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NMRA · structured requirements

🇱🇰 Sri Lanka medical device regulatory data

Explore the medical device requirements currently available for Sri Lanka, organized by topic and linked to official sources.

47 facts23 dimensions11 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising prior written approval

advertising.prior-written-approval
Fact-level verified

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 to the general public for the treatment, prevention or cure of prescribed diseases, disorders or abnormal physical states. The NMRA Advertising Evaluation Sub Committee regulates printed and electronic advertisements.

Conditions
  • Applications accepted Fridays 9.00 a.m.–3.30 p.m. with valid registration certificate and storyboard.
  • Processing fee note quotes 1000 USD (see typed finding).

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Re-registration (renewal) process

renewal.re-registration-process
Fact-level verified

Registration is renewed by re-registration (RR) dossiers: NMRA publishes a Re-Registration Dossier Accepting Checklist (Annex 2) and requires the previous registration certificate in RR dossiers; required acceptance documents are listed in the 30 June 2023 notice.

Conditions
  • Annex 2 'Re-Registration Dossier Accepting Checklist' is published on the NMRA medical devices hub.
  • A 2021 ops notice (e-NMRA outage) stated re-registration applications were accepted manually; treat as historic.

Full registration validity (5 years)

validity.full-registration-5-years
Fact-level verified

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.

Conditions
  • Source is the November 2011 CDDA guideline still published as 'Guidelines for registration of Medical Devices' on the NMRA hub; GL-034/GL-037 do not restate validity — verify certificate at use.

Provisional registration (1 year)

validity.provisional-registration-1-year
Fact-level verified

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 documentation; the 2021 exemption notice also granted one-year provisional (IVDs approved by WHO or reference authorities) and one-year conditional provisional registrations (COVID-19 essential devices) with performance evaluation pending.

Conditions
  • One-year conditional provisional registrations under the 23 Nov 2021 exemption notice apply to WHO/reference-authority-approved IVDs and COVID-19 essential devices.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority for medical devices

authority.competent-authority
Fact-level verified

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 Authority, and licences are required for manufacturing, importation, re-packaging, sale, distribution and offering for sale.

Conditions
  • Applies to all medical devices and IVDs falling under the definition in the NMRA Act.

Confirms and upgrades the baseline fact: same page, now verified to the specific section.

Medical Device Evaluation Committee (MDEC)

authority.technical-evaluation-committee
Fact-level verified

Technical evaluation of device registration applications is carried out by the Medical Device Evaluation Committee (MDEC), formed under the NMRA Act, considering quality, safety, effectiveness, need and cost; approved applications go to the CEO and then the Licensing Division issues certificates.

Conditions
  • MDEC meets monthly to decide applications.
  • MDEC recommendations are forwarded to the CEO for approval (GL-037 section 10.7).

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Post-approval variation prior approval

variation.prior-approval-required
Fact-level verified

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 product must not be made without prior approval of the Authority; registration may be cancelled for unapproved changes, and any change affecting quality, safety and efficacy requires a new registration application.

Conditions
  • Changes affecting quality, safety and efficacy require a new application for registration.

Classification rules

What local class follows from which rules and decisive product facts?

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Classification detail 2

classification.detail-2
Fact-level verified

Low-risk tier = listed devices plus Class I general medical devices and Class A IVDs which are non-active, non-sterile and without measuring function (Appendix 1 product list, e.g. adhesive bandages, hospital beds, bedpans). Sterile/active/measuring Class I and Class A devices are excluded.

Classification scheme (full axis)

classification.scheme-classes
Fact-level verified
Axis

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

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

NMRA

Notes
  • GL-037 Section 5: classification follows the principles and rules of the EU Medical Device Regulations - general devices Listed / Class I / IIa / IIb / III; IVDs Class A / B / C / D.
  • Low-risk tier (GL-037): listed devices plus Class I general devices and Class A IVDs which are non-active, non-sterile and without measuring function (Appendix 1 product list); sterile/active/measuring Class I and Class A devices are excluded from the low-risk route (Section 6 exemptions name Class IIa, IIb, III and IVD Class B, C, D).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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End-user (sample) evaluation waivers

clinical.end-user-evaluation-waivers
Fact-level verified

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 from end-user performance evaluation; non-reliance applications otherwise require samples via the Sample Import Licence upon NMRA request.

