17 Jul Medical Device Establishment Licence Renewal Process
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The Medicines and Related Substances Act 101 of 1965, as amended, read together with the Regulations related to Medical Devices and IVDs, provides for the regulatory oversight of Medical Devices, including In Vitro Diagnostics (IVDs) in South Africa. In terms of Section 22C(1)(b) of the Medicines and Related Substances Act 101 of 1965 (also referred to as the Medicines Act)and Regulation 5 of the Regulations relating to Medical Devices and IVDs (also referred to as Medical Devices Regulations),
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Document Number:
MD06-2025/2026
Version:
1
Date Updated:
17/07/2025
File Type:
pdf
Category:
Communication to industry