Which Products are considered Regulated Products?

According to section 7A(1) of the Human Organ Transplant Ordinance (Cap. 465) ("the Ordinance"), a regulated product means a product containing any structured arrangement of tissues that-

1. falls within paragraph (a)(iii) of the definition of "organ" in section 2 of the Ordinance:

   "Organ" means any structured arrangement of tissues forming part of any human bodily part which consists of a structured arrangement of tissues; and if wholly removed, cannot be regenerated by the body; or any structured arrangement of tissues forming part of any human bodily part specified in the Schedule of the Ordinance, that is blood (including cord blood) and bone marrow; and

2. has been subjected to processing:

   "Processing", in relation to any structured arrangement of tissues, means any activity performed on the tissues that alters the biological characteristics, function or integrity of the tissues, but does not include recovering or preparing the tissues, preserving the tissues for storage, or removing the tissues from storage.

The scope of regulated products does not include autologous therapeutic products. In addition, tissue products that are unprocessed or only subjected to preparation or preservation steps are excluded.

Examples of regulated products include skin and bone derived products. The regulated products are to be used for transplant purposes only.