Local regulatory support
MAH and local regulatory support in Sri Lanka
An overseas manufacturer may prepare the product dossier, but a properly appointed Sri Lankan party has its own regulatory obligations.
RAQ works with manufacturers and their local MAHs or authorised agents on the documents, questions and follow-up involved. We provide consultancy support and do not become the legal MAH merely by being engaged.
At a glance
- The local party: The National Medicines Regulatory Authority (NMRA) identifies a local Marketing Authorization Holder (MAH) or authorised agent for relevant overseas medical-device, cosmetic and borderline-product applications.
- Responsibilities: The MAH's obligations are defined by the applicable NMRA requirements and the formal appointment. A consultancy agreement does not, by itself, transfer them to RAQ.
- Categories differ: Appointments, changes in local agency and rights to submit are evaluated under the rules for each product category.
- RAQ's role: Regulatory review, documentation and coordination for the manufacturer and the appointed local party, within an agreed scope.
What is the MAH responsible for?
Local authorisation involves continuing responsibilities
Depending on the applicable product category, the nominated Marketing Authorization Holder or authorised local agent may be responsible for applications, product information, regulatory correspondence, import-related licensing and relevant post-market activities. The obligations are defined by the applicable NMRA requirements and the formal appointment.
A consultancy agreement does not, by itself, transfer those legal responsibilities to RAQ.
What the NMRA publishes for medical devices
For medical devices, the NMRA states that the applicant (the MAH) must:
- be fully responsible for the product and all information submitted in support of the application;
- make sure the information is accurate, complete and authentic;
- provide additional data or clarification when the NMRA asks for it during evaluation;
- inform the NMRA promptly of relevant changes, such as changes to the product, the manufacturing process, safety, quality or effectiveness data, compliance with good manufacturing practice, or regulatory status in other countries.
After registration, changes to registered particulars need the NMRA's prior approval, and the registration certificate and import licence are issued to the applicant.
The Medical Devices and Borderline Products pages describe the MAH as the local agent responsible for the registration, licensing, importation, sale and distribution of the product and for handling quality failures. The Cosmetics page does not set out the MAH's responsibilities in the same detail; it states that the marketing authorization holder may appeal a rejection within one month. The device list above should not be assumed to apply word for word to cosmetics or borderline products.
How RAQ supports the process
Useful support without blurred responsibilities
- 01
Before an application
We help identify the applicable route, required appointments and the documents to request from the manufacturer.
- 02
During dossier preparation
We assess document completeness and help organise information and correspondence between the parties.
- 03
During evaluation
We support the responsible applicant with responses and documentation follow-up within the contracted scope.
- 04
After registration
We can assist with applicable variations, renewal documentation and regulatory change coordination where requested.
RAQ does not import, store, sell or distribute products. The NMRA decides applications; RAQ cannot guarantee approval or an approval date.
Choosing and working with a local party
Define the roles before starting the dossier
| Party | What to establish |
|---|---|
| Manufacturer and legal manufacturer | Confirm who is responsible for the product and who can issue the required technical documents and authorisations. |
| Brand owner | Identify whether the brand owner and manufacturer are different organisations and whether further authorisation is required. |
| Sri Lankan applicant or MAH | Establish the entity legally entitled and responsible to submit or maintain the application under the relevant procedure. |
| Importer and distributor | Clarify who will import and distribute products and what responsibilities arise after registration. |
| RAQ Consultation | Agree the regulatory review, documentation and coordination tasks that RAQ will perform on behalf of the client or in support of the relevant local party. |
How the NMRA's documents name each role
- Legal manufacturer: the term used for medical devices. The letter of authorization comes from the legal manufacturer.
- Manufacturer: used for cosmetics and borderline products. For borderline products, the manufacturer issues the letter of authorization; for cosmetics, the manufacturer declares that no other importer is registered for the product.
- Brand owner: named in the cosmetics documents only, as the issuer of the authorisation letter. The device and borderline pages do not use this term.
- Importer: the NMRA refers to importers, for example in its adverse-event reporting forms for devices, but these pages do not set out an importer role separate from the MAH.
- Local applicant: for locally made cosmetics, the NMRA states that the product owner submits the files.
- Regulatory consultant: the NMRA pages we reviewed do not describe a role for regulatory consultants. A consultant such as RAQ is not the applicant or the MAH.
Where the exact legal term for a role matters to your arrangement, it should be confirmed with the NMRA for your product.
What the manufacturer provides
- Authorising the local agent: the letter of authorization, in the form the NMRA asks for in each category.
- Manufacturer declarations: for devices, a declaration from the legal manufacturer on its other manufacturing sites and, for site applications, a declaration covering local representation, site status, readiness for inspection and the accuracy of the documents. For cosmetics, the declaration that no other importer is registered in Sri Lanka.
- Manufacturing site evidence: quality system or GMP certificates for the site, as each category requires.
- Product information: device details, formulas, labels and other technical documents the local agent submits.
- Safety reporting: for medical devices, the NMRA publishes separate adverse-event reporting forms for manufacturers and for importers and suppliers.
Local-agent documents the NMRA lists, by category
- Medical devices: letter of authorization from the legal manufacturer; a declaration from the local agent on the dossier type; the local agent's business registration. For site applications, also a copy of the Board of Directors' registration (if applicable) and company registration (Form 01/15/40).
