Singapore legislation
Regulation 16
Regulation 16
General provisions as to labelling
Subregulation 1
The Authority may stipulate —
under section 24(5) of the Act, in the conditions attached to a licence in respect of a medical device; or
under section 32 of the Act, in the conditions attached to the registration of a medical device,a requirement to use a label, sticker or packaging insert or any other means for presenting any information accompanying the medical device.
Subregulation 2
All information on the label of a medical device shall be provided in English, and may, in addition, be provided in any other language.
Subregulation 3
All numbers, letters and symbols used to provide any information on the label of a medical device shall be legible, permanent and prominent in colour, size and positioning.
Subregulation 4
If a symbol or code (whether in the form of a colour or otherwise) is used to provide any information on the label of a medical device, an explanation of the symbol or code shall be provided.