Singapore legislation

Regulation 18

of Health Products (Oral Dental Gums) Regulations 2016

Regulation 18

Duty to report defects and adverse effects

For the purposes of section 42(1) of the Act, every manufacturer, importer, supplier or registrant of an oral dental gum must, within 7 days after becoming aware of —

(a)

any defect in the oral dental gum; or

(b)

any adverse effect that has arisen or can arise from the use of the oral dental gum, report the defect or adverse effect (as the case may be) to the Authority.