Singapore legislation

Regulation 8A

of Human Biomedical Research Regulations 2017

Regulation 8A

Definition of “serious adverse event”

The untoward medical occurrences which result in any of the following are prescribed events for the purposes of paragraph (a)(vi) of the definition of “serious adverse event” in section 2 of the Act:

(a)

the transmission of a communicable disease;

(b)

any misidentification or mix‑up of any type of human biological material, gamete or embryo.