Your trusted Local Authorized Representative for NMRA compliance and market entry
In the dynamic healthcare landscape of Sri Lanka, the demand for Medical Devices is on a steady rise. The National Medicines Regulatory Authority (NMRA), functioning under the Ministry of Health (MoH), is the key regulatory body overseeing this sector. For foreign companies, navigating the Sri Lankan medical device registration landscape requires a Local Authorized Representative, a role that RAQ by Healin' Pvt Ltd is adept at fulfilling.
National Medicines Regulatory Authority (NMRA)
Under the Ministry of Health (MoH)
NMRA Act, No. 5 of 2015
Labeling Requirements: Section 77
Registration + Import License
License Validity: 5 Years
ISO 13485:2016
Quality Management System for Medical Devices
English, Sinhala & Tamil
For labels and Instructions for Use (IFU)
RAQ by Healin' Pvt Ltd
Your Sri Lanka Local Authorized Representative
Medical Devices Regulatory (MDR) Division handles the assessment of technical data and ensures compliance with NMRA standards.
Paper-based submission with all required documentation in proper format and language requirements.
Referencing the NMRA's draft guidelines as of 25-08-2019, Sri Lanka employs a risk-based classification system for medical devices. RAQ by Healin' Pvt Ltd can guide you through this classification, ensuring that your products are accurately categorized.
| Device Class | Risk Level | Examples |
|---|---|---|
| Listed Device | Lowest | Toothbrush, Feeding bottle, Biosafety cabinets etc. |
| Class I | Low | Reusable Surgical instrument, Cotton wool etc. |
| Class IIa | Medium | Contact lenses, Endoscopes, Ultrasound scanners etc. |
| Class IIb | Moderate | Orthopaedic implants, Dental implants, Haemodialysis machines etc. |
| Class III | High | Cardiac pacemakers, Angiography catheters, Cranial shunts etc. |
| Class | Risk Level |
|---|---|
| Class A | Low Individual Risk and Low Public Health Risk |
| Class B | Moderate Individual Risk and/or Low Public Health Risk |
| Class C | High Individual Risk and/or Moderate Public Health Risk |
| Class D | High Individual Risk and High Public Health Risk |
Successfully navigating the registration and import process in Sri Lanka requires a series of meticulously managed steps, a process where RAQ by Healin' Pvt Ltd excels:
Before any import or registration steps, it is mandatory to register the manufacturing site with the NMRA. This foundational step ensures that the manufacturing processes meet the regulatory standards set by the Sri Lankan authority.
Following the manufacturing site registration, the next step involves obtaining a sample import license. This license allows for the importation of device samples for testing and evaluation, setting the stage for full registration.
Once the sample import license is obtained, the actual device registration process begins. This involves submitting the device along with all necessary documentation, sample labels, and Instructions for Use (IFU) in English, Sinhala, and Tamil to the NMRA for approval.
Following the NMRA's approval of the device registration, an import license for the commercial consignment of the devices is required. This final step permits the marketing and distribution of the medical devices in Sri Lanka.
Post-approval, RAQ by Healin' Pvt Ltd offers a range of services to ensure ongoing compliance and management of your medical devices. Our services include change management for existing approvals, maintenance and renewal of licenses, and continuous liaison with the NMRA. We also manage all aspects of importation, ensuring a smooth transition from regulatory approval to market presence.
Our team at RAQ by Healin' Pvt Ltd is skilled in every aspect of the Sri Lankan medical device regulatory landscape:
With RAQ by Healin' Pvt Ltd, you can navigate the complexities of the Sri Lankan healthcare market with confidence, assured by our commitment to precision, compliance, and your success.
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