Who we help
International Manufacturers
Overseas manufacturers of medical devices, cosmetics and borderline products planning to supply the Sri Lankan market.
Common difficulties
- Not knowing which National Medicines Regulatory Authority (NMRA) route applies to each product, or whether a product falls into a different category.
- Certificates and authorisation letters that name different legal entities, sites or product ranges.
- Understanding the role of the local Marketing Authorization Holder that the NMRA requires for foreign manufacturers.
How RAQ can assist
RAQ reviews product eligibility and the likely registration route, checks your existing documents against current NMRA requirements, and coordinates documentation and registration work with your appointed Marketing Authorization Holder in Sri Lanka. Formal representation arrangements are assessed separately according to applicable regulatory requirements; see MAH and local regulatory support.
Next step: send a product list with intended uses, the legal manufacturer and manufacturing sites, and the registrations you already hold.
Contact RAQ
Discuss your project
Tell us your role, the products involved and where they are made. We will reply with a suitable next step.
Please do not send formulations, confidential dossiers or other proprietary information in a first message.