- Cosmetics: authorisation letter from the brand owner naming the local agent; the manufacturer's declaration that no other importer is registered in Sri Lanka.
- Borderline products: local agent profile, created before classification; letter of authorization from the manufacturer, addressed to the NMRA's Director General / CEO.
The NMRA pages do not state that the local agent must hold a particular licence of its own beyond these documents. Confirm the position for your product with the NMRA.
Before an appointment: points RAQ recommends considering
- Who holds the registrations: the MAH holds them, so decide whether your distributor or a separate company should take the role.
- Changing partners later: check what the NMRA asks for in your category when a product moves between local agents (see section 04).
- Your documents: decide which technical documents the local agent will hold, and on what confidentiality terms.
- A written agreement: set out responsibilities for registrations, renewals, changes, quality issues, adverse events and ending the appointment.
Category-specific arrangements
The same appointment language does not fit every product
Medical devices
The NMRA publishes specific requirements for the Sri Lankan MAH or authorised local agent, including responsibility for submitted information and applicable changes.
Authorisation and change of local agent
The letter of authorization from the legal manufacturer is mandatory. If the manufacturer has appointed more than one local agent, a tabulated letter listing all local agents, the product range and the manufacturing site is required.
The NMRA's document lists refer to an agency transfer letter issued by the NMRA, where applicable, and, for a waiver of registration, a no-objection letter from the local agent where the product is already registered to another local agent. The Medical Devices page does not list further documents for an agency transfer.
Manufacturing site
Each foreign manufacturing site needs a separate site application, which the local agent submits, except that the NMRA exempts listed medical devices from manufacturing site registration for foreign manufacturers.
Cosmetics
Imported cosmetic products are submitted through the relevant local MAH or authorised party, with the required authorisation and supporting documents.
Authorisation and change of local agent
The authorisation letter is an original issued by the product (brand) owner within a three-year period. It identifies the brand owner, the product and brand name, the manufacturer and the local agent, and may be a sole-agent or a tabulated letter.
The Cosmetics page does not describe a procedure for changing the local agent or importer.
Manufacturing site
Imported products first need a sample import licence, then registration. For the manufacturing site, the NMRA asks for a valid ISO 22716:2007 certificate or a GMP certificate issued by the cosmetic regulatory body of the country of origin.
Borderline products
Imported borderline-product applications have their own local-agent and documentation requirements, which must be checked with the relevant NMRA division.
Authorisation and change of local agent
The letter of authorization comes from the manufacturer. Where a manufacturer has several local agents, a list of the appointed agents and an approved product list must be provided. The local agent's profile must be created before the product's preliminary evaluation (classification).
The Borderline Products page does not describe a procedure for changing the local agent.
Manufacturing site
Imported products go through classification, a sample import licence and registration. Each foreign manufacturing site needs a separate application, reviewed as a desk review that includes the site master file.
Appointments, changes in local agency and rights to submit must be evaluated under the rules relevant to each product category.
Where the NMRA has not published a change procedure, the steps for a particular product are confirmed with the NMRA before any change is made.
FAQs
Frequently asked questions
Does RAQ automatically act as the MAH for our products?
No. RAQ provides independent consultancy and coordination support unless a separate, legally valid arrangement expressly establishes a different role.
RAQ Consultation supports international manufacturers with Sri Lankan regulatory requirements, documentation, NMRA applications and coordination with appropriately authorised local agents. Formal representation arrangements are assessed separately according to applicable regulatory requirements.
Can an overseas manufacturer submit directly without a local party?
The NMRA's published requirements identify a local MAH or authorised agent for relevant overseas medical-device, cosmetic and borderline-product applications. The exact arrangement depends on the product category.
Can the local agent be changed after registration?
Changes may be subject to the NMRA's agency-transfer or other applicable procedures and supporting documents. The current requirements should be checked before making contractual or operational changes (see section 04).
Who responds to post-market or safety matters?
The appointed responsible parties retain the obligations imposed by the applicable legal and regulatory framework. RAQ may assist with communication and documentation under an agreed engagement.
Will RAQ import or distribute our products?
No. RAQ does not import, store, sell or distribute products. Those activities are carried out by licensed parties you appoint.
How long does registration take?
It depends on the product, its pathway and the completeness of the file. The NMRA decides applications and their timing; RAQ cannot guarantee approval or an approval date.
Official sources
- NMRA: Medical Devices (opens in a new tab) ↗
- NMRA: Cosmetics (opens in a new tab) ↗
- NMRA: Borderline Products (opens in a new tab) ↗
- NMRA: Manufacturing sites (opens in a new tab) ↗
- NMRA: Revised checklist F-MDR-035 (opens in a new tab) ↗
The information on this page is general guidance based on publicly available requirements. The applicable procedure and documents should be checked against the current NMRA publications and the individual product circumstances. RAQ is an independent consultancy and does not issue regulatory approvals.
Start a conversation
Need local regulatory support for your products in Sri Lanka?
Tell us the product category, country of manufacture, proposed Sri Lankan applicant and the local regulatory support required. We can discuss an appropriate scope of work.
Please do not send sensitive formulations or full technical dossiers in your first message.