Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Register inclusion of medical devices and IVDs using manufacturer evidence

Australia · Therapeutic Goods Administration · Medical devices

Reliance route, recognition or verificationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

7 requirements

What is the Register inclusion of medical devices and IVDs using manufacturer evidence in Australia?

Most devices above the lowest risk are included in the register on the basis of manufacturer evidence. This evidence can be a certificate from the agency or from a comparable overseas regulator or assessment body. Some applications must be audited, but certain overseas approvals remove the mandatory audit. Class I sterile or measuring, Class IIa, IIb and III devices, and Class 2 to 4 IVDs, including software that is a medical device.

How much does the Register inclusion of medical devices and IVDs using manufacturer evidence cost?

The class iii device, application fee is A$1,603 for FY2026-27.

What are the steps of the Register inclusion of medical devices and IVDs using manufacturer evidence?

1. Manufacturer classifies the device; 2. Lodge manufacturer evidence; 3. Application for inclusion; 4. Preliminary assessment (20 days); 5. Application audit; 6. Decision on inclusion.

Does the Register inclusion of medical devices and IVDs using manufacturer evidence rely on other regulators?

Yes. It relies on approvals from Canada, European Union, United Kingdom, Japan, Singapore, United States (recognition, recognition, recognition, recognition, recognition, recognition).

Outcome: Inclusion of the kind of device in the Australian Register of Therapeutic Goods.

Legal basis: Therapeutic Goods Act 1989, Chapter 4; Therapeutic Goods (Medical Devices) Regulations 2002, regulation 5.3; Therapeutic Goods (Overseas Regulators) Determination 2018

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 20 days end to end with the official step targets. Targets, not actual times.

Steps

In order, with the official target for each step

1. Manufacturer classifies the deviceThe manufacturer classifies the device under the rules. If several rules apply, the highest class applies.
2. Lodge manufacturer evidenceThe sponsor sends the conformity certificate or overseas evidence, which the agency must accept before the inclusion application.
3. Application for inclusionThe sponsor applies and pays the application fee.
4. Preliminary assessment20 working daysThe agency completes preliminary assessment within 20 working days.
5. Application auditonly in some casesMandatory for some applications, otherwise possible. Level 1 checks the application and evidence; Level 2 adds an in-depth technical review.
6. Decision on inclusionThe device is included in the register or the application is refused.

Requirements

What the applicant must provide or meet

Quality system

Accepted manufacturer evidenceA conformity assessment certificate or equivalent overseas evidence is accepted before the inclusion application can be made.

Reference approval

Same device as approved overseas(in some cases)Overseas evidence must cover the same device, with the same design, intended purpose and indications.

Clinical evaluation

Essential PrinciplesThe device must meet the Essential Principles; an audit can review clinical evidence, risk management and technical files.

Other

Mandatory audit(in some cases)Applications for Class III devices and for Class 3, Class 4, self-testing and point-of-care IVDs are audited, unless a certificate from the agency, an EU MDR or IVDR notified body certificate, or certain US, Canadian, Japanese or Singapore approvals cover the device.

Local presence

Australian sponsorThe sponsor must be a recognised Australian-based legal entity, usually the importer, with a working relationship with the manufacturer.

After approval

Official time targets

Targets, not actual review times

Validationofficial guidance. Preliminary assessment period as described by the agency.

20 working days

Fees

Official amounts in the local currency

Fee	Amount
Application audit assessment, Class 4 IVD (most)Other · FY2026-27	A$25,350
Application audit assessment, Class 3 IVDOther · FY2026-27	A$25,350
Application audit assessment, Level 2, Class III devicesOther · FY2026-27 · No audit fee for a non-mandatory audit.	A$18,118
Application audit assessment, Level 1 (non-IVD devices)Other · FY2026-27 · No audit fee for a non-mandatory audit.	A$4,926
Class III device, application feeApplication · FY2026-27	A$1,603
IVD inclusion application fee (all classes)Application · FY2026-27	A$1,244
Class IIa device, application feeApplication · FY2026-27	A$1,244
Class IIb device, application feeApplication · FY2026-27	A$1,244
Class I measuring device, application feeApplication · FY2026-27	A$651
Class I sterile device, application feeApplication · FY2026-27	A$651

Reliance on other regulators

CanadaRecognitionA Health Canada medical device licence removes the mandatory audit.
European UnionRecognitionCertificates from notified bodies designated by EU member states. EU MDR or IVDR certificates remove the mandatory audit.
United KingdomRecognitionCertificates from UK approved bodies, accepted since 1 December 2025.
JapanRecognitionPre-market certification or approval by the Japanese ministry or the Pharmaceuticals and Medical Devices Agency.
SingaporeRecognitionAn entry in the Singapore Register of Health Products.
United StatesRecognitionEvidence from the Food and Drug Administration. A premarket approval order removes the mandatory audit.

Rule changes

Review of the exclusion for some digital mental health toolsProposed, September 30, 2026
Older EU directive certificates accepted during the EU transitionIn force, August 25, 2026
UK approved bodies added as comparable overseas regulators for devicesIn force, October 30, 2025, effective December 1, 2025

Register inclusion of medical devices and IVDs using manufacturer evidence

What is the Register inclusion of medical devices and IVDs using manufacturer evidence in Australia?

How much does the Register inclusion of medical devices and IVDs using manufacturer evidence cost?

What are the steps of the Register inclusion of medical devices and IVDs using manufacturer evidence?

Does the Register inclusion of medical devices and IVDs using manufacturer evidence rely on other regulators?

How the pathway works

Timeline with clock stops

Steps

Requirements

Quality system

Reference approval

Clinical evaluation

Other

Local presence

After approval

Official time targets

Fees

Reliance on other regulators

Rule changes

Eligibility