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Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)

Regulations

Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)

9. Information that must appear in the register for medical devices or IVDs

 

The medical device or IVD register must, in respect of a registered medical device or IVD, contain the following information:

(a) The name and group or family and the make and model, where applicable, of the medical device or IVD;
(b) the registration number allocated to the medical device or IVD;
(c) in the case of a combination device, the name and quantity of the scheduled substances or biological substances in the medical device;
(d) the intended purpose or use of the medical device or IVD;
(e) the name of the holder of the certificate of registration;
(f) the name and address of the original manufacturer;
(g) the date of registration of the medical device or IVD;
(h) the conditions of registration of the medical device or IVD;
(i) the class of medical device or IVD; and
(j) the nomenclature system code allocated to the medical device or IVD.