ROW Approval Matrix

[Dobby1979]

Hi All.

I am trying to find some information on the regulatory approval required for countries around the world, notably Australia and Canada at the moment. Does anyone have any kind of simple matrix that demonstrates the complexity involved with different countries? Do they favour 510(k) or CE Marking etc?

Any help is welcome.

Thanks.

 

[yodon]

510(k) is unique to US / FDA - and every country is different. Emergo (no interest) maintains a good list here: Resources

 

[Ronen E]

You can leverage EC certification (CE marking) or a cleared 510k to fast-track clearance in Australia (the former more than the latter). You'll find all the details on the TGA's website.

No offence, but the Y in DIY means "Yourself".