Conditions
  • Applies to reliance applications and GL-037 low-risk devices.
  • Samples otherwise submitted upon request of the Authority per applicant declaration (GL-034 section 8.2).

Performance/clinical evaluation exemption (2021 reliance decision)

clinical.performance-evaluation-exemption
Fact-level verified

NMRA decided to use the regulatory reliance principle and exempt performance evaluation (clinical evaluation/sample evaluation) to expedite registration: one-year provisional registration for IVD new applications approved by WHO or WHO reference regulatory authorities (FDA-USA, TGA-Australia, Health Canada, HSA-Singapore, MHLW-Japan); one-year conditional provisional registration with pending performance evaluation for COVID-19 essential non-IVD devices approved by an NMRA reference country; renewal applications for registered devices without complaints or quality issues are also exempt.

Conditions
  • Dossiers must include all necessary documents including original commercial packs/labels.
  • Registration samples in commercial packaging must be supplied if NMRA requires them, except for medical equipment.
  • Decision dated 23 November 2021.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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IVD medical device definition

definition.ivd
Fact-level verified

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 principally to provide information for diagnostic, monitoring or compatibility purposes, including reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.

Conditions
  • Same definition repeated in GL-037 section 8.

Listed devices (lowest tier)

definition.listed-devices
Fact-level verified

Listed devices do not fall under the statutory definition of a medical device; they are characterised by a lack of direct physiological or clinical impact, pose the lowest risk and do not fall into clinical classes I, IIa, IIb or III; NMRA nevertheless registers them under the low-risk route (GL-034: products not falling within the definition of medical devices but used for personal hygiene or general medical purposes).

Conditions
  • GL-034 (eff. 23.07.2025) words it as products used for personal hygiene or general medical purposes.
  • Listed devices are exempt from foreign manufacturing site registration.

Medical device definition (statutory)

definition.medical-device
Fact-level verified

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 necessary for its proper application, intended by the manufacturer for use in or on human beings for diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; or control of conception; and which does not achieve its intended action by pharmacological, immunological or metabolic means. Ayurveda devices and Homeopathy devices are excluded.

Conditions
  • Software covered where necessary for proper application of the device.
  • Excludes Ayurveda devices and Homeopathy devices.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Common administrative and technical documents

dossier.common-documents
Fact-level verified

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 submission on request), agency transfer letter if applicable, a valid original Free Sale Certificate (or QR/web-link verification at fee payment), NMRA GMP report for local manufacturers if applicable, FMSA approval or product registration certificate, ISO QMS certificate, and foreign country registration evidence.

Conditions
  • ISO certificate: Listed device — ISO 13485:2016/2021 or ISO 9001:2015; all other medical devices — ISO 13485:2016/2021.
  • Dossiers must be in a box file with green tape, pages numbered, indexed, with responsible regulatory-affairs person details.

Product Registration Dossier technical documents

dossier.prd-technical-documents
Fact-level verified

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 GHTF, Essential Requirement checklist per GHTF, risk analysis report (e.g. ISO 14971), COA or finished-product test report, stability data, sterility/EO/package-integrity reports for sterile devices, biological evaluation report, clinical evaluation test report if applicable, electrical safety and EMC data for active devices, metrology certification for measuring devices, Atomic Energy Authority approval for radiation-emitting devices, software verification and validation report, BSE report for animal-derived materials, labels, catalogue, IFU and PIL, and IVD performance evaluation reports.

Conditions
  • If CE marked: EC design examination certificate if applicable.
  • IVDs: performance evaluation test report (analytical, clinical).
  • PIL required in Sinhala, Tamil and English for point-of-care devices.

New and re-registration dossier acceptance documents (2023 notice)

dossier.re-registration-documents
Fact-level verified

For acceptance of new dossiers and re-registration dossiers, importers must submit: comprehensive table of contents (index), application form signed by authorized person (Schedule 1 Form A/Form B), LOA from legal manufacturer, FMSA approval copy if applicable, NMRA GMP report for local products, copy of sample licence (new) / previous registration (RR), original free sale certificate, hygienic certificate if applicable, ISO certificate, EC certificate, EC design examination certificate if applicable, COA, stability report, sterility report, EO residual report, electrical safety data, IVD performance evaluation report, biological evaluation report, third-party test report, BSE report, Atomic Energy Authority approval for radiation-emitting devices, other-country registration evidence list, accessories list, IFU for IVD kits, and labels/catalogue.

