In these days of harmonisation and mutual recognition, who has the best device regulatory passport?

In these days of harmonisation and mutual recognition, who has the best device regulatory passport Brandwood Biomedical Global Medical Device and IVD Regulatory Services

It’s almost 30 years since the establishment of the Global Harmonisation Task Force (GHTF), now replaced by the IMDRF.  The GHTF essentially produced guidances built on the European regulatory model of conformity assessment against essential requirements and harmonised standards and this model spread around the world into many more jurisdictions including markets as diverse as Canada, Australia and Singapore. The elements of the GHTF found their way into many more places e.g. both China and Japan have adopted risk-based classification schemes which borrow from the concepts of the GHTF.  And there is increasing convergence in use of international consensus standards (including widespread use by US FDA).

All this harmonisation is meant to be all about regulators giving each other a helping hand. A regulatory review in one market can be taken into account to shorten the review in another market. This works best if both the regulators concerned are using the same or similar processes and common technical standards.

Leveraging CE Down UnderLive Webinar In these days of harmonisation and mutual recognition, who has the best device regulatory passport Brandwood Biomedical

Here in Australia, we see harmonisation used to its fullest extent. Australia’s TGA has a regulatory regime very closely modelled on that of Europe. This allows TGA to directly accept a CE certificate as fully equivalent to its own regulatory review for most devices. And more than 90% of devices sold in Australia are registered based on the CE certificate alone, and most of the rest are approved based on CE certificate plus a desktop review (which TGA call an application audit) of key data including clinical evidence.

More than 90% of devices sold in Australia are registered based on the CE certificate alone.

Many other smaller regulators (think Singapore, Saudi Arabia, Taiwan, Malaysia) rely heavily on leveraging pre-existing approvals to abbreviate their own regulatory reviews. And given that most of them operate GHTF/European models, the CE mark has become a de facto global regulatory passport for medical devices.

Can we continue to rely on Europe?

But there is a hiatus in Europe. The big step up in regulatory requirements under the new MDR and a reduction in Notified Bodies from more than 80 to around 25-30 means regulatory gridlock in the European Union. Notified bodies are becoming more choosy about their selection and acceptance of new clients and there are long delays – with some Notified Bodies reporting waiting times of 1 -2 years to take on new projects.

The CE is going to become a lot harder to get. It’s like the passport office has shut up shop for a while…

Those regulators who have relied so heavily on CE mark may have to find new ways to recognise international approvals – because in the absence of prior CE, they simply won’t have the resources or experience to start doing large numbers of direct assessments themselves.

the CE mark has become  a de facto global regulatory passport for medical devices – but it’s like the passport office has shut up shop for a while

TGA casts a wider net

Australia’s TGA has been actively looking at this for some time – initially in response to a recommendation of a review into TGA regulation, but more recently lent a new urgency as the inevitable delays in Europe have come into focus.

TGA conducted a wide consultation on recognition of other international approvals. The agency is clearly looking at direct recognition of reviews by other IMDRF regulators, starting with the English speaking US FDA and Health Canada.

Canada uses a GHTF/European model with closely similar classifications, so acceptance of Canadian licenses should be relatively straightforward.

Is FDA really that different?

But FDA 510(k) processes are, on the surface, quite different.

So how might TGA or others use a 510(k) to support Australian registration? Anyone who has tackled 510(k) will know that, yes – the approach is based on the notion of comparison with a predicate device, which seems quite different to the first principles approach of a European Conformity Assessment.  But FDA’s review also takes a primary look at safety and effectiveness data, and more and more 510(k) reviews (>15%) require direct clinical trial evidence to support these medium risk devices.

Take a look at the standard contents list of a 510(k): The first column is the US FDA administrative content and the second the Technical content of the submission. The requirements cover all of the design verification testing and risk management – extracted straight from the Design History File and also present in the European/GHTF Technical File.

FDA 510k – closer to a European Technical File than you may think

1.       User Fee Cover Sheet

2.       Submission Cover Sheet

3.       510(k) Cover Letter

4.       Indications for Use Statement

5.       510(k) Summary

6.       Truthful and Accurate Statement

7.       Class III Summary/Certification

8.       Financial Certification or Disclosure Statement

9.       Declarations of  Conformity and Summary Reports

10.   Executive Summary

11.   Device Description, Risk Assessment and Design information

12.   Substantial Equivalence Discussion

13.   Proposed Labelling

14.   Sterilization and Shelf Life

15.   Biocompatibility

16.   Software

17.   Electromagnetic Compatibility and Electrical Safety

18.   Performance Testing – Bench

19.   Performance Testing – Animal

20.   Performance Testing – Clinical

Similarly, there are parts of a European assessment which borrow from FDA’s way. The upgraded requirements for clinical evidence require direct comparison with predicate devices – a concept straight out of the 510(k) paradigm. And both jurisdictions require product development under design controls for medium to high-risk devices. (FDA is actually somewhat stricter than Europe here – mandating design controls for all Class II devices). So perhaps the Technical reviews aren’t so different after all. What’s really needed is to increase the mutual understanding between regulators of each others process, and how they each go about their review of the common technical dataset.

Australian registration based on FDA review

So how might it work in Australia? It seems a given that TGA will want to see at a minimum an ISO 13485 or an MDSAP certificate to show that the manufacturer has things under adequate control. Then it will boil down to what evidence of device compliance is required. TGA already has a well-established application audit (desktop review) process.  It uses this extensively for IVDs – where the European Directive does not require CE marking for most IVDs.  For IVDs TGA accepts an ISO 13485 in conjunction with review of high-level validation and clinical data.

But many US firms don’t have CE or ISO 13485. However, TGA already accepts FDA inspections of medicines GMP – where TGA enjoys direct access to FDA’s inspection database.

So it’s not hard to imagine an arrangement where TGA may combine review of an FDA Establishment Inspection report with a review of key elements of a PMA or 510(k) dossier. Time will tell, and we are anticipating an imminent announcement of the outcomes of the TGA consultation process.

Watch this space – or better still, join me in a  view our recent webinar where we look at the current processes in Australia, how TGA is reforming its processes and may leverage US regulatory approvals.

Need help with TGA regulatory compliance?  We are experienced in all aspects of TGA regulatory regulations – including using international data to gain Australian registration.  Contact us for a free, no obligation discussion.  Email [email protected] or call us:

1 888-271-5063 (US toll free)    ♦   400-842 7017 (Beijing – toll free)   ♦    +61 2 9906 2984 (Sydney)


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