In Australia, TGA has specific requirements for postmarket compliance which extend far beyond conventional adverse event reporting. We take a look at the bigger picture.
Australia’s Therapeutic Goods Administration (TGA) recently reminded sponsors (license holders) and manufacturers of their ongoing responsibilities to ensure that devices included on the Australian Register of Therapeutic Goods (ARTG), remain compliant. Unfortunately, some Manufacturers and local Sponsors consider requirements to be limited to Adverse Event reporting. The truth is that postmarket compliance is much more comprehensive, and requires establishment of clear processes, backed by contractual relationships to ensure that all parties (sponsors, manufacturers, distributors) play their part. In our consultancy practice, we repeatedly see examples of postmarket process failure where the processes were either non-existent or were poorly defined or documented or not actively maintained.
Laying the Foundations
Long term compliance relies on a solid foundation of premarket preparedness. The great majority of devices supplied in Australia are registered on the basis of CE certification, with limited premarket scrutiny of the primary technical documentation. This can lull naïve sponsors into a false sense of security. Underlying this co-regulatory compact is a requirement for manufacturers to hold full Technical Files containing evidence of compliance, a TGA power to compel manufacturers to produce the evidence at any time and strict expectation that it be produced promptly, usually within 20 days of TGA’s request and rarely are extensions granted.
Prior to the submission of any application, Sponsors and Manufacturers should understand their responsibilities with regard to Technical Files and particularly the idiosyncracies in TGA regulations which mean that some of the documentation has to be for Australia. In particular, TGA expects to see Essential Principles checklists following the GHTF format (not the EC Essential Requirements), a specific written justification of classification against the Australian classification rules, a Clinical Evidence report satisfying TGA’s specific requirements and an Australian Declaration of Conformity, again to TGA format, a European declaration won’t do. Failure to produce information to TGA within the deadline is a ground for deregistration. So it’s essential that local sponsors make sure that the evidence exists prior to registration and have contractual relationships with their overseas manufacturers to produce this documentation promptly on TGA request.
Keeping up the Maintenance
A solid foundation isn’t enough alone. Another major failure we see all too often is failure to keep Technical File information current. Most of the documents required by the regulator would be impacted by internal changes such as design improvements and external changes such as revised standards. Post Market data such as complaints and other sources of market feedback should also be considered. It’s particularly important for the key documents such as risk management files and clinical evidence reports to be kept up to date. It’s far too late to attempt an update after receipt of a 20-day notice. IF TGA can’t see evidence of regular review and consideration of recent information they’re likely to then consider if appropriate risk mitigations have been implemented, and start digging deeper.
In summary, although vigilance activities such as Adverse Events and complaint feedback is critical for Sponsors and Manufacturers, the maintenance of supporting evidence is just as critical in ensuring the device can be continuously supplied to the market. It’s important for any jurisdiction that the Technical File supports the local requirements. That means that it’s vital to understand those local wrinkles and idiosyncracies, and to make sure that everyone understands the requirements and all the parties play their part in keeping house.
Struggling with the housework? Not sure of the rules? We can help with your pre- and post-market compliance in Australia (and in other markets – ask us about our local experts in our China office). We can also act as your local sponsor and take care of it all for you. Contact us at email@example.com or call our Sydney office on +61 2 9906 2984 or Beijing on +86….