Regulatory information
Regulatory Insights
An amended checklist, a new notice or a change in manufacturing requirements can affect a project already under way. Here we explain selected developments and provide direct links to the NMRA publications behind them.
Check the official source
The links below lead to the National Medicines Regulatory Authority's (NMRA) own information. They are not RAQ publications or product-specific advice.
- NMRA announcements
News, notices and procedural updates issued by the National Medicines Regulatory Authority.
- Revised medical-device consolidated dossier checklist
NMRA has required the revised F-MDR-035 checklist for consolidated new medical-device submissions from 7 July 2026.
- Cosmetic manufacturing-site ISO 22716 notice
NMRA explains the manufacturing-site acknowledgement and ISO 22716 certification approach for cosmetic factories in Sri Lanka.
- Local borderline-products submission notice
NMRA explains the combined submission of classification and formulation-approval documents for new local borderline-product applications.
More official references by product category: Regulatory Resources.
Practical explanations of current requirements
RAQ article · Medical devices
Medical device dossiers: using the revised NMRA checklist
A practical introduction to consolidated submissions, the current document checklist and the importance of selecting the correct route.
RAQ article · Cosmetics
Local cosmetic manufacturing: site requirements before product registration
Why cosmetic manufacturers need to address manufacturing-site acknowledgement and ISO 22716 certification before filing products.
RAQ article · Borderline products
Local borderline products: what the combined submission notice changes
What local applicants submit together, which applications continue under the older process and why classification is still a separate regulatory decision.
These articles explain general requirements and are not official NMRA instructions or advice on an individual product. Where a summary differs from a current regulation, notice or guideline, the official requirement applies.
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