Australia medical device registration timeline

Source-linked clocks

Therapeutic Goods Administration (TGA) review clocks and end-to-end planning ranges, using the 5-class (I, IIa, IIb, III, AIMD) classification system.

7 pathways7 of 7 clocks verifiedvalidity 5 yearsMDSAP acceptedreviewed 2026-08-30tga.gov.au

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I — ARTG inclusion(Inclusion in the Australian Register of Therapeutic Goods) TGA notifies the inclusion decision within 20 working days after the day the application fee was paid, the same statutory clock that applies to every class	20 working days	0.5-1 months	—	Verified
Class IIa — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence) The 20-working-day statutory clock runs to the inclusion decision, not to the end of an audit: if the application is selected for audit there is no legislated limit on what follows	20 working days	1-1.5 months	0.8-1 months	Verified
Class IIb — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence) Same 20-working-day statutory inclusion clock; audit selection is more likely at this class and suspends any published limit	20 working days	1.5-2 months	1-1.5 months	Verified
Class III — ARTG inclusion(Inclusion in the ARTG on overseas or TGA conformity assessment evidence) The inclusion decision itself still carries the 20-working-day statutory clock. What makes Class III slow is what sits either side of it: an application audit, which has no legislated timeframe, and where TGA conformity assessment is required, a separate certificate that must be obtained first	20 working days	6-9 months	3-5 months	Verified
TGA Conformity Assessment certificate — new or substantial change(TGA-issued conformity assessment certification) Regulation 4.3 caps every Conformity Assessment application, including IVDs, at 255 working days. Within that cap TGA publishes a non-legislated target of 160 business days and a maximum of 200, aiming to meet the target in 90% of applications	160-200 working days	10-15 months	—	Verified
TGA Conformity Assessment certificate — ACMD advice or on-site facility audit(TGA-issued conformity assessment certification with committee referral or on-site audit) Applies where the Advisory Committee on Medical Devices is consulted or an on-site TGA audit of manufacturing facilities is required, both of which are most common for high-risk or novel devices	190-225 working days	1-1.3 years	—	Verified
TGA Conformity Assessment certificate — recertification(Recertification of an expiring TGA conformity assessment certificate) Target 80 business days with TGA and a maximum of 150, plus 40-60 business days of applicant time, for roughly 6-10 months in total	80-150 working days	6-10 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Australia Medical Device Registration Process

Step-by-step TGA registration process. Total estimated timeline: 0.5-1 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by TGA. Appoint a Australian Sponsor.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to TGA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

TGA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

20 working days

In-depth technical assessment of device safety and performance. TGA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, TGA issues Australia market authorization certificate.

Summary: The Australia medical device registration process through Therapeutic Goods Administration (TGA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Expedited pathways

Priority Review Pathway30-50% faster

Front-of-queue placement for novel devices addressing unmet needs

Eligibility: Novel device, Addresses unmet clinical need, No marketed alternatives

Prior approval recognition

EU CE MarkAbridged assessment route - major timeline reduction30-50%

FDA 510(k)Accepted for Class IIa/IIb20-30%

MDSAPEliminates separate QMS audits2-3 months

Key requirements

Australian Sponsor (for foreign manufacturers)
ARTG (Australian Register of Therapeutic Goods) listing
Conformity assessment documentation
MDSAP or TGA audit
Two statutory clocks and nothing else: 20 working days to notify the inclusion decision, and 255 working days to process a Conformity Assessment application under Regulation 4.3. Application audits have no legislated timeframe, and neither does evaluating an application to vary an ARTG entry
Failing preliminary assessment is a refusal, not a request for more information, and the application fee is neither refunded nor transferable to a resubmission
Audit fees are payable only for mandatory audits, and TGA cannot start the audit until they are paid; non-mandatory audit selection currently carries no fee
Software variations that transition a software device to new intended hardware carry their own 3-5 business day target

MDSAP: Eliminates separate TGA QMS audits, 5-year certificate validity

Primary regulator sources

tga.gov.au · TGA — processing your application for inclusion of a medical device: the decision is notified within 20 working days after the day the application fee was paid tga.gov.au · TGA — applying for a Conformity Assessment certificate for medical devices: Regulation 4.3 requires processing within 255 working days, with non-legislated targets of 160/200 business days for new or substantial applications, 190/225 where ACMD advice or an on-site audit is needed, and 80/150 for recertification tga.gov.au · TGA — understanding the medical device application audit process: statutory 20-working-day preliminary assessment, non-IVD Level 2 first-round specialist assessment expected in 100 working days, sponsor responses due in 20-40 business days tga.gov.au · TGA — understanding processing timeframes for medical device applications: published half-yearly snapshot of actual processing times by application and audit type tga.gov.au · TGA — varying your medical device or IVD ARTG entry: software transition variations carry a 3-5 business day target, and section 41JA or section 31 notices allow not less than 10 working days to respond

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against TGA publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:australia:class-i