01 Jun Regulatory Requirements for Medical Devices Electronic Instructions for Use (e-IFU)
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The Medicines and Related Substances Act No. 101 of 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 09 December 2016, provides for the regulatory oversight on labelling of medical devices, including In-Vitro Diagnostics (IVDs), in South Africa.
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Document Number:
MD03-2026/27
Version:
1
Date Updated:
08/05/2026
File Type:
www
Category:
Communication to industry