Australia medical device registration timeline

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

Since October 2020 Class I applications have run through the same assessment and audit-selection process as every other class, so "notification only" no longer describes the route

In the published half-yearly snapshot, Class I applications completed without audit took a median of 1 and a mean of 3 TGA days; those selected for audit took a median of 11 and a mean of 31

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

Non-Class I applications completed without audit took a median of 9 and a mean of 10 TGA days in the published snapshot

Australia is unusual in splitting conformity assessment from market authorisation, which is what allows overseas certification to be used in place of a TGA assessment at this class

Same 20-working-day statutory inclusion clock; audit selection is more likely at this class and suspends any published limit

Level 1 compulsory audits ran to a median of 14 and a mean of 27 TGA days in the published snapshot, and Level 2 compulsory audits to a median of 161 and a mean of 174

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

Non-IVD Level 2 application audits: TGA expects the first round of specialist assessment within 100 working days, and will explain a revised timeframe if it cannot meet that

Sponsor responses to a s41JA notice or a Proposal to Refuse are due within 20-40 business days depending on complexity, and that time does not count against TGA targets

The published targets replaced an older blanket 60-working-day audit target that TGA says was arbitrary and not consistently met

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

These are TGA days only. TGA estimates 40-100 business days of applicant time on top, for a total of roughly 10-15 months

Segments inside the clock: pre-assessment within 30 business days, then all component areas aim to finish round 1 within 100 business days, with 20-40 business days for each applicant response round

The application clock stops while the applicant holds the file, and can be stopped by mutual agreement in extenuating circumstances — but not for holidays, missed TGA requests, or time spent translating documents or generating missing information

An on-site QMS audit report is issued within 60 days of the audit; MDSAP or EU notified-body audit evidence can substitute a desktop assessment for the 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

Target 190 business days with TGA and a maximum of 225, plus 40-100 business days of applicant time, for roughly 12-16 months in total

Still bounded by the same 255-working-day Regulation 4.3 cap

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

Substantial changes to an existing certificate are not recertifications: they run on the new-or-substantial target of 160/200 business days