This is not my area of expertise, but in speaking to Regulatory Affairs people when I was working in the field, most of the EU and some of Asia base their regulations on the US FDA, or at least have very similar regulations. In addition to FDA audits, we were also periodically audited by the regulatory bodies of other countries.<p>However, in many countries, enforcement is lax, so you get lots of devices that don&#x27;t come close to meeting whatever regulation is in place.