The idea, in general, is that there are two basic kinds of regulatory systems:

A) Systems that document the current snapshot of the device’s design/manufacture/risk profile, etc.

B) Systems that document the whole history of the device’s design/manufacture/risk profile from development up through marketing

Both systems nowadays require post-market surveillance and will increase this burden as time passes.

The EU, Australia, and countries like that have System A. Countries like the US, China, Japan, Brazil have System B, which relies on Design Controls.

In my opinion it started this way because System A reflects a regulatory system that focuses on Trade and System B reflects a regulatory system run by a Human Health and Services organization, i.e. public health. Naturally, you should see that both of them overlap and they will start overlapping more and more as they begin to converge.

There’s a System C as well…. little or no regulatory. You don’t have to go as far as Africa to see this type. Look at India for an interesting case.