Regulatory Resources

RAQ is an independent consultancy. This page is a directory and does not replace official NMRA guidance.

Official NMRA references

• Medical devices

  Official medical-device guidance, application forms and notices.

• Cosmetics

  Official imported and local cosmetic product pathways, forms and guidance.

• Borderline products

  Start with the authority's classification and category guidance.

• Announcements

  Check new notices before relying on an older form or checklist.

Common terms used on this website

Plain-language explanations by RAQ, to help you read our pages. They are not official definitions; the NMRA's own publications are authoritative.

Borderline product

A product that combines characteristics of medicines with foods, medical devices or cosmetics. The NMRA classifies it before registration.

Classification report

The NMRA's decision on the category of a borderline product.

Consolidated dossier

A single medical device submission that brings together manufacturing site registration (where required), the sample import licence application and product registration.

CPSR

Cosmetic product safety report: a safety report for a finished cosmetic, signed by a qualified person.

eNMRA

The NMRA's online portal.

FMSA

Foreign Manufacturing Site Application: the NMRA application to approve a foreign medical device manufacturing site.

GMP

Good manufacturing practice.

IAF

International Accreditation Forum, the international association of accreditation bodies.

INCI

International Nomenclature of Cosmetic Ingredients, the standard naming system for cosmetic ingredients.

ISO 13485, ISO 22716:2007, ISO 9001:2015

International standards for medical device quality management, cosmetics good manufacturing practice and general quality management. Certificates are issued by independent certification bodies.

IVD

In-vitro diagnostic medical device.

Letter of Authorization (LOA)

The manufacturer's letter that appoints its local agent in Sri Lanka.

MAH

Marketing Authorization Holder: the local agent in Sri Lanka through which a foreign manufacturer submits applications to the NMRA.

NMRA

National Medicines Regulatory Authority, Sri Lanka's regulator for medicines, medical devices, cosmetics and borderline products.

PRD

Product Registration Dossier.

SIL

Sample import licence: a licence to import samples needed for evaluation.

SLAB

Sri Lanka Accreditation Board.

SLSI

Sri Lanka Standards Institution.

Prepare a useful first enquiry

RAQ recommends a short description of the product, its intended use, where it is manufactured, your role in the supply chain and the support you need. This is an enquiry guide, not an NMRA application checklist.

• Identify whether you are the manufacturer, brand owner, importer or another business partner.
• State whether the product is already registered elsewhere and which documents you currently hold.
• Describe the main question you need answered without attaching confidential dossiers or formulations.

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