Sri Lanka Medical Device Labeling: NMRA Requirements and Trilingual IFU for Patients

Sri Lanka Medical Device Labeling: NMRA Requirements and Trilingual IFU for Patients

All medical devices placed on the market in Sri Lanka must adhere to the labeling requirements set forth by the National Medicines Regulatory Authority (NMRA). The NMRA mandates the use of both primary and secondary labels, which must be submitted for review as part of the initial product registration dossier.

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Mandatory Labeling Content

The primary and secondary labels are required to contain detailed, compliant information to ensure safety and traceability. The original label submitted during registration must include:

1. Product Identification: The product’s approved name and brand name (if applicable).
2. Manufacturer Information: The name and address of the actual manufacturer.
3. Sterility: An indication of whether the product is sterile, along with the mode of sterilization used.
4. Storage: Specific storage conditions, including temperature requirements.
5. Traceability and Dates:
   • The manufacturing date and expiry date (where applicable).
   • The lot or batch number.
6. Patient Information Leaflet (PIL): All products must be accompanied by a patient information leaflet or Instructions for Use (IFU).

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Trilingual Requirement for Patient-Handled Devices

A unique and critical requirement in Sri Lanka focuses on accessibility for devices intended for direct patient use:

• Devices Affected: Products intended to be handled directly by patients in the household setting (e.g., glucometers, hearing aids, spacer devices, nebulizers, etc.).
• Language Requirement: The associated patient information leaflet (PIL) must be provided in all three official languages of Sri Lanka:
  • English
  • Sinhala
  • Tamil

This trilingual requirement ensures that essential safety and usage instructions are accessible to the diverse user population across Sri Lanka, a key regulatory focus of the NMRA.

The local Marketing Authorization Holder (MAH) is responsible for ensuring the ongoing compliance of all primary and secondary labels with these NMRA requirements throughout the product's life cycle.