Posted 21 December 2016
The medical device and IVD regulations have been published as Government Notice No. 1515 in Government Gazette No. 40480, dated 9 December 2016, and are accessible at http://www.gov.za/sites/www.gov.za/files/40480_gon1515.pdf
(also available on CamCheck as a pdf, and converted to text)
The Sepedi version is at http://www.gov.za/sites/www.gov.za/files/40480_gon1515_pedi.pdf
These are final regulations, for implementation and the ToC is as below:
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