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

Regulations

General Regulations

Registration of Medicines

19. Transfer from register for medicines to register for medical devices or IVDs

 

(1) The Authority may transfer information pertaining to the registration of a medicine from the register for medicines to the register for medical devices or IVDs following an application for such transfer from the holder of the certificate of registration of the medicine.

 

(2) An application for transfer from the register for medicines to the register for medical devices and IVDs must be—
(a) made to the Chief Executive Officer by the authorised representative;
(b) on the application Form obtainable from the office of the Chief Executive Officer; and
(c) accompanied by—
(i) the applicable certificate of registration;
(ii) the reasons for the transfer;
(iii) proposed classification of the medical device or IVD; and
(iv) the prescribed application fee.

 

(3) If the Authority approves the application submitted to him or her in terms of subregulation (2), the Chief Executive Officer shall make the necessary entries in the register relating to the medical device or IVD, cancel the existing certificate of registration and issue a new certificate of registration in the prescribed Form to such person.

 

(4) For the purposes of subregulation (2)(a) "authorised representative" shall be as defined in the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) in terms of the Act.