A couple questions regarding South Africa:
1. Can anyone recommend a reliable importer in South Africa? From what I've read, our device would be considered a Class B device which requires importation by a licensed company local to South Africa. Our product is software, so we won't be shipping physical product, if that makes a difference.
2. What is really going on with South African Medical Device regulation? I've read about the transition to SAHPRA and the whole system seems to be recommendations and somewhat of a moving target as far as requirements and enforcement.
Thanks for everyone's contributions to this board.
------------------------------
Timothy Roloff
Sr. Regulatory / Quality Engineer
Pewaukee WI
United States
------------------------------