How do you identify what standards a country recognizes outside of FDA, EU, Health Canada

[Ellison]

Good Morning,
My current company is slowly becoming more globally sold. How do you identify what standards a country recognizes outside of FDA, EU, Health Canada, and in some sense Japan? I know that TGA's expectation is that you use the most recent publication of a standard to be "state of the art" but what about countries outside of those regions (Brazil, China, India, ect.)? How do you know what standards they will accept with submissions? Do you go with the most recent publication when a country does not have a list?

 

[Marcelo]

If the regulatory system has a process for systematic recognition of standards (such as the FDA and EU0 you just need to access the recognition database or list. If the country does not have such a process, you would need to verify if the regulations from the country mention standards (also take care with countries such as Brazil which has some specific certification processes linked to regulatory requirements).. Otherwise, the best bet is to use the most recent publication.