Schedule 3 Labelling

This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.

Official source: MDR 2017 — CDSCO

Schedule 3 of the Medical Devices Rules 2017 specifies comprehensive labelling and instructions for use (IFU) requirements. Key requirements include: mandatory use of English language with optional regional language translations, device name and manufacturer identification, lot and serial number marking, expiry dating, sterilization method (if applicable), storage conditions, and clear IFU reference. All labels must be legible, indelible, and placed prominently on the device and packaging.