Conditions
  • Items marked if applicable depend on device type.
  • Notice addressed to all importers of medical devices.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Applicant responsibilities

applicant.responsibilities
Fact-level verified

The applicant (manufacturer or importer) must give a written statement confirming responsibility for the safety, quality and effectiveness of the registered device, keep application information up to date, have a proper system to handle side effects or problems, carry out quality control checks and use suitable packaging materials.

Conditions
  • Applies to all applicants for device registration.

Marketing Authorization Holder (local agent) requirement

mah.foreign-via-local-agent
Fact-level verified

All foreign medical device manufacturers must submit registration applications through a Marketing Authorization Holder (local agent) in Sri Lanka who is responsible for registration, licensing, importation, sale, distribution, handling of quality failures and all aspects pertaining to the device in Sri Lanka.

Conditions
  • Applies to all foreign manufacturers.
  • Local agent details (business registration, Board of Directors registration, Company Registration Form 01/15/40) are required in the dossier.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Foreign Manufacturing Site Application (FMSA)

establishment.foreign-site-approval
Fact-level verified

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, local agent business registration documents and manufacturer declarations. Listed medical devices are exempt from foreign manufacturing site registration.

Conditions
  • Applies to foreign manufacturing sites for general medical devices and IVDs.
  • Listed devices exempt.
  • Upon FMSA approval MDRD emails the approval plus Schedule IV Form C to process the Sample Import Licence.

Import licence issuance

import.licence-issuance
Fact-level verified

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 Licence to the applicant.

Conditions
  • Import licence is issued after device registration.
  • Same step described in GL-037 section 10.7 for low-risk devices.

Sample Import Licence (SIL)

import.sample-import-licence
Fact-level verified

A Sample Import Licence is obtained through the NMRA Licensing Division using the approved Schedule IV Form C and evaluation sheet: the applicant submits the scanned approved form to the Licensing Division, pays the SIL fee, and must submit a copy of the SIL and a request letter to the accepting point to initiate evaluation.

Conditions
  • SIL payments handled by the NMRA Licensing Division.
  • Samples must be supplied upon NMRA request (applicant declaration), except medical equipment per the 2021 exemption notice.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Patient Information Leaflet in three languages

label.pil-three-languages
Fact-level verified

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 prescribed guideline) are dossier requirements.

Conditions
  • Applies to point-of-care medical devices.
  • Legacy 2011 guideline similarly required IFU in English, Sinhala and Tamil for e.g. glucometers, hearing aids, ear and forehead thermometers.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Manufacturer/MAH post-market obligations

pms.side-effect-handling-system
Fact-level verified

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 system to handle side effects or problems with the product, perform quality control checks and use suitable packaging; MAHs must also handle quality failures for foreign manufacturers.

Conditions
  • Ongoing compliance required throughout the product lifecycle.
  • MAH responsibility for quality failures stated on the NMRA medical devices hub.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Dossier number formats

submission.dossier-number-formats
Fact-level verified

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 devices except Class I, and IVDs), D/Serial Number/RLC/F (reliance with FMSA), D/Serial Number/L (locally manufactured, with NMRA GMP audit); low-risk dossiers use D/Serial Number/LR.

Conditions
  • Low-risk format D/Serial Number/LR per GL-037 section 10.5.

Official form or portal surface

submission.official-form-or-portal-surface
Fact-level verified
Submission Surface

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 the dossier

Acceptance Window

Every Tuesday, 9:00 a.m. to 3:00 p.m.

Forms
  • Application form A
  • Application form B
  • Application form C for Sample Import License
  • Application for registration of Foreign Manufacturing Site (FMSA)
  • Application for Waiver of Registration (WOR)
  • Annex 1 consolidated new dossier checklist
  • Annex 2 re-registration checklist
  • F-MDR-046 low-risk checklist
Note

An e-NMRA digital platform exists but the current hub prescribes the Google Form + physical dossier route

Conditions
  • Describes the current official submission surface as of the checked date.

Confirms baseline; incomplete submissions are not accepted for evaluation.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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GMP inspection waiver for listed and Class 1 local manufacturers

qms.gmp-inspection-waiver-listed-class1
Fact-level verified

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 Division (Thursdays) and receive a GMP Waiver Document to attach to product registration in place of GMP approval. A two-year blanket GMP approval (10 May 2025 – 9 May 2027) allows manufacturers to obtain ISO 9001; after 9 May 2027 NMRA will only accept ISO 9001 in lieu of GMP inspection for these categories.

