16. General provisions as to labelling

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.

All information on the label of a medical device shall be provided in English, and may, in addition, be provided in any other language.

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.

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.

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.

All information on the label of a medical device shall be provided in English, and may, in addition, be provided in any other language.

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.

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.