Singapore legislation
Regulation 36
of Healthcare Services (Human Tissue Banking Service) Regulations 2023
Regulation 36
Outsourcing
Subregulation 1
Subject to this regulation, a licensee must not appoint any person to provide, on the licensee’s behalf, a human tissue banking service or any aspect of the human tissue banking service.
Subregulation 2
A licensee may appoint any of the following persons to conduct, on the licensee’s behalf, any test of any collected human tissue that the licensee considers necessary to ensure the safety and quality, and, where applicable, the viability and potency, of the human tissue:
another licensee that is approved to provide a human tissue banking service for the same type of human tissue;
a person who is authorised by a licence to provide a clinical laboratory service;
a person who operates a human tissue bank for the same type of human tissue or a clinical laboratory outside Singapore that is accredited by an accreditation body acceptable to the Director‑General.
Subregulation 3
Where a licensee has appointed a person under paragraph (2) to conduct any test of any human tissue, the licensee must retain a copy of the test report provided by that person.
Subregulation 4
A licensee may, for or in relation to the implementation of a contingency plan mentioned in regulation 33, appoint any person to process, store or distribute any human tissue on the licensee’s behalf.
Subregulation 5
To avoid doubt, a licensee that appoints another person to carry out any activity under paragraph (2) or (4) remains responsible to comply with the licence conditions imposed on and the duties of a licensee under the Act, these Regulations and any other regulations made under the Act.