Labelling Requirements

Device labeling in India must comply with Schedule 3 of the Medical Devices Rules 2017. English is mandatory; regional language labeling should be provided based on distribution territory. Mandatory label elements include device name, manufacturer and address, lot/serial number, date of manufacture, expiry/shelf-life, storage conditions, reference to Instructions for Use (IFU), and applicable caution statements. All claims must comply with the Drugs and Cosmetics (D&C) Act and Rules.

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

Regional Language Requirements

While English labeling is mandatory, regional language labeling may be required based on the state of distribution:

• Devices distributed in states where a specific regional language is predominant should include labeling in that language
• Common regional languages include Hindi, Tamil, Telugu, Marathi, Gujarati, Kannada, Malayalam, and others
• The language used must be clear, accurate, and complete—not merely a translation
• Regional language labeling is particularly important for patient-facing information and Instructions for Use (IFU)

Manufacturers must confirm language requirements with CDSCO based on their intended distribution territory before finalizing labeling. This is particularly critical for devices with regional distribution; confirmation should be sought in writing and retained as part of the regulatory file.

Exemptions: Regional language labeling may not be required for devices with minimal patient contact (e.g., certain in vitro diagnostics or hospital-use-only devices) if approved by CDSCO. Manufacturers should seek written confirmation from CDSCO regarding exemptions before finalizing labeling.