Conditions
  • Applies to local (Sri Lankan) manufacturers of listed and Class 1 devices on the attached list.
  • Effective window 10/05/2025 to 09/05/2027.

Effective from 2025-05-10 · Effective until 2027-05-09

ISO QMS certificate requirements

qms.iso-certificate-requirements
Fact-level verified

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 9001:2015 accredited by SLAB or equivalent competent body; Class I low-risk and Class A IVD devices — ISO 13485:2016/2021 (local sites: SLAB-accredited or equivalent); all other medical devices — ISO 13485:2016/2021.

Conditions
  • New local manufacturers may submit with ISO 9001 and must submit ISO 13485:2016 within two years (checklist remarks).
  • GL-034 section 8.3: listed device — ISO 13485:2016/2021 or ISO 9001:2015; other devices — ISO 13485:2016/2021.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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NMRA recall initiation and alert basis

recall.authority-initiation
Fact-level verified

NMRA initiates recalls of any medicine, medical device or borderline product manufactured, sold, stored or distributed in, or imported into Sri Lanka that is unsafe or defective; it may also act on MDEC/MEC/BPEC recommendations and on safety alerts issued by the WHO or any other national regulatory agency, and can temporarily withhold a product where defectiveness is doubtful.

Conditions
  • Applies to medicines, medical devices and borderline products.
  • NMRA publishes drug alert notices on its website and via mass media where necessary.

Effective from 2021-02-01

Recall classes and completion timeframes

recall.class-timeframes
Fact-level verified

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 or harm, not life-threatening) — up to 10 days; Class III (unlikely to cause harm, e.g. non-compliance) — up to 30 days.

Conditions
  • Recall levels: wholesale, retail and consumer.
  • Class II and III recalls ensured within 10 and 30 days respectively.

Effective from 2021-02-01

MAH 24-hour recall notification

recall.mah-24h-notification
Fact-level verified

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 hours of initiating such voluntary recall; the MAH must recall every defective batch/product in circulation in Sri Lanka.

Conditions
  • Applies to marketing authorization holders of medicines, medical devices and borderline products.
  • MAH maintains a recall log with unique recall reference numbers (Annexure 11).

Effective from 2021-02-01

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Consolidated dossier types

registration.consolidated-dossier-types
Fact-level verified

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 medical devices, IVDs and listed devices (foreign and local manufacturers). A consolidated dossier combines manufacturing site registration, sample import licence application and product registration in a single file. Listed medical devices are exempt from foreign manufacturing site registration.

Conditions
  • PRD without FMSA is used where the foreign site already holds FMSA approval, or for listed devices or local manufacturers.
  • Dossier numbers: D/Serial (non-reliance), /F (with FMSA), /RLC (reliance), /RLC/F, /L (local, NMRA GMP audit).

Low-risk device registration route

registration.low-risk-route
Fact-level verified

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 under GL-037: they are exempt from manufacturing site registration (foreign sites), GMP inspection (local sites) and end-user performance evaluation; dossiers are numbered D/Serial Number/LR.

Conditions
  • Applies only to the product list in Appendix 1 of GL-037.
  • Sterile, active or measuring Class I / Class A devices are excluded and follow the standard route.

Effective from 2026-05-13

Market-access route or official registration surface

registration.market-access-route
Fact-level verified
Route

Register device with NMRA (consolidated dossier) via local agent; then Licensing Division issues Registration Certificate and Import Licence

Submission Surface

Online Google form pre-submission, then physical consolidated dossier (two copies of checklist) at the Dossier Accepting Point, 2nd Floor NMRA, Tuesdays 9:00 a.m.–3:00 p.m.

Foreign Manufacturer Route

Mandatory Sri Lankan Marketing Authorization Holder (local agent)

Low Risk Route

Simplified route for listed devices, non-sterile/non-active/non-measuring Class I and Class A IVDs (GL-037)

Reliance Route

Reliance Pathway for products registered with a Reference NRA (web notice eff. 29.10.2025)

Conditions
  • Describes the current official route and surface as of the checked date.

Confirms baseline value; enriched with the named routes and acceptance window.

