What can we learn from… Australia?

What if the interaction with regulators was more personal?

This week, I was interviewed as part of the Therapeutic Goods Administration's research for improving health software regulation.

Since we registered a SaMD client in Australia, we were contacted to take part in a 1 hour call with ORIMA Research on the TGA's behalf. We had the chance to discuss our experience and to give suggestions on what would help other digital health companies enter the Australian market compliantly, for example:

🔍 how do companies find out whether they are regulated?
🔍 what is key for them to know in order to navigate the regs?
🔍 what's clear / unclear in the regs?
🔍 what could be attracting digital health companies to Australia?
🔍 what would put them off from doing it compliantly?

I would love to see the EU doing the same. But then, in practice, who? The European Commission? The national Competent Authorities? The Notified Bodies? Team-NB? MDCG? It gets complicated before even starting..

Yes, sometimes the EC issues calls for comments on certain regulations. The problem I have with this is a) the free-text format, which is an invite for whining and venting, and b) the lack of accountability, i.e. does anyone read it? what happens with it?

In contrast, I really appreciated:
🌟 The structured discussion format, still with some liberty to digress,
🌟 The face-to-face personal interaction, which encourages trust,
🌟 Knowing a report with clear actions will come out of it and disseminated.

Kudos to the TGA and lovely experience chatting to Jack Disher at ORIMA.
We look forward to the report!