outcome.