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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)

6. Period of validity of licence and renewal of licence

 

(1) A licence issued in terms of regulation 5 is valid for a period of five (5) years from the date of issue.

 

(2) A licence referred to in subregulation (1) may be renewed by application to the Council.

 

(3) An application for the renewal of a licence must—
(a) contain at least the information or documentation referred to in regulation 5(1)(c), as the case may be;
(b) be accompanied by the prescribed fee; and
(c) be made at least 90 days before the expiry of the existing licence.