Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Sources of Information

 Regulator websites ● FDA, HC, TGA  Consultants ● Emergo ● Arazy ● Pacific Bridge Medical

The Organisation for Professionals in Regulatory Affairs

43

Conclusions

 Join regulatory working groups ● Good regulation needs to be pragmatic

● Don’t be shy showing your knowledge, but remember, patient first!  Use the RCP as the basis for work especially in regulated countries  Set files/processes up to cover top 5 country requirements (including Japan) and build others from there (use IMDRF TOC)  Other countries with no regulations may still have requirements

The Organisation for Professionals in Regulatory Affairs

44