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Medicines and Related Substances Act: Medicines Control Council: Registration of medical devices and IVDs

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Medicines and Related Substances Act: Medicines Control Council: Registration of medical devices and IVDs

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The Medicines Control Council by virtue of the powers vested in it by section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and Regulation 27(2) of the Regulations relating to Medical Devices and In Vitro Diagnostics (IVDs) has by resolution resolved that, with effect from the date of publication of this notice, all unlicensed manufacturers, distributors and wholesalers of Medical Devices and IVDs are required to submit applications, as the case may be, for a licence to manufacture, wholesale or distribute medical devices and IVDs.

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