Each December Australia’s TGA reports statistics on its premarket and postmarket activities. So how long does it take for TGA to review a submission and what’s likely to happen if you have a postmarket event? We take a look at the latest numbers.
TGA offers conformity assessment as an option for all manufacturers and requires manufacturers of high risk devices with biological or medicinal components to undergo direct conformity assessment. Statistics show that all submissions were processed well within the required target time: with mean time for new assessments of 122 TGA working days (equivalent to around 6 calendar months) and 77 days for re-certifications or changes. But there’s a quirk in the statistics. TGA also publishes median figures. We don’t see the actual breakdown of all submissions but the numbers are apparently highly skewed – with much longer median times: 151 days for new assessments – suggesting most new submissions are biased towards longer processing, and 48 days for changes – suggesting these are mostly done in shorter times. (See here for an illustration of the interpretation of means versus medians and here for a longer discussion – beware you may never emerge from this statistical rabbit hole).
All well and good – but it’s worth noting that TGA allows itself very generous processing times. The TGA target for conformity assessment is 255 TGA days. That’s effectively a calendar year plus a week in the Australian Capital Territory and does not include “stop clocks” when TGA is waiting for manufacturer responses to review questions. Nonetheless TGA’s actual processing times are broadly equivalent to those of European Notified Bodies – which tend to complete a CE Conformity Assessment in around 6 calendar months (although anecdotal reports suggest that some European Notified Bodies are themselves struggling with backlogs at the moment). In comparison, the US FDA sets a target time of 90 days for a 510(k) and 180 days for the PMA process for the highest risk devices. FDA meets its target for over 98% of 510k submissions and PMA supplements (No summary data are published for full PMAs).
Registrations and application audits
The good news is that for most devices, TGA does not require direct conformity assessment but instead will accept an existing CE certificate in lieu of TGA assessment. For most of these devices, TGA will process the registration very promptly, with only the higher risk devices required to undergo an application audit involving a TGA desktop review of summary technical file documentation (principally clinical and risk reports).
For the January-June half year, TGA processed device application audits in mean of 82 TGA days (around four calendar months). For IVDs the news was much better, with application audits being completed in less than three calendar weeks.
Application success rates are high. Rejections are typically around 1% of applications received, and around 5% of lower risk device applications are withdrawn – this can be done during the review process if the manufacturer is unable to satisfy review questions. The notable exception is Class III and AIMD devices where rejections run at around 25%. These devices are all subject to application audit and anecdotal evidence is that most of TGA’s rejections arise out of inadequate clinical evidence – which is an area where TGA sets high standards.
|Class 1 IVD||
|Class 2 IVD||
|Class 3 IVD||
Class 4 IVD
Applications are declining
Notably there’s a steady fall in applications with the exception of Class IIb devices, which showed an increase in early 2015.
On the postmarket side – reporting rates are fairly constant – running at a little more than 3,000 a year. It’s also notable that TGA is clearly speeding up processing of incident reports – with mean process times falling from 59 to 14 days (all well within the TGA target of 90 TGA days). As for the consequences of incident reports: around a third are reviewed but no further action taken and the other two thirds are logged for trending.
It”s instructive to look at the “hard” regulatory outcomes from follow ups to Adverse events. Of the 1248 DIRs processed in the first half of 2015, outcomes included
- 80 (6%) Recalls, Hazard Alerts, or Safety Alerts.
- 11 (1%) amendments to the instructions for use.
- 5 product cancellations and 2 company warnings (0.6%)
- 22 manufacturing process/quality system improvements, and 3 changes to the design. (2%)
These numbers are not mutually exclusive but it’s likely that double counting is not high.
All in all 123 (10% of reports completed) resulted in substantive regulatory outcomes, plus there were additional referrals to postmarket review or audit teams.
Postmarket audit of automatic Class I registrations
Class I devices have been able to be registered within 24 hours by means of an on-line filing. However manufacturers are required to hold full Technical File data (including clinical evidence) for Class I devices and TGA audits these devices to check compliance. Audit rates are currently running at around 100 per 2400 annual Class I registrations – or around 4% of applications. Considering it’s a criminal offence to register a device for which evidence is not held – it’s not worth the risk of filing without the data in hand.
Caveat… this is old news
Actually a couple of caveats here:
- Let’s be clear: “latest figures” means published at the end of December… but these figures actually relate to performance in the year ending June 30 2015 – so they’re already 6 months old.
- The end of June 2015 saw the deadline for submission of Joint prosthesis up-classification submissions – as TGA re-aligned these devices to the European classification scheme – essentially upgrading from IIb to III. In the run up to the deadline TGA received an additional 523 joint up-classification submissions on top of the 182 other Class III submissions. This certainly affected the workload of the TGA reviewers and we would expect to see a blow out in the second half figures when they are eventually published. Having said that, this is a temporary blip, and most of the joint prosthesis submissions have now been processed so we would expect to see a return to trend in 2016.
TGA processes full conformity assessments in broadly similar times to a Notified Body CE assessment. However the option to use a CE certificate for devices which already have European approval (including devices manufactured in Australia) provides a much faster track. Higher risk devices still have to undergo an application audit – which adds an extra 3 months to the European certification process but avoids the need for a duplicate Australian Conformity assessment.
However devices not subject to mandatory application audit (Most IIa and IIb devices) are processed promptly. Recent experience in our practice has seen medium risk IIa and IIb devices processed in shorter and shorter times, usually within a few weeks and occasionally much faster. We recently broke our record with a Class IIb device approved in 48 hours :). it helps if the device submission is carefully prepared and key summary information provided in a cover letter.
On the postmarket side, only a very small number of Device Incident Reports result in recalls or hazard alerts and a similar number result in manufacturing or design changes.
The full set of statistical tables are available on the TGA website.
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