Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

What about the rest of the world?

 For the final session we will focus on requirements in other regulated markets

The Organisation for Professionals in Regulatory Affairs

19

There are no registration requirements so I am OK?

 No! ● Import into countries generally requires import permit (tariffs) ● Initial application often requires labelling in local language and proof of compliance with other standards plus CFS ● High risk devices are most likely to attract attention ● WHO prequalification  Other items often required ● Letter of Authorisation

The Organisation for Professionals in Regulatory Affairs

20

10