Australia via 510(k): TGA – recognises US, Canadian and Japanese approvals with MDSAP
Australia’s regulatory system is modelled very closely on that of Europe. This equivalence of requirements and assessment pathways has allowed TGA to leverage prior CE marking to grant Australian device licenses. In fact, around 95% of devices registered in Australia are approved based on the presentation of a CE certificate. For higher risk devices including all implants, TGA conducts additional desktop reviews of key data (especially clinical evidence) before registration. However, almost all lower risk Class IIa and most Class IIb devices are approved in Australia based on the CE certificate alone.
Around 95% of devices approved in Australia are approved based on the presentation of a CE certificate.
Comparable International Regulators
A review of Australian regulation in 2015 recommended that TGA should explore similar recognition of prior regulatory approvals from other similar regulatory agencies. TGA has been exploring options for some time and, not surprisingly has looked to other members of IMDRF as alternate options. Among the two other English language regulators in IMDRF, Health Canada – which also has a regulatory system closely modelled on the European was an obvious choice (TGA has in fact been accepting Canadian Licenses to support IVD registrations for some years). The US FDA was more problematic given the very different regulatory classifications and review processes employed in the US.
In a surprising development, TGA has included Japanese licenses within the list of overseas approvals to be recognised. For higher risk devices, TGA will still require application audit reviews of key clinical and other technical data. It will be necessary for manufacturers to translate any such documentation not already available in English.
And the answer is – MDSAP!
The challenge for TGA has been how to ensure the international reviews cover off both the regulatory review of design safety and performance, as well as manufacturing audit (TGA requires ISO 13485 compliance).
The key to this new door is having not only the international regulatory approval but also a quality systems audit under the new Medical Devices Single Audit Program (MDSAP). MDSAP audits specifically include checks that the manufacturer complies with regulatory requirements in all MDSAP-partner markets supplied.
Following Health Canada’s adoption of MDSAP as a mandatory requirement for Canadian approvals, TGA placing MDSAP in the centre of this new international recognition scheme will provide a further boost to the importance and value of MDSAP certification.
Application Audits – comparing apples with apples
TGA has always required a desktop review of higher risk devices supported by CE certificate – calling in Risk Assessments and Clinical Evaluation reports, and at times drilling down to other data. This approach will continue under the new arrangements. In summary, as alternates to current acceptance of CE certification, TGA will require two pieces of evidence:
– Product Assessment Evidence Japanese Pre-market certificate, Canadian Device License, FDA 510(k) (traditional or de novo) or PMA summary.
– Manufacturers evidence either a CE certificate (as currently accepted), Japanese QMS certificate, Canadian CMDCAS or MDSAP certificate.
There is an important caveat here: apples must be compared to apples – international licenses must be issued for equivalent risk classes (e.g. a Canadian Class III license is required to support an Australian Class IIb registration). This is particularly problematic for US-approved Class III and Active Implant (AIMD) devices – for which TGA will accept a US PMA but not a 510(k) approval. Given that US PMA applies only to a small subset of high-risk devices, there will be many types of Class III and AIMD which will not be able to utilise US 510(k) clearances for Australian registration.
Abridging Direct TGA Conformity Assessments too
This leveraging of international reviews is also applicable to those devices required to undergo direct full TGA conformity assessments. Currently, TGA requires direct assessments for Class III devices which contain integral medicinal or biological origin materials. Australia is a long way Down Under and TGA manufacturer audits have always been a costly exercise in long-haul travel.
with darkening regulatory clouds in Europe, … manufacturers may find a warmer welcome in the Southern Hemisphere
TGA has indicated it will take into account international manufacturer assessments to abridge their own assessments. In particular, TGA will accept or consider European design examinations and European quality system audit reports (both MDD as well as MDR/IVDR reports) as well as MDSAP audit reports.
TGA has abridged conformity assessments in the presence of European reviews for some time, this latest announcement formally codifies these practices and extends them to acceptance of MDSAP reports (and eases the jetlag for TGA auditors).
Welcome Relief to MDR Woes
There are darkening regulatory clouds in Europe, as the industry and regulators alike struggle to cope with the enormity of the transition to the new EC Medical Device and IVD Regulations (MDR, IVDR). There are lengthy queues just to commence Notified Body reviews (more than a year in some cases). Most Notified Bodies have indicated they will cease assessing to MDD at some time next year – in some cases up to a year prior to the end of the transition period in 2020. This means that some manufacturers may find themselves with a (hopefully temporary) and very painful hiatus in their CE certifications. Others are delaying European approvals until things settle down.
TGA’s new pathway presents perhaps a few rays of sunshine. Certainly, manufacturers holding the US, Japanese or Canadian approvals will enjoy much greater flexibility in their approaches to Australian regulatory approvals and perhaps find a warmer welcome in the Southern Hemisphere.
Useful Link: Detailed tables of acceptable overseas evidence (TGA website)
We recently presented a webinar on leveraging international approvals for TGA registration. Click here to view.
Looking to fly south for warmer weather? We are skilled in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us to discuss your needs and how we can help. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)