Singapore legislation
Regulation 22
of Healthcare Services (Human Tissue Banking Service) Regulations 2023
Regulation 22
Restrictions on distribution of human tissue
Subregulation 1
A licensee must not distribute any human tissue except with the approval of a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer.
Subregulation 2
A licensee must not distribute any human tissue to a person unless —
the person is another licensee that is approved to provide a human tissue banking service for that type of human tissue;
the person is licensed under the Act to provide a licensable healthcare service for the purpose of treating a condition treatable by the transplant of that type of human tissue; or
where the person is established or incorporated outside Singapore — the person is licensed, registered, approved or otherwise regulated to carry on the activities of a human tissue bank or healthcare institution under the laws of the jurisdiction in which the person is established or incorporated.
Subregulation 3
A licensee must not distribute any human tissue for a purpose in respect of which the donor or authorised person (as the case may be) has not given written consent.
Subregulation 4
Where any human tissue is determined to be unsuitable for transplant or other clinical use, a licensee must ensure that the human tissue is distributed in accordance with the requirements of these Regulations and for a purpose for which the donor or authorised person (as the case may be) has given written consent.