Reliance pathway for new applications (2025)

registration.reliance-pathway
Fact-level verified

From 29 October 2025 NMRA considers eligible new device applications under a Reliance Pathway, relying on assessment and approval decisions of recognized Reference NRAs when sufficient regulatory evidence is available. Eligible if: (1) product registered with the NRA of the country of manufacture, (2) registered with the NRA of the legal manufacturer's country, or (3) product registered with any NMRA Reference NRA. End-user evaluation is waived and evaluation is shorter; all other procedures, requirements and fees remain unchanged.

Conditions
  • Applies to new applications only (not renewals or variations).
  • Applies to both general medical devices and IVDs.
  • Eligibility verified via Schedule 1 Form A and the Letter of Authorization.
  • Applications not qualifying proceed under standard evaluation.

Effective from 2025-10-29

GL-034 dossier-number table marks reliance route 'Reliance General Medical Devices (except Class I) and IVDDs' — D/Serial Number/RLC.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Sri Lanka approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Sri Lanka (2 records)

Sri LankaNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference
Pending verification
Statement

NMRA's reliance pathway considers registrations only from the USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member states (plus Singapore for IVDs). China/NMPA is not a recognized reliance country, so a China NMPA certificate does not open the reliance pathway and the device follows the standard consolidated-dossier evaluation.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

sri-lanka

China Classes In Scope

All device classes (general medical devices and IVDs)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • General devices: USA, UK, Australia, Canada, Japan, Norway, Switzerland, all EU member countries
  • IVDs: same list plus Singapore
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2025-07-23

Source passage: Reliance Pathway - Recognized Countries: For General Medical Devices, registration from the following countries will be considered under the reliance pathway: USA, UK, Australia, Canada, Japan, Norway, Switzerland & All European Union (EU) member countries. For In Vitro Diagnostic (IVD) Medical Devices: USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries

Sri LankaEU conformity assessment · Australia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · Singapore HSA · US FDA · UK MHRA · Norway

Regulatory reference

Reliance pathway reference countries

reliance.reference-countries
Fact-level verified

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 devices the same list applies plus Singapore.

Conditions
  • IVD list: 'USA, UK, Australia, Canada, Japan, Norway, Switzerland, Singapore & All European Union (EU) member countries'.
  • Reference NRA evidence: product registration certificate or free sale certificate issued by the reference authority.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Deficiency stop-clock rule

review.deficiency-stop-clock
Fact-level verified

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 accepting point; on failure the application is given 'awaiting data' status and the evaluation report goes to the Medical Device Evaluation Committee.

Conditions
  • Same rule in GL-037 section 10.6: 'within two months from the date of the email to the accepting point'.
  • Deficiencies are communicated by email through the evaluation report.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Waiver of Registration (WOR)

wor.waiver-of-registration
Fact-level verified

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 certificate, ISO certificate, CE self-declaration/EC certificate, plus e.g. TEC and procurement committee approvals where applicable) are submitted to the office of the State Ministry of Production, Supply and Regulations and Pharmaceuticals; incomplete applications are not tabled to the WOR Committee. NMRA publishes lists of issued WORs (e.g. IR thermometers, PCR kits, pulse oximeters).

Conditions
  • Used for products such as IR thermometers, PCR kits and pulse oximeters (issued-WOR lists published).
  • Separate medicines-specific WOR exists under section 109 of the NMRA Act for unregistered medicines in special circumstances.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Deficiency communication and response

submission.deficiency-response
Fact-level verified

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 payment within two months from the date of the email to the accepting point, failing which the application is given 'awaiting data' status.

Conditions
  • Rejected or awaiting-data evaluation reports are forwarded to the MDEC.
  • Additional payments accompany deficiency responses.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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Adverse event reporting channel

vigilance.adverse-event-reporting
Fact-level verified

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 is forwarded to the Adverse Drug Reaction Monitoring Unit, Department of Pharmacology, Faculty of Medicine, University of Colombo.

Conditions
  • Reporting channel is voluntary/encouraged wording; no device-specific reporting deadline is published on the hub.
  • A copy of the form shall be forwarded to the Adverse Drug Reaction Monitoring Unit (address and contacts published on the page).

