Labelling Requirements

Device labelling in India must comply with Schedule 3 of the Medical Devices Rules 2017. Key requirements include English (mandatory) plus regional language options, mandatory label elements (device name, manufacturer, lot/serial number, expiry, IFU reference), and For electronic Instructions for Use (eIFU), manufacturers must obtain prior approval from CDSCO. secure digital access, offline availability of critical safety information where feasible.

Official source: Medical Devices Rules 2017, Schedule 3, Rules 55–62

Electronic Instructions for Use (eIFU) may be provided in digital format (e.g., QR codes, websites, mobile applications) as a supplement or alternative to printed instructions, subject to prior approval by CDSCO. Requirements for eIFU include: secure and reliable access mechanisms, identical content to approved printed IFU, version control and update procedures, user accessibility features, and offline availability options where feasible. Critical safety information must remain available in printed format unless otherwise approved.