(This article was first published in Australasian Biotechnology 18(2), June 2008. - the official journal of AusBiotech)

Big changes are afoot at TGA as the Australian national regulator struggles to cope with workloads while nursing a hangover from the transition to new medical device regulations. The changes will see priority for speedier assessments of new devices and a wholesale redesign of TGA’s electronic lodgement portal with a move to true notification of Class I devices. On the international front a new MOU with Canada will allow TGA to conduct manufacturer audits in support of Canadian applications. These changes promise faster market access especially for Australian manufacturers, although there remains more to be done, particularly on implementation of 3^rd party assessment.

Newcomers split – to a fast(er) track

The absence of any grandfathering provisions in TGA’s new globally harmonised regulations meant the entire Australian inventory of medical devices required re-assessment prior to the sunset on the old regulations last October. Higher costs and much tougher reviews under new rules caused most manufacturers to wait till just before the deadline before submitting transition applications. The resulting overload forced TGA to pass new legislation allowing continued supply of existing devices pending re-assessment.

More importantly, applications for new medical devices were caught up in the very long queue of transitioning devices. For early stage medical device companies bringing a first product to market, the delayed assessments – often many months over target – were potentially fatal. Following repeated representations from AusMedtech, TGA has split the queue, establishing separate workgroups and management for assessment of new applications and aims to process all future new device applications within target times. AusMedtech will be monitoring TGA’s progress under the new arrangements – watch this space.

New DEAL - Class I take notice

In all major international markets, low risk (Class I) medical devices may be supplied direct to market based on manufacturer self assessment. Australia alone reviews Class I applications prior to grant of marketing approval. Even though these are largely administrative checks, the extra delays in marketing have proven costly, especially to emerging manufacturers. In the second half of 2008 TGA plans to begin roll out of a redesign of its ageing Device Electronic Application Lodgement (DEAL) web portal. The first stage will be a change to true notifications for Class I non-sterile/measuring function applications. Once the application is submitted, the device will be instantaneously entered onto the ARTG and approved for supply, with no review. When complete, the new portal will integrate medicine and device applications and manufacturing assessments, include much more extensive online help and provide access to all client information via a single login point. The redesign is being tested in conjunction with industry associations including AusMedtech.

Postmarket strengthened

Another important change is a beefed up Postmarket review process as counterpoint to the more streamlined premarket systems. Expect more rigorous review of company postmarket monitoring activities, more spot checks on devices and greater TGA attention to adverse events. A proportion of all notified Class I devices will be subject to random postmarket audit.

Unfinished Business

Australian Industry has long lobbied for 3^rd party assessment, the norm in most overseas markets, offering the potential for multiple market entry via a single assessor. TGA had committed to 3^rd Party as part of the stalled “Trans Tasman” ANZTPA negotiations however there’s still little sign of progress and this is very much unfinished business for AusMedtech, which will continue to press for introduction of 3^rd Party assessment of medical devices in Australia.