Singapore legislation

Regulation 25

of Human Biomedical Research (Tissue Banking) Regulations 2019

Regulation 25

Management of tissue contamination

Subregulation 1

Every transplantational tissue bank must establish a system to prevent or control the spread of any communicable disease which is or may be due to the contamination or infection of any tissue under the supervision and control of the tissue bank.

Subregulation 2

The transplantational tissue bank must ensure that the system mentioned in paragraph (1) must at the minimum take into consideration the following in relation to the tissue under the supervision and control of the tissue bank that is or may be contaminated or infected in any other way:

(a)

the traceability of the tissue;

(b)

the traceability of the equipment and material used in the processing of the tissue;

(c)

the processing and preservation of the tissue;

(d)

the recall procedure for the tissue.

Subregulation 3

A transplantational tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —

(a)

in the case of an individual, to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both; or

(b)

in any other case, to a fine not exceeding $20,000.