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Your Source for Sri Lankan Regulatory Intelligence

Stay ahead of regulatory changes, industry trends, and best practices in the medical device and cosmetics sectors. From in-depth guides to timely updates, our insights help you navigate the path to market with confidence.

Navigating the NMRA Reliance Pathway: A Guide for Medical Device Importers

The NMRA’s new reliance pathway, effective October 2025, represents a significant opportunity for manufacturers from recognized regions to accelerate their product registration. This guide breaks down the eligibility criteria, required documentation, and strategic advantages of leveraging this new framework.

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Cosmetics vs. Medical Device vs. Borderline: How to Classify Your Product Correctly in Sri Lanka

Cosmetics vs. Medical Device vs. Borderline: How to Classify Your Product Correctly in Sri Lanka

A rejected dossier can lead to significant delays and costs. We outline the five most common pitfalls we see in submissions to the NMRA and provide expert tips to ensure your application is complete, accurate, and accepted the first time.

5 Common Mistakes in Dossier Submission and How to Avoid Them

5 Common Mistakes in Dossier Submission and How to Avoid Them

A rejected dossier can lead to significant delays and costs. We outline the five most common pitfalls we see in submissions to the NMRA and provide expert tips to ensure your application is complete, accurate, and accepted the first time.

Navigating the NMRA Reliance Pathway: A Guide for Medical Device Importers

Navigating the NMRA Reliance Pathway: A Guide for Medical Device Importers

The NMRA’s new reliance pathway, effective October 2025, represents a significant opportunity for manufacturers from recognized regions to accelerate their product registration. This guide breaks down the eligibility criteria, required documentation, and strategic advantages of leveraging this new framework.

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