Singapore legislation
Regulation 19A
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 19A
Duty to report defects
Amended byS 108/2021 wef 01/03/2021
For the purposes of section 42(1)(a) of the Act, every manufacturer, importer or supplier of any clinical research material must report any defect in the clinical research material to the Authority within the following period after the manufacturer, importer or supplier (as the case may be) first becomes aware of the defect:
(a)
if the defect represents a serious threat to persons or public health, within 48 hours;
(b)
in all other cases, within 15 days.