NMRA product registration, ISO certification, and Independent License Holder services for cosmetics, medical devices, and borderline products.
Your regulatory pathway depends on your situation. Choose your path to see the services that apply to you.
You have a registered Sri Lankan entity and import foreign cosmetics or medical devices for distribution here.
You manufacture cosmetics or medical devices in Sri Lanka and need certification plus NMRA product registration.
You want to sell in Sri Lanka but don't have a local entity. RAQ becomes your Independent License Holder and handles every regulatory obligation locally.
Choose your path - services filter to match your situation.
Full NMRA registration for imported cosmetic products - skincare, haircare, makeup and fragrances.
NMRA registration for all classes of imported medical devices - diagnostics, surgical instruments, implants and equipment.
Products with combined characteristics of medicines, cosmetics, foods or medical devices. These are among the most complex to register. We handle the critical NMRA classification and full registration under the correct pathway.
Full NMRA registration for cosmetics manufactured in Sri Lanka - skincare, haircare, makeup and fragrances.
NMRA registration for medical devices manufactured in Sri Lanka - diagnostics, surgical instruments and equipment.
Locally manufactured products with combined characteristics of medicines, cosmetics, foods or medical devices. We handle the critical NMRA classification and full registration under the correct pathway.
Cosmetics GMP certification - mandatory for all local cosmetic manufacturers before NMRA product registration can begin.
Quality management system certification for any organisation - demonstrates commitment to consistent quality and continuous improvement.
Good Manufacturing Practice certification required for local device manufacturers before NMRA product registration.
For foreign manufacturers without a Sri Lankan entity. RAQ acts as your Marketing Authorization Holder, handling full NMRA registration and import licensing under RAQ's name on your behalf.
For foreign manufacturers without a local entity
Sri Lanka's NMRA requires every imported cosmetic and medical device to have a locally licensed Marketing Authorization Holder. Without one, your products cannot legally enter the market.
RAQ Consultation acts as your Independent License Holder - fully separate from your distributors - so you retain control of your brand while we handle every regulatory obligation locally. All registrations and import licences are issued in RAQ's name on your behalf.
A structured four-stage process for every engagement.
Submit the form. We respond with a tailored proposal and price within 24 hours.
We assess your product, classify under NMRA pathways, and issue a documentation roadmap.
You upload via the secure client portal. We prepare the full NMRA dossier with safety, ingredients, labels and declarations.
We submit, handle queries from NMRA, and deliver your certificate. You track every milestone in the portal.
Search the official NMRA register for cosmetics, medical devices, and borderline products. Free, no login. Mirrored from publicly published NMRA data and refreshed weekly.
Total 10,923 records. RAQ does not modify or certify NMRA data; we mirror it for your convenience.
Four premium tools that catch compliance issues early — so your NMRA filing doesn't get bounced. Two are free forever.
10 questions. Get your NMRA readiness score with a gap list in 3 minutes.
Take quizAI-powered full formulation audit against NMRA + EU + ASEAN rules.
Start checkOnce you engage RAQ, you get a private portal account. Track every milestone, upload documents securely, settle invoices, and message us directly. No emails lost in inboxes.
Watch your dossier move through every NMRA stage with timestamps.
Token-based uploads, version history, and review status per file.
View invoices, pay online via PayHere, download receipts.
Chat with your RAQ consultant inside the portal. Nothing lost in email threads.
Automatic alerts at 60, 30, and 7 days before any certificate expires.
Score-based health view of your account, documents, and submissions.
What manufacturers and importers get when they engage us.
Based in Colombo with direct NMRA liaison.
EU MDR/IVDR aligned, NMRA-compliant
Fluent English documentation, regular progress updates
Overlap with Asia, EU, and Middle East hours
Straight answers about NMRA registration in Sri Lanka.
Cosmetics typically take 3 to 6 months from submission. Medical devices and borderline products usually take 8 to 12 months depending on classification and the queries raised by NMRA. We submit complete dossiers to minimise back-and-forth.
Every engagement is quoted individually because scope depends on product type, manufacturer documentation, and classification complexity. Submit an inquiry and we send a written proposal within 24 hours with a fixed scope and binding price.
NMRA's own statutory fees are charged separately at the rates published on nmra.gov.lk and remitted on your behalf at actuals.
Yes, through our Independent License Holder service. NMRA requires a locally licensed Marketing Authorization Holder for every imported product. RAQ acts as that MAH on your behalf, separate from your distributors, so you keep brand control while we handle every regulatory obligation locally.
Typical requirements include: Certificate of Free Sale or equivalent from your country, Good Manufacturing Practice certificate, full ingredient/composition list, finished product specifications, label artwork, safety data, and authorisation letters. Once we review your situation, you receive an exact checklist tailored to your product type and pathway.
Borderline products require a formal NMRA classification before registration can begin. We analyse intended use, mode of action, therapeutic claims, and active substances, then submit for NMRA classification under the correct schedule (I, IIA, IIB). Once classified, the registration follows the appropriate pathway.
Most rejections are query letters asking for clarifications or additional documents, not outright denials. We handle the queries directly with NMRA and resubmit at no additional consultancy fee within the original engagement. Outright denials are rare when the dossier is properly prepared upfront, which is why our review stage exists.
For locally manufactured cosmetics, NMRA mandates ISO 22716:2007 (Cosmetics GMP) before product registration. For locally manufactured medical devices, NMRA GMP is mandatory. Imported products do not need a Sri Lankan ISO; the manufacturer's home-country certifications usually suffice. We help local manufacturers achieve these certifications through structured gap analyses, documentation, and certification body liaison.
A distributor's interest is selling your product. A registration consultant's interest is regulatory compliance. RAQ stays independent of your distribution: registrations are held in RAQ's name as your MAH, so if you change distributors, your product stays registered. Your distributors compete on commercial terms, not regulatory leverage.
You receive a private client portal account with live status of every registration step, secure document upload, invoice and payment management, direct messaging with your consultant, and automatic reminders for renewals. Nothing is buried in email.
The data is sourced from publicly published NMRA registers (Excel exports and Schedule PDFs) and refreshed periodically. RAQ does not modify, certify, or warrant the entries beyond what NMRA publishes. For the authoritative status of any registration, consult nmra.gov.lk directly. The registry is provided as a convenience search tool, not a regulatory record.
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