Intellectual Property Rights from Publicly Financed Research and
R 385
Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsRegulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs)26. Record of implantable medical device and custom made medical device |
| (1) | A permanent record in respect of a Class D implantable medical device and a high-risk custom made medical device must be kept on the premises by the healthcare institution or healthcare professional where the medical devices are sold to the patient, and must contain the following information: |
| (a) | The name and the product code of the medical device; |
| (b) | the date on which the order for the implantable or custom made medical device was raised; |
| (c) | the model number, batch number, and serial number, if applicable; |
| (d) | the name, address and identity number of the patient; |
| (e) | where applicable, the name of the user and, in the case of an implantable medical device, the person responsible for the implantation of the medical device; |
| (f) | the name and address of the health establishment; |
| (g) | the name of the manufacturer of the implantable or custom made medical device; and |
| (h) | information relating to the design, manufacturing and performance of the medical device including expected performance. |
| (2) | The order record must be retained at the business address of the seller for a period of at least five years beyond the expected life of the medical device. |
| (3) | The manufacturer, distributor or wholesaler of Class D or implantable custom made medical devices must keep a record of Class D or implantable custom made medical devices in the form of invoices that must reflect— |
| (a) | the date of transaction of every sale; |
| (b) | the proprietary name of the medical device; |
| (c) | the name and address of every purchaser; |
| (d) | the quantities sold; and |
| (e) | the batch number or serial number. |
| (4) | A record referred to in subregulation (3) must be kept for a period of fifty years from the date of sale. |
