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