Medical Devices
Medical Device Registration in Sri Lanka
Expert navigation through the NMRA’s regulatory framework for General Medical Devices and In-Vitro Diagnostics (IVDs).
A Regulated and Secure Market
Meeting Sri Lanka’s Standard of Care
In Sri Lanka, all medical devices must be registered with the National Medicines Regulatory Authority (NMRA) to ensure they meet stringent standards for safety, quality, and performance. As defined in the NMRA Act, a “medical device” is:
“any instrument, apparatus, appliance, software, material or any other article, whether used single or in combination, including the software necessary for its proper application intended by the manufacturer used in or on human beings for the purpose of: “
- Diagnosis, prevention, monitoring, treatment or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap; - Investigation, replacement or modification of the anatomy or of a physiological
process; - Control of conception;
The NMRA classifies devices based on risk level, following the internationally recognized EU regulatory framework for medical devices and IVDs. Successfully navigating this process is critical for market access, and at RAQ, we specialize in managing these complexities to ensure your products achieve compliance efficiently and correctly.
The NMRA Reliance Pathway
Leverage Prior Approvals with the Reliance Pathway
As of October 2025, the NMRA has introduced a Reliance Pathway for faster registration of devices that have already been approved by other stringent regulatory authorities. If your device is registered in one of the following regions, you may be eligible for an accelerated review process.
Recognized Countries for General Medical Devices:
USA, UK, Australia, Canada, Japan, Norway, Switzerland, and all EU Member States.
Recognized Countries for IVD Medical Devices:
USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore, and all EU Member States.
RAQ can help you determine if your product qualifies for this pathway and prepare the specific dossier to leverage this significant advantage.
End-to-End Registration Services
A Comprehensive Solution for Device Registration
We manage the entire registration lifecycle, from initial classification to final approval, ensuring your submission is robust and fully compliant.
EU Classification & Grouping Strategy
We help you correctly classify your device according to the EU risk-based system (Class I, IIa, IIb, III for devices; List A, B, Self-test for IVDs) and develop an optimal grouping strategy for your application.
Consolidated Dossier Preparation
We compile the complete Consolidated Dossier, which combines the Foreign Manufacturing Site Application (FMSA) and the Product Registration Dossier (PRD) into a single, streamlined submission.
Technical Document Review
Our team meticulously reviews all technical documentation, including the Summary Technical Documentation (STED), clinical data, performance evaluations, and labeling to ensure they meet NMRA standards.
Professional NMRA Liaison
We act as your professional point of contact with the NMRA’s Medical Device Regulatory Division (MDRD), managing the submission and handling all regulatory queries to ensure a smooth review.
Key Requirements
Building a Compliant Dossier
A successful registration depends on a complete and accurate Consolidated Dossier. We ensure your submission includes all critical administrative and technical documents.
Key Administrative Documents
- Letter of Authorization (LOA):A formal letter from the legal manufacturer appointing you as their local agent.
- Free Sale Certificate (FSC): A valid FSC from the country of origin. We verify its compliance before submission.
- Declarations: Formal letters from the local agent confirming the dossier type and willingness to provide samples if requested.
For Local Manufacturers
- Device Description & Intended Use: Clear and concise details about the device.
- Labeling & Instructions for Use (IFU): All packaging, labels, and user manuals.
- Evidence of Conformity: Proof that the device meets quality standards (e.g., Declaration of Conformity, ISO 13485 certificate).
- Summary Technical Documentation (STED): A comprehensive summary of all technical data related to the device.
- Risk Analysis & Clinical/Performance Data: (SDS/MSDS)Documents demonstrating the device's safety and efficacy.
The RAQ Advantage
Why Partner with RAQ for Medical Device Registration?
Up-to-Date Expertise
We are fully versed in the latest NMRA updates, including the new Reliance Pathway and Consolidated Dossier requirements, ensuring your submission strategy is modern and efficient.
Strategic & Meticulous
We don’t just compile documents; we build a strategic submission. From device classification to dossier preparation, our attention to detail prevents delays and deficiencies.
Focus on Your Core Business
The regulatory landscape is complex. Let us manage the entire process, allowing you to focus your resources on innovation, manufacturing, and market strategy.
Call to Action
Bring Your Medical Technology to the Sri Lankan Market
Partner with the experts in medical device registration. Contact us today for a detailed consultation on your product.