2023-09-14T04:58:20
3.0 Labelling:
The dossier should typically contain a complete set of labeling associated with the device as per the requirements of Chapter VI of these rules. Information on labelling should include the following:—
(a) Copy of original label of the device, including accessories if any, and its packaging configuration;
45[(b) Instructions for use or electronic instructions for use (Prescriber's manual);]
(c) Product brochure; and
(d) Promotional material
Have a question? Ask here!
Required fields are marked *