As the festive season quickly approaches, we find that some of the most important things are put on hold. However, now is actually the best time to ensure all your regulatory requirements are being met to allow for a clear and hassle-free holiday period!
Devices included on the Australian Register of Therapeutic Goods (ARTG) carry several standard requirements and ongoing responsibilities with which the sponsor must comply if their approvals are to remain valid. These requirements involve the key players in the medical device supply chain, including manufacturers, sponsors and distributors, sharing information and otherwise cooperating to develop effective, contractually-backed relationships. In our experience, we have seen many breakdowns in these requirements, where failure to address the requirements of one or more necessary parties has resulted in significant consequences. And don’t think this only applies to Australia. Most established regulated jurisdictions have similar requirements.
As we all know, a robust Technical File should support every approved device. However, given that the majority of devices supplied in Australia are registered on the basis of European certification, the limited premarket scrutiny of the primary technical documentation often manifests an assumption by the Sponsor that there are similarly limited postmarket responsibilities. However, this isn’t the case, and a direct assumption by the TGA is that every Sponsor will have on file (or immediate access to) technical documentation for the device. The ease with which this requirement is met is largely dependent on the nature of the relationship between Sponsor and Manufacturer; where the access to such information can be readily impeded by language, cultural and geographic barriers.
While it is a requirement that this documentation is available if ever requested, it is also required that this information be current. If the TGA can’t find evidence of regular review and updates to your technical documentation, as a result of internal changes, revised regulations or standards, post-market performance and other market feedback, they’re likely to start investigating further and auditing for compliance.
Conditions of entry on the ARTG isn’t limited to holding and maintaining technical documentation. The regulations, as set out in Part 5, Division 5.2 (5.9 to 5.12) of the Therapeutic Goods (Medical Devices) Regulations 2002, require Sponsors to control and maintain distribution records for certain devices, ensure storage and transport in accordance with the device’s labelling and most importantly, handle complaints and report adverse events to the TGA; all of which may be stumbling blocks for the unprepared distributor and manufacturer.
In summary, although the required activities of Sponsors are widely considered to revolve solely around vigilance and event reporting, Sponsors of medical devices in Australia have a broad set of requirements with which they need to comply if they are to maintain valid ARTG entries. It’s critical that Sponsors, as well as their manufacturers and distributors, are aware of these requirements, their practical implications and the regulatory consequences associated with failures to comply.
Here at Brandwood, we service the medical technology industry at all stages of the device life cycle. If you’ve found yourself struggling with the breadth of post-market requirements, or if you just need a little bit of help keeping house, please get in contact with us at email@example.com or call our office on +61 2 9906 2984 for a free no obligation conversation.