Europe is changing… but what about Down Under? How will Australia’s TGA manage it’s own substantial reform processes while continuing to rely for most approvals on CE certifications? Can TGA maintain alignment with Europe?
Over the course of 2016, we’ve been inundated with information around the introduction of the Medical Device Regulation (MDR) in Europe, new revision of ISO 13485, Brexit, and the implementation of MDSAP. Australia has continued to work under the existing arrangements, which rely heavily on recognition of CE certificates granted under the current Medical Device Directives, but how long can this last? The Australian Therapeutic Goods Administration TGA publishes annual statistics of performance. These provide a fascinating insight into the agency’s workload and the extent of reliance on European certification.
TGA’s 2016 Statistics show that:
- 2,685 Class I medical device applications were automatically included on the ARTG with no TGA review
- 734 applications for medical devices were subject to TGA application audit – a desktop review of summary safety and performance data.
- 2,112 applications for devices of Class I(s)/I(m) IIa/IIb/III and AIMD devices were included on the register with no further review by TGA.
The TGA statistics don’t separate out these locally assessed devices in their ARTG inclusion statistics. So to get a clear picture, these figures must be adjusted for those devices which are subject to a direct complete Conformity Assessment by TGA. TGA approves around 150 direct conformity assessments each year. Devices from these assessments will be included in the 2,112 ARTG inclusions made with no further TGA review. But assuming there’s roughly one device inclusion per direct conformity assessment, that means that roughly 95% of device approvals in Australia are based on prior European approval (see chart). Almost 2,000 devices – or almost 70% of Australian device assessments are based on acceptance of CE certificate alone – with no technical review by TGA.
That heavy reliance on Europe is predicated on Australia’s requirements being very closely similar to those of Europe. TGA is a small agency – with perhaps fewer than 100 medical device staff. The acceptance of CE certification from the time of the introduction of the current regulations in Australia in 2002 has allowed TGA to manage their limited resources.
However, the European system is changing, with adjustments to assessment processes, requirements for evidence and device classifications. There’s considerable doubt about how easy it will be for Europe to make the transition to the new regulations and whether this will mean delays in approvals or even a shakeout in the European market with some devices losing their CE status. So the road ahead looks more than a little challenging!
In Europe the changes mean additional requirements for manufacturers, including increased mandatory reporting, and more work for Notified Bodies who will also be increasing the scrutiny they apply to the manufacturers. The introduction of additional requirements for Class llb and lll devices mean existing clinical data may need to be revisited, and possibly additional clinical trials may be needed.
As most of the Australian industry would be aware, TGA is also in discussions with industry through a large number of current consultations arising from the recent Expert Review of medicines and devices regulations. These include proposals for an expedited pathway for innovative devices, recognition of other international approvals other than CE and introduction of Australian Designated Conformity Assessment Bodies (CABs).
The question is how will all this local reform be integrated with the changes in Europe – on who’s CE certifications TGA so heavily relies for expedited approvals here in Australia in ways that will minimise impacts on both regulator and industry in Australia
Indeed – it’s questionable if this is even the right time to be looking at additional changes to our regulatory framework, given the pace of regulatory reform in the larger international markets. (For manufacturers in a global devices industry, the next few years will be challenging in the extreme with so many reforms taking place in so many markets. The risk is that for a small market like Australia, it will be all too hard for some participants. Will manufacturers who are stretched for resources to meet these intensive new EU requirements, still look to enter what is considered a small market which is also introducing not only increased scrutiny with the use of TGA–designated CAB’s but also additional costs?
These questions can and will need to be considered by government and industry to ensure Australia continues as a technically advanced nation for the Medical industry.
Confused by all this change? In these uncertain times, it’s essential to stay up to date, and ensure your source of regulatory information is as close to the flame as possible. At Brandwood Biomedical, we invest substantially in our participation with industry associations and regulators so we can ensure our clients are as up to date as possible, and be prepared for changes long before they arrive. If you’d like to discuss your current regulatory strategy and whether its right for the times contact us here or email email@example.com or call our Sydney office on +61 2 9906 2984.