Related structured datasets

Classification systems · 1 record
Open EU-based risk classes I, IIa, IIb and III for general devices and A-D for IVDs (NMRA GL-037). →
Id

sri-lanka:medical-device

Jurisdiction Id

sri-lanka

Domains
  • medical-device
  • ivd
Name

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

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

NMRA

Official Domains
  • nmra.gov.lk
Notes
  • GL-037 Section 5: classification follows the principles and rules of the EU Medical Device Regulations - general devices Listed / Class I / IIa / IIb / III; IVDs Class A / B / C / D.
  • Low-risk tier (GL-037): listed devices plus Class I general devices and Class A IVDs which are non-active, non-sterile and without measuring function (Appendix 1 product list); sterile/active/measuring Class I and Class A devices are excluded from the low-risk route (Section 6 exemptions name Class IIa, IIb, III and IVD Class B, C, D).
Source Status

official-source-verified

Source Title

NMRA Guideline GL-037 — Registration of Low Risk Products, Sections 3-6

Source Url

https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a04140e14d44d1d153f4124_New%20Guideline%20for%20low%20risk%20product%20registration.pdf

Verified On

2026-08-25

Source Supports
  • class-axis
  • ivd-class-axis
Registration pathways, prior approvals and planning · 0 records

No maintained record.

Government fee schedules · 1 record
Open Sri Lanka fees →
Jurisdiction Id

sri-lanka

Country

Sri Lanka

Country Code

LK

Authority

NMRA

Low Risk Local
Min

250

Max

250

Currency

USD

Per Product

Yes

High Risk Local
Min

1000

Max

1000

Currency

USD

Per Product

Yes

Details
  • Id

    new-application-foreign

    Item

    New application processing fee - foreign applicant

    Currency

    USD

    Amount Local

    1000

    Amount Local Formatted

    USD 1,000

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    new-application-local

    Item

    New application processing fee - local applicant

    Currency

    USD

    Amount Local

    750

    Amount Local Min

    250

    Amount Local Max

    750

    Amount Local Formatted

    USD 250–750

    Frequency

    Per application

    Notes

    Local Category A USD 750; Local Category B USD 250.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    registration-renewal

    Item

    Registration renewal after five years

    Currency

    USD

    Amount Local

    750

    Amount Local Min

    200

    Amount Local Max

    750

    Amount Local Formatted

    USD 200–750

    Frequency

    Every 5 years

    Notes

    Foreign USD 750; Local Category A USD 500; Local Category B USD 200.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    registration-certificate-five-year

    Item

    Certificate of registration valid for five years

    Currency

    USD

    Amount Local

    400

    Amount Local Min

    100

    Amount Local Max

    400

    Amount Local Formatted

    USD 100–400

    Frequency

    Per certificate

    Notes

    Foreign USD 400; Local Category A USD 200; Local Category B USD 100. A LKR 2,000 stamp duty applies to each certificate.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    provisional-registration-certificate

    Item

    Provisional registration certificate (maximum two years)

    Currency

    USD

    Amount Local

    200

    Amount Local Min

    50

    Amount Local Max

    200

    Amount Local Formatted

    USD 50–200

    Frequency

    Per certificate

    Notes

    Foreign USD 200; Local Category A USD 100; Local Category B USD 50.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    additional-data-evaluation

    Item

    Additional data evaluation

    Currency

    USD

    Amount Local

    500

    Amount Local Min

    100

    Amount Local Max

    500

    Amount Local Formatted

    USD 100–500

    Frequency

    Per evaluation

    Notes

    Foreign USD 500; Local Category A USD 200; Local Category B USD 100.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    variation-review

    Item

    Variation that requires review

    Currency

    USD

    Amount Local

    200

    Amount Local Formatted

    USD 200

    Frequency

    Per variation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    manufacturing-plant-approval-foreign

    Item

    Foreign manufacturing plant approval processing fee

    Currency

    USD

    Amount Local

    1500

    Amount Local Formatted

    USD 1,500

    Frequency

    Per plant

    Notes

    Additional data for plant evaluation: USD 300.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    gmp-inspection-foreign

    Item

    Foreign GMP inspection

    Currency

    USD

    Amount Local

    20000

    Amount Local Min

    15000

    Amount Local Max

    20000

    Amount Local Formatted

    USD 15,000–20,000

    Frequency

    Per inspection

    Notes

    SAARC countries USD 15,000; other countries USD 20,000. Air tickets, visa fees, and in-country transport are borne by the applicant.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    gmp-inspection-local

    Item

    Local GMP inspection

    Currency

    USD

    Amount Local

    300

    Amount Local Min

    100

    Amount Local Max

    300

    Amount Local Formatted

    USD 100–300

    Frequency

    Per inspection

    Notes

    Manufacturing site Category A USD 300, Category B USD 100; packaging/repackaging site USD 100.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    sample-import-licence

