DONATED HUMAN TISSUE: IS IT A MEDICAL DEVICE OR JUST TISSUE?

Abstract

Donated human tissue can be used in various ways. Bone and skin received by an authorised Tissue Bank are preserved and processed in order to be used in transplantations later. The question arises whether these products derived from human tissue stays just human tissue or do they become medical devices. The importance of this distinction is mainly to determine which legislative framework applies. Neither the National Health Act nor the Medicines and Related Substances Act give guidance on how to classify products as medical devices or human tissue. A Draft Guidance from the United States of America is analysed as well as a Directive from the European Communities. It is recommended that South Africa should change its current laws to give clarity to Tissue Banks.