Sri Lanka Product Registration & Certification
Important Notes
- NMRA Registration: All pharmaceuticals, medical devices, and "medicinal cosmetics" must be registered with the National Medicines Regulatory Authority to obtain import and marketing licenses.
- Local Registration Holder (Agent): Foreign manufacturers must appoint a locally registered company in Sri Lanka as the registration holder (local agent/importer) to submit applications and assume regulatory responsibility.
- Technical Documentation & WHO Prequalification: Registration documents must be in English. NMRA recognizes WHO Prequalification (PQ) for medicines and Prequalification of Diagnostics (PQS), which can streamline the process.
- Labeling & Language Requirements: Product labels and instructions must be trilingual: English, Sinhala, and Tamil. Key information (name, strength, expiry) must be clear in all three languages.
- Price Control & Registration: All registered products require price approval and registration with NMRA. Prices are referenced to International Reference Pricing (IRP) and must align with government affordability policies.
- Quality Control & Sample Testing: Registration typically requires sample submission to NMRA-designated labs for testing or providing a Certificate of Analysis from an internationally accredited lab.
Sri Lanka Specific Requirements
- Public Procurement-Dominated Mixed Market: The free state healthcare system makes government tenders (especially MOH) the main market driver, but the private hospital and pharmacy segment is growing rapidly among higher-income groups.
- High Reliance on International Agency Certification: With limited resources, NMRA heavily relies on WHO prequalification and approvals from Stringent Regulatory Authorities (e.g., FDA, EMA) as key inputs for its registration reviews.
- Price Sensitivity & Affordability Priority: As a lower-middle-income country, strict government price control makes price competitiveness a crucial factor for winning public tenders.
- Parallel System of Traditional Medicine (Ayurveda): Alongside modern medicines, Ayurvedic products are governed by separate regulations and enjoy a broad market base and cultural acceptance.
- Market Potential as a SAARC Member: Under regional trade agreements, there is potential to access neighboring South Asian markets, though logistics and distribution networks need strengthening.
Medical Devices Registration
Regulatory Requirements
- Medical Device Import Registration Certificate
- Classification according to NMRA risk categories (Class A, B, C, D)
- Technical documentation and test reports
- Quality Management System certificate (ISO 13485)
- Trilingual labeling requirements (English/Sinhala/Tamil)
- Free Sale Certificate and Certificate of Origin
Main Process
- Product classification determination
- Technical documentation preparation
- Local representative designation
- NMRA registration application
- Product testing completion
Registration Timeline
9-24 months
Official Fees
LKR 200,000 - 5,000,000
Service Fees
$15,000 - $50,000
Regulatory System Overview
NMRA
National Medicines Regulatory Authority
Responsible for medical devices, pharmaceuticals, and health products registration, quality supervision, and market surveillance, operating under Ministry of Health
CAA
Consumer Affairs Authority
Responsible for cosmetics and consumer goods market regulation, price control, and consumer rights protection
MOH
Ministry of Health
Responsible for national health policies, regulatory frameworks, and public health programs, supervising NMRA operations
Medical Devices Registration Process
Product Classification
Determine product risk classification according to NMRA medical device classification rules (Class A/B/C/D)
Technical Documentation
Prepare complete technical documentation including specifications, test reports, clinical data
Local Authorized Representative
Designate authorized representative in Sri Lanka (mandatory requirement)
NMRA Registration
Submit medical device registration application and supporting documents to NMRA
Product Testing
Complete necessary product performance and safety testing at NMRA-approved laboratories
Cosmetics Registration
Regulatory Requirements
- Cosmetic Import License
- Ingredient safety assessment report
- Trilingual labeling compliance (English/Sinhala/Tamil)
- Good Manufacturing Practice certificate
- Compliance with Sri Lanka cosmetic standards
Main Process
- Ingredient compliance assessment
- Safety assessment completion
- Import license application
- Labeling review confirmation
- Market access approval
Registration Timeline
6-12 months
Official Fees
LKR 100,000 - 1,000,000
Service Fees
$8,000 - $20,000
Regulatory System Overview
NMRA
National Medicines Regulatory Authority
Responsible for medical devices, pharmaceuticals, and health products registration, quality supervision, and market surveillance, operating under Ministry of Health
CAA
Consumer Affairs Authority
Responsible for cosmetics and consumer goods market regulation, price control, and consumer rights protection
MOH
Ministry of Health
Responsible for national health policies, regulatory frameworks, and public health programs, supervising NMRA operations
Cosmetics Registration Process
Ingredient Compliance
Confirm all ingredients comply with Sri Lanka cosmetic standards and prohibited substances list
Safety Assessment
Prepare product safety assessment report by qualified safety assessor
Import License Application
Submit cosmetic import license application to Consumer Affairs Authority (CAA)
Trilingual Labeling
Ensure labeling contains required information in English, Sinhala, and Tamil
Local Agent Designation
Designate authorized agent or distributor in Sri Lanka
Health Supplements Registration
Regulatory Requirements
- Health Product Registration Certificate
- Ingredient safety and quality evidence
- Trilingual labeling requirements
- Good Manufacturing Practice certificate
- Scientific basis for health claims
Main Process
- Product classification determination
- Technical documentation preparation
- Registration application submission
- Labeling compliance confirmation
- Regulatory approval acquisition
Registration Timeline
8-18 months
Official Fees
LKR 150,000 - 2,000,000
Service Fees
$10,000 - $30,000
Regulatory System Overview
NMRA
National Medicines Regulatory Authority
Responsible for medical devices, pharmaceuticals, and health products registration, quality supervision, and market surveillance, operating under Ministry of Health
CAA
Consumer Affairs Authority
Responsible for cosmetics and consumer goods market regulation, price control, and consumer rights protection
MOH
Ministry of Health
Responsible for national health policies, regulatory frameworks, and public health programs, supervising NMRA operations
Health Supplements Registration Process
Product Classification
Determine product category: Food, Health Supplement, Traditional Medicine or Pharmaceutical
Technical Documentation
Prepare complete documentation including ingredient analysis, safety evidence, stability studies
NMRA Registration
Submit health supplement registration application and technical data to NMRA
Trilingual Labeling
Ensure labeling complies with trilingual requirements and contains all mandatory information
Local Testing
Complete necessary product quality and safety testing at Sri Lanka approved laboratories