National Health Act, 2003 (Act No. 61 of 2003)RegulationsRegulations relating to Human Stem CellsChapter 110. Traceability |
A stem cell establishment must ensure that—
| (1) | all its activities referred to in regulation 2(1)(a), (b) and (c) can be traced from donor to the recipient and vice versa. |
| (2) | it has a unique donor identification system which assigns a code to each donation and to each products associated with it. |
| (3) | all stem cells are identified with a label that contains the information or references allowing a link to the information referred to in regulation 5(1)(b). |
| (4) | data necessary to ensure traceability at all stages is kept for a minimum of 30 years after donation or clinical use and such data storage may be in electronic form. |