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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 promotional claims controls under the D&C Act.

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

Mandatory Schedule 3 Label Elements

Every device label must clearly display:

  1. Device name (as per approved product dossier)
  2. Manufacturer's name and address
  3. Lot number or batch number
  4. Serial number (if applicable)
  5. Date of manufacture
  6. Date of expiry or shelf-life
  7. Reference to Instructions for Use (IFU)
  8. Storage conditions (temperature, humidity, light sensitivity)
  9. Sterility statement (if applicable)
  10. Caution statements and symbols as required
  11. Device classification or intended use
  12. CE mark (if applicable for exports)

All elements must be legible, indelible, and placed where they are easily visible. Font size and contrast must meet readability standards for the intended user population.