Australia medical device regulatory resources

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