MAH Services
Your Official Marketing Authorization
Holder in Sri Lanka
Seamlessly enter and operate in the Sri Lankan market with a trusted, compliant, and professional local partner. We are your legal presence, ensuring your products meet all regulatory requirements.
Gateway to the Sri Lankan Market
What is a Marketing Authorization Holder (MAH) and Why Do You Need One?
To ensure the safety and quality of products available to the public, the National Medicines Regulatory Authority (NMRA) of Sri Lanka mandates that any foreign manufacturer wishing to register and sell medical devices or cosmetics must appoint a local, legally-recognized entity. This entity is known as the Marketing Authorization Holder (MAH).
The MAH is not just a name on a form; they are your official representative and are legally responsible for the product in the Sri Lankan market. They act as the primary point of contact for the NMRA and bear the responsibility for all regulatory matters, from initial registration to post-market surveillance.
Without a registered MAH, you cannot legally market your products in Sri Lanka.
Our Comprehensive MAH Services
Your End-to-End Regulatory Partner
When you appoint RAQ as your MAH, you receive a complete, end-to-end service package designed to manage your regulatory obligations efficiently and professionally. We handle every detail, so you can focus on your business growth.
Official NMRA Liaison
We act as your formal, recognized point of contact for all communications with the NMRA, ensuring that all interactions are professional, timely, and clear.
Complete Product Registration Management
We manage the entire lifecycle of your product registration, from dossier preparation and submission to responding to queries and securing final approval.
Importation and Customs Support
We handle the necessary import licenses and provide support to ensure your products clear customs smoothly and without unnecessary delays.
Post-Market Surveillance & Vigilance
We fulfill all mandatory post-market obligations, including adverse event reporting and vigilance activities, to ensure your products remain compliant and safe for consumers.
License and Renewal Management
We proactively track and manage the renewal of your product licenses and registrations, ensuring there are no lapses in your authorization to market.
Management of Variations and Amendments
Should your product or its documentation change, we manage the submission of variations and amendments to the NMRA to keep your registration current.
The RAQ Advantage
Why Appoint RAQ as Your MAH?
Choosing the right partner is critical for your success. At RAQ, we offer more than just a name; we offer a strategic advantage.
Mitigate Risk, Ensure Compliance
With our expert team managing your regulatory affairs, you significantly reduce the risk of non-compliance, costly fines, or market access delays. We ensure every requirement is met, giving you complete peace of mind.
Accelerate Your Time-to-Market
Our deep understanding of the NMRA’s processes and our meticulous approach to documentation mean a more efficient submission process. We help you get your products to market faster.
Focus on What You Do Best
Let us handle the complex regulatory burden. By entrusting your compliance to RAQ, your team can concentrate on its core activities: innovation, marketing, and growing your business in Sri Lanka.
Who We Serve
Is This Service for You?
Our Marketing Authorization Holder (MAH) service is specifically designed for:
International manufacturers of medical devices or cosmetics.
Companies that do not have a registered legal entity or physical office in Sri Lanka.
Businesses looking for a professional, reliable, and independent local partner to manage their regulatory responsibilities.
Our Simple Onboarding Process
Getting Started is Easy
While not always a mandatory requirement, implementing an ISO 9001-compliant QMS is a powerful strategic decision, especially for businesses operating in or alongside regulated industries.
Consultation & Agreement
We begin with a detailed consultation to understand your product portfolio and needs. We then execute a formal MAH agreement that clearly outlines our roles and responsibilities.
Knowledge Transfer & Dossier Preparation
You provide us with the necessary product documentation. Our team reviews it for completeness and prepares the full submission package in accordance with NMRA guidelines.
Submission & Active Management
We submit the application on your behalf and take over as the official point of contact. You receive regular updates as we manage the process through to approval and beyond.
Call to Action
Ready to Secure Your Place in the Sri Lankan Market?
Appoint RAQ as your trusted Marketing Authorization Holder and let us pave the way for your success. Contact us today to schedule your initial consultation.