    Item

    Sample import licence

    Currency

    USD

    Amount Local

    100

    Amount Local Formatted

    USD 100

    Frequency

    Per licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    import-licence

    Item

    Import licence

    Currency

    USD

    Amount Local

    100

    Amount Local Formatted

    USD 100

    Frequency

    Per licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    free-sale-certificate

    Item

    Free-sale certificate

    Currency

    USD

    Amount Local

    50

    Amount Local Formatted

    USD 50

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    who-gmp-certificate

    Item

    WHO GMP certificate

    Currency

    USD

    Amount Local

    100

    Amount Local Formatted

    USD 100

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    clinical-trial-processing

    Item

    Clinical trial processing fee

    Currency

    USD

    Amount Local

    1000

    Amount Local Min

    0

    Amount Local Max

    1000

    Amount Local Formatted

    USD 0–1,000

    Frequency

    Per trial

    Notes

    Industry sponsored USD 1,000; academic with international sponsorship USD 250; local investigator sponsored free of charge.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    agency-transfer

    Item

    Agency transfer

    Currency

    USD

    Amount Local

    1000

    Amount Local Formatted

    USD 1,000

    Frequency

    Per party

    Notes

    Charged per manufacturer and per new marketing-authorisation holder.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

  • Id

    advertisement-processing

    Item

    Advertisement processing fee (all categories)

    Currency

    USD

    Amount Local

    1000

    Amount Local Formatted

    USD 1,000

    Frequency

    Per advertisement

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Source Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Source Effective Date

    2026-08-01

    Verified On

    2026-08-25

Notes
  • NMRA fixes device fees in US dollars and republishes the schedule monthly with the LKR conversion at the Central Bank selling rate of the last working day of the preceding month; the USD amounts recorded here are the schedule's own base fees.
  • Every line additionally carries 18% VAT and a 2.5% Social Security Contribution Levy, and registration certificates and licences carry a LKR 2,000 stamp duty.
  • Formulation approval for local manufacturers and local investigator-sponsored clinical trials are stated free of charge.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)

    Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf

    Effective Date

    2026-08-01

    Accessed Date

    2026-08-25

  • Title

    NMRA medical devices page, Fees section

    Url

    https://www.nmra.gov.lk/pages/medical-devices

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Sri Lanka certifications →
Slug

sri-lanka

Market

Sri Lanka

Confidence

low

Schemes
  • Id

    aerc-licence-to-use-ionizing-radiation

    Name

    Atomic Energy Regulatory Council licence to use ionizing radiation

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Practice Operator

    Note

    Naming correction worth carrying: the regulator is the Atomic Energy Regulatory Council under the Sri Lanka Atomic Energy Act No. 40 of 2014, which commenced on 1 January 2015 and repealed the Atomic Energy Authority Act No. 19 of 1969, so references to the Atomic Energy Authority are to the predecessor body. The Council regulates sources and practices through authorisation, comprising licensing and approvals, and a licence from the Council is required to use radiation in all activities other than the exempt ones. Its remit is expressly confined to non-power applications in medicine, industry, teaching and agriculture and does not extend to nuclear power plants.

    Source Urls
    • https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&Itemid=185&lang=en
    Source Binding

    candidate

  • Id

    aerc-facility-plan-approval

    Name

    Council approval of the facility plan

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Facility

    Note

    A separate authorisation from the use licence and obtained before it: the Council gives approvals for facility plans as well as for import and export of radioactive sources and irradiating apparatus.

    Source Urls
    • https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&Itemid=185&lang=en
    Source Binding

    reviewed

  • Id

    aerc-import-approval-covers-x-ray-machines

    Name

    Council import approval extending to X-ray machines

    Category

    Ionizing Radiation

    Status

    Mandatory At Import

    Object

    Importer Of Irradiating Apparatus

    Note

    The scope point that catches suppliers out: Sri Lanka's import control is not limited to radioactive material. The Council states that where any radioactive sources or X-ray machines are to be imported or exported, an approval must be obtained from it. So a plain diagnostic X-ray unit with no radioactive source still needs a Council import approval, distinct from both the use licence and the facility plan approval.

