For most companies in the BME industry, they operate globally. This means that they have to adhere to all of those nation’s regulatory agencies. There are agencies such as EMEA, CFDA, ANVISA, etc. that come to the US to ensure regulatory compliance. Not all companies that try to sell to the US have such regulations. For the US, companies follow a sort of “de facto global regulations”. This is so they can sell to the largest market possible. Will it be written into law? Probably never. However there are “global requirements” that most agencies require for companies to follow because they are common between the agencies.