Registration Pathway Overview

NMRA · Two-step market entry · Consolidated Dossier · F-MDR-035

The Two-Step Market Entry — LK-Unique

Sri Lanka requires two separate regulatory approvals before a device can be commercially supplied:

Step	Approval	What It Means
1	Registration Certificate	Device assessed and found to meet NMRA safety and performance requirements
2	Import Licence	Device may be commercially imported and supplied to the Sri Lankan market

Each step requires a separate application to the NMRA. The Registration Certificate must be obtained before the Import Licence can be applied for.

Pre-Registration Prerequisites

Before submitting a Registration Certificate application:

1. Appoint a Marketing Authorization Holder (MAH)

The MAH must be a Sri Lanka-based entity. The MAH submits the application, holds all approvals, and bears full post-market regulatory responsibility.

2. Register the Manufacturing Facility with NMRA

Foreign manufacturing sites must be registered with and approved by the NMRA before any product application can be submitted. This is a standalone process involving:

• Submission of a Site Master File (SMF)
• NMRA review and possible on-site audit
• Audit waiver available for SRA-inspected sites or WHO PQ-certified sites

See Foreign Facility Registration for details.

3. Obtain Sample Import Licence (if local testing required)

For device categories requiring local testing (blood-contacting devices, latex products, feeding bottles, etc.), a Sample Import Licence must be obtained to bring in test samples before registration is complete.

Submitting the Registration Application

The MAH submits a Consolidated Dossier to the NMRA Medical Devices Regulatory Division using the F-MDR-035 checklist (revised format effective 2 June 2026).

Two registration routes are available:

Route	Basis	Best For	Class III?
Full Registration	Complete NMRA review	Devices without reference country approval	MDEC review required
Reliance Pathway	Reference country approval (from Oct 2025)	Class I/IIa/IIb with FDA/CE/TGA/etc. approval	Still requires MDEC review

MDEC Review — For High-Risk Devices

Applications for Class IIb and Class III devices are referred to the Medical Devices Evaluation Committee (MDEC) for expert technical review. MDEC provides a recommendation to the NMRA, which makes the final regulatory decision.

MDEC review adds time to the process — plan for at least 6 months for Class IIb/III devices, and longer for novel or complex technologies.

Registration Certificate

Upon approval, the NMRA issues a Registration Certificate to the MAH. The initial certificate is typically valid for 1–2 years (provisional), after which renewal is needed.

Import Licence Application

Once the Registration Certificate is issued, the MAH submits a separate Import Licence application to the NMRA, which authorises commercial importation for market supply.

Timeline Summary

Route	Class	Approximate Timeline
Reliance	I / IIa	2–4 months
Reliance	IIb	3–5 months (MDEC)
Full	I / IIa	4–6 months
Full	IIb	5–8 months (MDEC)
Full	III	6–12+ months (MDEC)