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Registration Guidelines & Standards

NMRA · F-MDR-035 · Classification Guideline · Reliance Guidelines · ISO standards

NMRA Classification Guideline​

The NMRA Guideline for Classification of Medical Devices in Sri Lanka sets out the EU-derived classification rules for:

  • General devices: Listed Device / Class I / IIa / IIb / III
  • IVD devices: Class A / B / C / D

Originally published as a draft in 2019, this guideline forms the basis of device classification in Sri Lanka. Available from the NMRA website → Medical Devices Regulatory Division.

Consolidated Dossier Submission Checklist — F-MDR-035​

The F-MDR-035 Consolidated Dossier Submission Checklist is the mandatory format for all new medical device registration applications in Sri Lanka. It specifies precisely which documents are required, their format, and their organisation within the dossier.

Critical: From 2 June 2026, all MAHs must use the revised F-MDR-035 format. Applications submitted after this date using the old format will be rejected. Download the current version from: NMRA website → Application Forms tab → Medical Devices Regulatory Division → F-MDR-035

Reliance Pathway Guidelines​

Published by the NMRA in October 2025 with the introduction of the Reliance Pathway. This guideline specifies:

  • Eligible device classes (I, IIa, IIb — not III)
  • Accepted reference countries and regulatory authorities
  • Reduced dossier requirements for reliance applications
  • The requirement for identical technical specifications

Available from the NMRA website.

IVD Registration Requirements​

NMRA has published specific guidance for IVD registration requirements, covering:

  • Performance evaluation requirements by class
  • Sample requirements for certain IVD categories
  • Classification rules for IVD devices

Confirm the current IVD guidance document from the NMRA website.

International Standards Recognised by NMRA​

StandardApplication
ISO 13485:2016QMS — mandatory for all registered devices
ISO 14971:2019Risk management — mandatory for all registered devices
IEC 62304:2006/Amd1Software lifecycle processes
IEC 62366-1:2015Usability engineering
ISO 10993 seriesBiological evaluation
ISO 11135 / 11137 / 17665Sterilisation standards
IEC 60601-1Medical electrical equipment — general safety
IEC 60601-1-2Electromagnetic compatibility
Atomic Energy Authority ActRadiation-emitting devices (dual approval required)

How to Navigate NMRA Guidance​

  • All NMRA guidance documents are published at www.nmra.gov.lk
  • Navigate to: Medical Devices Regulatory Division → Guidance Documents / Application Forms
  • Always download fresh copies — guidance documents are updated periodically
  • Subscribe to NMRA circulars mailing list for announcements of updates