Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)17. Adverse event reporting and vigilance for medical devices or IVDs |
| (1) | An authorised representative or a holder of a certificate of registration in respect of a medical device or IVD must inform the Council, in the manner and within the time frame determined by the Council, of a suspected adverse event, reported to him or her, occurring as a result of the use of the medical device or IVD. |
| (2) | An authorised representative or a holder of a certificate of registration referred to in subregulation (1) must— |
| (a) | within the time frame determined by the Council, after receipt of the report referred to in subregulation (1), inform the Council of the steps to be taken to address the adverse event; |
| (b) | whenever requested by the Council, conduct a concise critical analysis of the safety and performance of the medical device or IVD and submit the results thereof to the Council within a specified time frame; and |
| (c) | in the case where, after receipt of the results referred to in paragraph (b), the Council determines that the medical device or IVD may not be safe to use, submit to the Council, if required to do so— |
| (i) | case reports of suspected medical device adverse events in respect of the medical device or IVD; |
| (ii) | where applicable, medical device or IVD usage figures, periodic safety update reports and performance studies; and |
| (iii) | any other data requested by the Council. |
| (d) | keep and maintain or have access to records of the adverse event data in respect of his or her or its medical devices or IVDs. |
| (3) | Nothing in this regulation may be interpreted as prohibiting a person from reporting an adverse event to the Council. |
| (4) | Despite subregulation (1) or (3), a user who becomes aware of an adverse event caused or suspected of being caused by a medical device or IVD during the process of using or conducting post-marketing surveillance, must report the event either to the licensee, holder of the certificate of registration, the manufacturer, the authorised representative or the Council. |