Accepting New Clients

Register Your Products in Sri Lanka

From local importers to global brands - full NMRA compliance, end-to-end.

No commitment - receive a personalised consultation within 24 hours
Who We Serve

Which Best Describes You?

Your regulatory pathway depends on your situation. Choose your path to see the services that apply to you.

🇱🇰

I'm a Local Importer

You have a registered Sri Lankan entity and import foreign cosmetics or medical devices for distribution here.

  • Cosmetic Registration - Import
  • Medical Device Registration - Import
  • Borderline product classification
  • Sample import licence
See Import Services
🏭

I'm a Local Manufacturer

You manufacture cosmetics or medical devices in Sri Lanka and need certification plus NMRA product registration.

  • ISO 22716:2007 (mandatory for cosmetics)
  • NMRA GMP (medical devices)
  • Cosmetic / Device Registration - Local
  • Borderline product classification
See Manufacturing Services
Services

What We Offer

Choose your path - services filter to match your situation.

Cosmetic Registration - Import

Full NMRA registration for imported cosmetic products - skincare, haircare, makeup and fragrances.

  • Complete dossier preparation
  • CosIng ingredient verification
  • Safety assessment reports
  • NMRA submission & follow-up
3-6 months Free consultation

Medical Device Registration - Import

NMRA registration for all classes of imported medical devices - diagnostics, surgical instruments, implants and equipment.

  • Device classification guidance
  • Technical documentation review
  • Clinical evaluation support
  • Post-market surveillance setup
4-8 months Free consultation

Borderline Products - Import

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.

  • Intended use & mode of action analysis
  • Therapeutic claims review
  • Active substance & formulation assessment
  • NMRA classification & pathway determination
4-8 months Free consultation

Cosmetic Registration - Local Manufacture

Full NMRA registration for cosmetics manufactured in Sri Lanka - skincare, haircare, makeup and fragrances.

  • Complete dossier preparation
  • CosIng ingredient verification
  • Safety assessment reports
  • NMRA submission & follow-up
Requires ISO 22716:2007 certification first
3-6 months Free consultation

Medical Device Registration - Local Manufacture

NMRA registration for medical devices manufactured in Sri Lanka - diagnostics, surgical instruments and equipment.

  • Device classification guidance
  • Technical documentation review
  • Clinical evaluation support
  • Post-market surveillance setup
Requires NMRA GMP certification first
4-8 months Free consultation

Borderline Products - Local Manufacture

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.

  • Intended use & mode of action analysis
  • Therapeutic claims review
  • Active substance & formulation assessment
  • NMRA classification & pathway determination
GMP requirement depends on classification
4-8 months Free consultation

ISO 22716:2007

Cosmetics GMP certification - mandatory for all local cosmetic manufacturers before NMRA product registration can begin.

  • Gap analysis & readiness audit
  • Documentation development
  • Staff training programs
  • Certification body liaison
Tailored timeline Free consultation

ISO 9001:2015

Quality management system certification for any organisation - demonstrates commitment to consistent quality and continuous improvement.

  • QMS gap analysis
  • Process documentation
  • Internal audit training
  • Certification body liaison
Tailored timeline Free consultation

NMRA GMP (Medical Devices)

Good Manufacturing Practice certification required for local device manufacturers before NMRA product registration.

  • Facility assessment
  • GMP documentation
  • Staff training programs
  • NMRA inspection prep
Tailored timeline Free consultation

MAH / Independent License Holder

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.

  • NMRA product registration in RAQ's name
  • Import licence issued under RAQ
  • Regulatory correspondence & inspections
  • Post-market surveillance & renewals
Learn more about MAH
Tailored timeline Free consultation
For Foreign Manufacturers

Your Marketing Authorization Holder in Sri Lanka

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.

