Singapore legislation

Regulation 50

of Healthcare Services (Assisted Reproduction Service) Regulations 2023

Regulation 50

Conduct of simple in vitro diagnostic test

Subregulation 1

A licensee must ensure that any simple in vitro diagnostic test on a specimen or patient must be conducted —

(a)

using testing material, where —

(i)

the expiry date of the testing material has not passed; and

(ii)

the personnel who is administering the test does not suspect or have any reason to suspect that the testing material is no longer fit for use; and

(b)

in accordance with the instructions specified by the manufacturer of the testing material.

Subregulation 2

A licensee must ensure that any testing material that may be used to conduct any simple in vitro diagnostic testing is stored under the conditions, and handled in the manner, specified by the manufacturer of the testing material so as to lower the risk of unnecessary exposure of the testing material to the environment and early deterioration of the testing material.

Subregulation 3

In paragraph (1), “expiry date” has the meaning given by regulation 2 of the General Regulations.