Acts Online
GT Shield

National Health Act, 2003 (Act No. 61 of 2003)


Regulations relating to Human Stem Cells

Chapter 1

12. Quality and safety of stem cells


A stem cell establishment shall take necessary measures to ensure that—

(a) an updated quality system based on the principle of good practice is put in place;
(b) the quality system referred to in paragraph (a) includes at least the following documentation:
(i) standard operating procedures (SOP);
(ii) guidelines;
(iii) training and reference manuals;
(iv) reporting forms;
(v) donor records; and
(vi) information on the final destination of stem cells.
(c) the documentation referred to in paragraphs (a) and (b) is available for inspection by the inspector of anatomy or an investigating officer.