What we take on

  • NMRA product registration in RAQ's name on your behalf
  • Import licence issued under RAQ as license holder
  • Regulatory correspondence and NMRA inspections
  • Adverse event reporting & post-market surveillance
  • Label and artwork compliance review
  • Independent of your distributor (no conflict of interest)
How It Works

Four Simple Steps

Our streamlined process gets your products to market with minimal hassle.

1

Free Consultation

Tell us whether you're a local importer, local manufacturer, or foreign manufacturer - we'll send a tailored proposal within 24 hours.

2

Compliance Review

Our experts assess your product and prepare a documentation roadmap.

3

Documentation

We prepare your complete dossier and handle all NMRA requirements.

4

NMRA Approval

We submit, follow up, and deliver your registration certificate.

Why RAQ

Your Advantage

What sets RAQ Consultation apart.

Local Presence

Office in Kesbewa, direct NMRA liaison

Regulatory Expertise

EU MDR/IVDR aligned, NMRA-compliant

English Communication

Full documentation and updates in English

Time Zone Coverage

Overlap with Asia, EU, and Middle East hours

Tell Us About Your Requirements

Complete this short form and receive a personalised consultation - completely free.

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Your Details
Tell us about your company so we can prepare a personalised consultation.
Your information is encrypted and never shared with third parties. We only use it to prepare your consultation.
We will send your proposal to this email
For quick updates and document sharing
What Service Do You Need?
Select the service that best matches your requirements.

Cosmetic Registration

NMRA product registration for cosmetics, skincare, haircare and fragrances.
3-6 months

Medical Device Registration

NMRA registration for diagnostics, surgical instruments and equipment.
4-8 months

ISO 22716:2007

Cosmetics GMP certification - required for local manufacturers.
Tailored timeline

ISO 9001:2015

Quality management system certification for any organisation.
Tailored timeline

NMRA GMP (Medical Devices)

Good Manufacturing Practice certification for device manufacturers.
Tailored timeline

MAH / Independent License Holder

RAQ acts as your local license holder for NMRA registration and import.
Tailored timeline
Registration Pathway
This determines the documentation requirements and registration process.
The NMRA registration process differs based on whether the product is manufactured in Sri Lanka or imported from abroad.

Local Manufacturing

Product manufactured in Sri Lanka. Requires GMP certification.

Import

Product manufactured abroad and imported to Sri Lanka.

Manufacturing Arrangement
Tell us about your manufacturing setup in Sri Lanka.

Own Manufacturing Site

You own the facility where products are manufactured.

Contract Manufacturing

Products are manufactured by a third-party facility.

GMP / ISO 22716 Certification
The NMRA requires all locally manufactured cosmetics to hold a valid GMP or ISO 22716:2007 certificate.

Yes, we have GMP / ISO 22716:2007

Certificate is current and valid.

No, we do not have GMP certification

We can help you obtain certification first.

GMP Certification Required

NMRA requires a valid GMP / ISO 22716:2007 certificate before product registration can proceed. Don't worry - we offer GMP certification services. Submit this inquiry and we'll include a GMP pathway in your proposal.

Product Information
List your cosmetic products for registration. Each product requires a separate NMRA registration.
1
NMRA GMP Certification
The NMRA requires all locally manufactured medical devices to hold a valid GMP certificate.

Yes, we have NMRA GMP

Certificate is current and valid.

No, we do not have NMRA GMP

We can help you obtain certification first.

GMP Certification Required

NMRA requires a valid GMP certificate before device registration can proceed. We offer GMP certification services - submit this inquiry and we'll include a GMP pathway in your proposal.

Device Information
List your medical devices for registration.
1
Manufacturer & Product Details
Provide details about the manufacturer and the products you wish to import.
NMRA requires legal manufacturer information for all imported products. This helps establish the regulatory chain of responsibility.

Legal Manufacturer

Product Information

1
Review & Submit
Please confirm your details are correct before submitting.
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After submission, you will receive a detailed proposal by email within 24 hours. No payment is required at this stage.
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