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South Africa- Updated Guideline on Classification of Med.Dev and IVDs & Medicines for use in PHU

Updated Guideline on Classification Of Medical Devices and IVDs


The aim of this guideline is to assist manufacturers, importers, distributors and wholesalers of medical devices and IVDs in the classification of medical devices and IVDs required for the licensing of manufacturers, distributors, and wholesalers and registration of medical devices or IVDs.


The types of medical devices or IVDs include all products classified as per the different Classes based on a risk assessment and intended use.


Check out the guideline for detailed Classification & explanation, by clicking this LINK



Availability of Medicines For Use In A Public Health Emergency


The purpose of this guideline is to guide how medicines that are not yet available in South Africa may become registered for use by, or authorized for sale to those who are affected by a Public Health Emergency (PHE).


Such applications for registrations or authorizations would be received, processed, and decided upon effectively, consistently, timeously and in accordance with the Medicines and Related Substances Act, 1965 (Act 101 of 1965), [“the Act”] and the General Regulations published in terms of the Act [“General Regulations”].


The processes encompassed in this document guide how applicants may position their applications to best facilitate the review of applications for the registration, or authorization of the sale of a qualifying medicine in response to a PHE.


Check out the guideline for detailed Classification & explanation, by clicking this LINK



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