NMRA · South & Southeast Asia

Sri Lanka medical device regulatory resources

Every Sri Lanka dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

4 free resources23/25 requirements coveredAug 2026 fees reviewed

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Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Sri Lanka requirements.

Medical device regulation news

Follow recent National Medicines Regulatory Authority (NMRA) policy, guidance, safety, and compliance updates.

Government registration fees

Check the NMRA fee schedule for device registration, certificates, licences, inspections, and advertising approval.

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Structured regulatory requirements

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23 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-08-29

Market entry

D01

Authority & regime

Verified

Competent authority for medical devices: National Medicines Regulatory Authority (NMRA) is the authority responsible for medical devices in Sri Lanka; all devices falling under the Act's definition must be registered with the Auth…
Medical Device Evaluation Committee (MDEC): Technical evaluation of device registration applications is carried out by the Medical Device Evaluation Committee (MDEC), formed under the NMRA Act, considering quality, safety, effectiven…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Primary legislation: The National Medicines Regulatory Authority Act, No. 05 of 2015 is the main legislation controlling medical devices in Sri Lanka.
Consolidated dossier submission process (2025): With effect from 5 August 2025, all new applications for registration of medical devices are accepted as consolidated dossiers, evaluated under the guideline 'Guideline for consolidated dos…

3 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Medical device definition (statutory): Per the NMRA Act as published by NMRA, a medical device is any instrument, apparatus, appliance, software, material or other article, used alone or in combination including software necessa…
IVD medical device definition: An IVD medical device means a device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or prin…

3 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

EU-based risk classes I, IIa, IIb and III for general devices and A-D for IVDs (NMRA GL-037).: Class I, Class IIa, Class IIb, Class III

1 maintained scheme · 2 related facts

Checked 2026-08-25

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D05

Registration pathways

Verified

Consolidated dossier types: Two consolidated dossier types exist for product registration: (1) FMSA + Product Registration Dossier (PRD) for general medical devices and IVDs, and (2) PRD without FMSA for general medic…
Low-risk device registration route: Listed devices, Class I general medical devices and Class A IVDs that are non active, non sterile and without measuring function (Appendix 1 list) follow a simplified registration route und…

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Reliance pathway reference countries: For general medical devices, registrations from USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member countries are considered under the reliance pathway; for IVD medical…

1 source-linked fact

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Marketing Authorization Holder (local agent) requirement: All foreign medical device manufacturers must submit registration applications through a Marketing Authorization Holder (local agent) in Sri Lanka who is responsible for registration, licen…
Applicant responsibilities: The applicant (manufacturer or importer) must give a written statement confirming responsibility for the safety, quality and effectiveness of the registered device, keep application informa…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Foreign Manufacturing Site Application (FMSA): Foreign manufacturing sites require NMRA approval: a Site Master File must be submitted along with all applications for FMSA of medical devices, together with the FMSA application form, loc…
Import licence issuance: After MDEC decision and CEO approval, approved product registration applications are forwarded to the NMRA Licensing Division, which issues the Registration Certificate and the Import Licen…

4 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Common administrative and technical documents: Mandatory common documents: Letter of Authorization from the legal manufacturer (tabulated if multiple local agents, with product range and site), declaration letters (dossier type, sample…
Product Registration Dossier technical documents: PRD technical documents include application Forms A and B and Form C (SIL), device details from the manufacturer, declaration of conformity / EC full quality assurance certificate, STED per…

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Official form or portal surface: submissionSurface: NMRA online Google Form pre submission followed by physical dossier at the Dossier Accepting Point (2nd Floor NMRA); two copies of the relevant checklist must accompany t…
Dossier number formats: Dossier reference numbers indicate route: D/Serial Number (non reliance listed/general/IVD), D/Serial Number/F (non reliance with FMSA), D/Serial Number/RLC (reliance general medical device…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Patient Information Leaflet in three languages: A Patient Information Leaflet in Sinhala, Tamil and English languages is required for point of care medical devices; product labels (original/artwork/draft) and IFU (if applicable, per pres…

