Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)27. Transitional arrangements regarding unlicensed manufacturer, distributor and wholesaler |
| (1) | A manufacturer, distributor or wholesaler who, at the time of the commencement of these Regulations, sells medical devices or IVDs in the Republic is, subject to regulation 5, considered to be trading legally. |
| (2) | The Council must issue a notice in the Gazette calling for the licensing of unlicensed manufacturers, distributors and wholesalers, which notice must stipulate the conditions and time periods for licensing and that, during the process of licensing, the unlicensed manufacturers, distributors and wholesalers are considered to be trading legally. |