Medical Devices
Device categorisation, manufacturing-site records, consolidated dossiers and the questions that arise during evaluation. We work with manufacturers and their appointed Sri Lankan applicants to put the right evidence together.
Independent regulatory consultancy
Regulatory Affairs & Quality Assurance in Sri Lanka
Bringing a product to the Sri Lankan market starts with understanding what the regulator expects. RAQ Consultation works with manufacturers, importers and brand owners on medical device, cosmetic and borderline-product requirements, from an initial review of the route to dossier preparation and regulatory follow‑up.
Straight answers. Well-prepared documents. Responsibilities made clear.
- Product areas
- Medical devices
Cosmetics
Borderline products - Quality systems
- ISO 22716:2007
ISO 13485
GMP readiness - Based in
- Panadura, Sri LankaIndependent consultancy
Regulatory services
Three product categories. Different regulatory routes.
A medical device dossier is not a cosmetic dossier, and a borderline-product classification is not a product registration. We help clients recognise those differences early, before time is spent preparing the wrong information.
Cosmetics
From imported skincare to locally made cosmetics, we review ingredients, claims, labels, manufacturing evidence and the documents needed for the relevant registration route.
Borderline products
Not sure which category your product falls into?
Borderline Products
When a product sits between established categories, its formulation, intended use and claims need careful assessment. We help prepare the information for NMRA classification and the steps that follow.
For overseas manufacturers, RAQ advises on Sri Lankan requirements, prepares documentation and coordinates applications with the appointed Marketing Authorization Holder (MAH) or local agent. MAH and local regulatory support
RAQ prepares and supports applications for its clients. Registration and classification decisions are made by the NMRA.
Who we help
Your role changes the requirements
Two businesses selling the same product may not have the same regulatory responsibilities. We establish who owns the brand, who manufactures the product, who imports it and who is formally accountable in Sri Lanka.
International manufacturers
Understand local representation, documentation and the applicable product-registration route.
Importers and distributors
Identify the information and authorisations needed to support lawful importation and marketing.
Private-label brands
Clarify the roles of the brand owner, legal manufacturer, manufacturing site and local applicant.
Local manufacturers
Plan manufacturing-site compliance and product-registration activities in the correct order.
How we work
A clear process, without unnecessary complications
We begin with the product and the people responsible for it. Once those facts are clear, we can agree on the documents to review, the work to be done and the next regulatory step.
- 01
Initial assessment
We review the product type, intended use, manufacturing arrangements and the client's role.
- 02
Scope and document review
We identify the applicable NMRA pathway, available documents and gaps requiring attention.
- 03
Application preparation
Within the agreed scope, we assist with dossier organisation, documentation and submission coordination.
- 04
Regulatory follow‑up
We support responses to questions, applicable variations and continuing compliance activities.
This describes how RAQ manages consultancy work. It is not an official NMRA application flowchart. Regulatory decisions and processing times remain with the NMRA, and RAQ cannot guarantee approval or a specific timeline.
Quality assurance & GMP
Quality starts before registration
A convincing dossier depends on what happens at the manufacturing site. We work with manufacturers on quality-system gaps, SOPs, internal audit preparation and practical improvements to their existing controls.
ISO 22716
Cosmetic GMP and manufacturing-site readiness.
Medical-device quality systems
ISO 13485 and applicable quality-system documentation.
ISO 9001
General quality-management implementation and improvement.
Local medical-device and borderline-product sites need NMRA manufacturing-site approval and GMP evidence; local cosmetic sites follow the NMRA acknowledgement and ISO 22716:2007 certification route. An ISO certificate does not replace NMRA site approval. RAQ provides consulting, implementation support and audit preparation; it does not conduct NMRA inspections, issue NMRA GMP approvals or certificates, or award ISO certification.
Regulatory insights
Regulatory developments, explained clearly
A new checklist or notice can change how an application is prepared. Our articles explain selected developments and link back to the original NMRA publications.
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.
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.
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.
Contact
Tell us what you are working on
A product name, its intended use, manufacturing country and your current stage are enough to begin a conversation. We will explain what information is needed to assess the next step.
Please do not send confidential documents
Our contact details are for initial enquiries only. Do not include formulations, technical dossiers, patient information or other confidential material.
- info@raqsl.com
- Hotline
- +94 72 090 6020
- +94 72 090 6020
- Address
- No. 18, Walana, Panadura, Sri Lanka
What to include in your first message
You do not need a full dossier to make an enquiry. Start with:
- The product and its intended use.
- The country where it is manufactured.
- Your role, such as manufacturer, importer, distributor or brand owner.
- Whether the product is already registered or at an earlier development stage.
- The main regulatory question or service you need.
Please keep the first enquiry non-confidential. Do not include complete formulas, technical dossiers, identification documents or sensitive business records. If we need those materials later, we will agree on how they should be shared.