Singapore legislation

Regulation 36

Conduct of simple in vitro diagnostic tests

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

(a)

using testing material, where —

(i)

the earlier of the following dates has not passed:

(A)

the expiry date of the testing material;

(B)

the shelf life of the testing material; 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.