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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 should confirm language requirements with CDSCO based on their intended distribution territory.