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

ISO QMS certificate requirements: An ISO quality management system certificate is a common technical requirement: listed devices — ISO 13485:2016/2021 or ISO 9001:2015 (foreign sites); low risk listed devices locally — ISO…
GMP inspection waiver for listed and Class 1 local manufacturers: NMRA waived the GMP inspection requirement for local manufacturing sites of listed and Class 1 medical devices: manufacturers submit a Site Master File to the Manufacturing Regulatory Divis…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

Atomic Energy Regulatory Council licence to use ionizing radiation: Radiation
Council approval of the facility plan: Radiation
Council import approval extending to X-ray machines and accelerators: Radiation

9 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

New application processing fee - foreign applicant: USD 1,000
New application processing fee - local applicant: USD 250–750

17 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Unresolved

Deficiency stop-clock rule: If deficient data or samples are requested, the applicant must submit the required information and the relevant payment within two (2) months from the date of the notification email, to the…

1 source-linked fact

Checked 2026-08-25

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D16

Approval validity & renewal

Verified

Full registration validity (5 years): Full registration of devices is valid for five (5) years as specified in the certificate; renewal of registration is to be done every five years.
Provisional registration (1 year): Provisional registration may be granted for one year for e.g. new devices, new specifications, new manufacturers, agency transfers, suspended products, or applications lacking required docu…

3 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Post-approval variation prior approval: Any change in product name, product specifications, packaging, indications, contents of product label, package insert or product literature, or any relevant particulars of a registered prod…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Public list of registered medical devices: NMRA publishes a public 'List of NMRA Registered Medical Devices' (current version valid as of 09/07/2026) on its medical devices hub.

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Performance/clinical evaluation exemption (2021 reliance decision): NMRA decided to use the regulatory reliance principle and exempt performance evaluation (clinical evaluation/sample evaluation) to expedite registration: one year provisional registration f…
End-user (sample) evaluation waivers: End user evaluation is waived for applications processed under the Reliance Pathway, and low risk devices (listed, non sterile/non active/non measuring Class I and Class A IVD) are exempt f…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Waiver of Registration (WOR): NMRA operates a Waiver of Registration (WOR) mechanism for medical devices: applications (WOR form, request letter, invoices, LOA, product literature, labels, test reports, free sale certif…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Manufacturer/MAH post-market obligations: The applicant (manufacturer or importer) must confirm responsibility for the safety, quality and effectiveness of the registered device, keep information up to date, maintain a proper syste…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Adverse event reporting channel: Healthcare professionals (doctors, dentists, pharmacists, nurses) are encouraged to report suspected adverse events encountered in practice via the NMRA ADR Google form; a copy of the form…

1 source-linked fact

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

MAH 24-hour recall notification: The marketing authorization holder shall voluntarily recall a product if any evidence appears casting doubt on its quality, efficacy or safety, and shall inform the Authority within 24 hour…
Recall classes and completion timeframes: Recalls are classified by hazard: Class I (life threatening or serious risk) — cease sale/distribution within 24 hours and complete physical recall within 72 hours; Class II (mistreatment o…

3 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising prior written approval: Any person who wishes to advertise or promote a medicine, medical device or borderline product must obtain prior written approval of the Authority; devices may not be advertised or promoted…

1 source-linked fact

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeal against rejected registration: If an application fails in the evaluation/committee process, the local agent can appeal for the registration.
Deficiency communication and response: Deficient documents or data are communicated to the applicant by email through the evaluation report; the applicant must submit the required deficient data or documents with the relevant pa…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (17 lines) →

NMRA registration fees in USD · reviewed 2026-08-25

Fee line	Amount	Provenance
New application processing fee - foreign applicant	USD 1,000	Verified
New application processing fee - local applicant	USD 250–750	Verified
Registration renewal after five years	USD 200–750	Verified
Certificate of registration valid for five years	USD 100–400	Verified