Yes it does make sense in the general case.

In the approved countries a regulatory body has had to approve this as a medical aid. If medical aids etc did not have to be approved then things that actually hurt and kill people could be sold as medical aids.

The issue here is that this case appears to be a non damaging aid and so it looks silly to ban it. But regulations have to work otherwise they are of no use.

The issue here is either regulators in other countries are slow or in the worst case Apple has not applied for approval.