Chapter Vii Labelling

This page summarises the key rules in this chapter of the Medical Devices Rules 2017 and links to the relevant primary source.

Official source: MDR 2017 — CDSCO

Chapter VII prescribes labeling requirements for medical devices, including mandatory use of Hindi and English languages on labels and packaging. Labels must include device name, manufacturer details, batch/serial numbers, expiry dates, storage instructions, warnings, contraindications, and directions for use. Requirements vary based on device classification and intended use.