Product Registration
Your Clear Path to Product Registration in Sri Lanka
We provide expert, end-to-end management of the NMRA registration process, ensuring your products meet all regulatory requirements for a successful market launch.
The Foundation of Market Access
Why Product Registration is a Critical First Step
Before any medical device or cosmetic can be legally imported, manufactured, or sold in Sri Lanka, it must be registered with the National Medicines Regulatory Authority (NMRA). This mandatory process is the cornerstone of public health and safety, ensuring that all products available in the market are effective, safe, and of high quality.
Navigating this process requires a deep understanding of the specific requirements for different product types, meticulous documentation, and professional communication with the regulatory authorities. At RAQ, we specialize in managing this entire journey on your behalf, transforming a complex requirement into a clear and predictable process.
Our Registration Services
Specialized Expertise for Your Product Category
We understand that one size does not fit all. Our team possesses specialized expertise in the unique registration pathways for different product categories.
Medical Devices
From low-risk to high-risk devices (classified as per EU regulations), we manage the entire submission process to the NMRA, including technical dossier compilation and classification support.
Cosmetics
We ensure your cosmetic products meet all NMRA requirements, from ingredient review and labeling to Free Sale Certificate (FSC) validation.
Borderline Products
For products that blur the lines between categories, we provide expert guidance to achieve a clear classification from the NMRA and navigate the correct registration pathway, avoiding costly delays.
Our Proven Registration Process
A Streamlined Journey to Approval
Our structured process is designed for efficiency, transparency, and success.
Strategy & Dossier Review
We begin by classifying your product and developing a clear registration strategy. Our team then meticulously reviews your existing documentation and identifies any gaps.
Dossier Compilation & Submission
We compile a complete, compliant, and professional submission package in the precise format required by the NMRA. Once finalized, we submit the dossier on your behalf.
Regulatory Liaison & Follow-Up
Upon receiving approval, we ensure you have the final marketing authorization. We also provide ongoing support for renewals and post-market compliance to maintain your registration.
Approval & Post-Market Support
We act as your primary point of contact with the NMRA, professionally managing all queries and communications to ensure the review process keeps moving forward.
RAQ Advantage
Why Partner with RAQ for Your Product Registration?
Deep NMRA Expertise
Our team has an in-depth, practical understanding of the NMRA’s procedures and requirements. This expertise minimizes errors and accelerates the review process.
Meticulous Attention to Detail
We believe in getting it right the first time. Our rigorous internal review process ensures your submission dossier is complete and accurate, reducing the likelihood of queries and delays.
Save Time and Resources
Let our team manage the complexities of the registration process, freeing up your internal resources to focus on what they do best growing your business.
Call to Action
Ready to Bring Your Product to the Sri Lankan Market?
Let us handle the complexities of registration so you can launch with confidence. Contact us today for a consultation on your product.