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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)

15. Method of taking samples during investigation, certificate to be issued and reporting of analysis results

 

(1) An inspector may, take a sample, or any quantity of samples, of a medical device or IVD for purposes of testing, examination or analysis by a person suitably qualified within his or her professional scope of practice, such as a clinical engineer, technician, or pathologist.

 

(2) The sample or samples contemplated in subregulation (1) must—
(a) be taken in the presence of the person who is in charge of the medical device or IVD, or in the absence of that person, in the presence of any witness present;
(b) be taken and stored in such a manner as to ensure its integrity during the entire examination process of the sample;
(c) be packed and sealed and suitably labelled or marked in such a manner as its nature may permit; and
(d) be transmitted by any suitable means to a person suitably qualified within his or her professional scope of practice such as an analyst, clinical engineer, technician or pathologist, together with the certificate signed by the inspector, a copy of which must be issued to the person contemplated in paragraph (a) by the inspector at the earliest possible time.

 

(3) The suitably qualified person referred to in subregulation (1) must, as soon as possible after receipt of the sample, test, examine or analyse the sample and report the results of the test, examination or analysis.

 

(4) An inspector referred to in subregulation (1) may, in terms of these Regulations, take a sample during a routine inspection, from a manufacturer, a distributor, a wholesaler or retailer, for testing, examination or analysis.

 

(5) Despite subregulation (1), the Council may require a holder of a certification of registration to supply the Council with a sample of a particular medical device or IVD in order to test, examine or analyse the sample.

 

(6) A certificate issued in terms of this regulation or a report contemplated in subregulation (3), must be submitted to the Registrar within 7 days from the date of issue.