South Africa New Draft Regulations - Regulation Gazette No 37579, 22 April 2014

M

medgar

#1
Hi

There are new draft regs (Regulation Gazette No 37579, 22 April 2014, Vol 586 No 10180) in South Africa published on 22-Apr-2014 for comment.

http://www.greengazette.co.za/docum...pril-2014-vol-586-no-10180_20140422-GGR-37579


Looks like they are proposing a they are proposing a four-tier, risk-based device classification system—Class A (lowest risk) to Class D (highest risk) and an Authorised Rep.

The data package requirements looks like a standard STED.

Previous reforms to the regs have not progressed so it will be interesting to see if these go ahead.

Does anyone have any insight into how these regs have been received in South Africa?
 
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X

xgg810116

#3
I also want to know the details!

Previously, only Electromedical devices are requested to register in South Africa.[FONT=&#23435][/FONT]
 
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