    Source Urls
    • https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&Itemid=185&lang=en
    Source Binding

    reviewed

  • Id

    trcsl-vendor-licence-to-deal-in-equipment

    Name

    TRCSL vendor licence to deal in telecommunication or radio equipment

    Category

    Telecom Network Attachment

    Status

    Mandatory Pre Market

    Object

    Local Vendor Importer Or Dealer

    Note

    This is a licence on the trading entity rather than on the product, and it is broad. Under section 21 of the Sri Lanka Telecommunications Act No. 25 of 1991 as amended, TRCSL issues vendor licences to deal in telecommunication or radio equipment, and without such a licence no person may import, sell, offer for sale, deal in hire, lease, demonstrate, maintain or repair any such equipment — so a service or maintenance arrangement for a wireless medical device is caught as well as the sale. Currency caveat: the quoted statement is from TRCSL's own 2016 annual report, which is official but dated, and the current type approval instrument is understood to be the RTTE Type Approval Rules 2020, which could not be opened.

    Source Urls
    • https://www.trc.gov.lk/content/files/reports/AnnualReport2016E.pdf
    Source Binding

    reviewed

  • Id

    trcsl-type-approval-and-clearance-letter

    Name

    TRCSL type approval and customs clearance letter

    Category

    Radio Spectrum

    Status

    Mandatory At Import

    Object

    Radio Or Network Equipment

    Note

    The Networks Division of TRCSL processes requests for type approvals and clearance letters for the importation of network-related equipment, and the approval is held in the name of the local importer rather than the foreign manufacturer. Same currency caveat as the vendor licence: this rests on TRCSL's 2016 annual report because the regulator's current type approval page could not be located, so the 2020 Rules should be checked before relying on the procedure.

    Source Urls
    • https://www.trc.gov.lk/content/files/reports/AnnualReport2016E.pdf
    Source Binding

    candidate

  • Id

    nmra-dossier-electrical-emc-software-evidence

    Name

    NMRA dossier electrical, EMC and software evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    GL-034 §8.4: active medical devices require electrical-safety data and an electromagnetic-compatibility data report (e.g. IEC standard); device software requires a Verification and Validation Report where applicable.

    Source Urls
    • https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6881ba1be938700be5b63a4d_Guidelines%20for%20consoildated%20dossier-%20Version%20controlled.pdf
    Source Binding

    reviewed

  • Id

    metrology-certification-for-measuring-devices

    Name

    Metrology certification for measuring devices

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Device With Measuring Function

    Note

    GL-034 §8.4: medical devices with a measuring function require certification on medical devices, metrology or equivalent.

    Source Binding

    unresolved

  • Id

    aea-radiation-approval-certificate

    Name

    AEA radiation approval certificate

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Emitting Device

    Note

    GL-034 §8.4: radiation-emitting medical devices require an Atomic Energy Authority (Sri Lanka) approval certificate; the requirement is repeated in the 30 June 2023 notice.

    Source Urls
    • https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6881ba1be938700be5b63a4d_Guidelines%20for%20consoildated%20dossier-%20Version%20controlled.pdf
    • https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&Itemid=185&lang=en
    Source Binding

    candidate

  • Id

    sterile-and-biological-material-evidence

    Name

    Sterile and animal-derived material evidence

    Category

    Product Specific Conformity

    Status

    Included In Medical Registration

    Object

    Sterile Or Animal Material Device

    Note

    GL-034 §8.4: sterile devices require a sterility report, sterilization validation protocol with report, EO residual test data for EO-sterilized products and package-integrity data; devices containing animal-derived materials require a materials list and a BSE report; the legacy 2011 guideline additionally required ITI or government-accredited-laboratory analytical reports for blood-contact devices and SLSI standardization reports for plasters, gauze and surgical gloves.

    Source Binding

    unresolved

Official Sources
  • Authority

    AERC (Atomic Energy Regulatory Council, Sri Lanka)

    Topic

    regulation of sources and practices through licensing and approvals; remit limited to non-power applications

    Url

    https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&catid=37&Itemid=105&lang=en

  • Authority

    AERC (Atomic Energy Regulatory Council, Sri Lanka)

    Topic

    approval required to import or export radioactive sources and X-ray machines

    Url

    https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&Itemid=185&lang=en

  • Authority

    TRCSL (Telecommunications Regulatory Commission of Sri Lanka)

    Topic

    Annual Report 2016 — s 21 vendor licences and Networks Division type approval and clearance letters

    Url

    https://www.trc.gov.lk/content/files/reports/AnnualReport2016E.pdf

  • Authority

    NMRA (Sri Lanka)

    Topic

    GL-034 consolidated dossier guideline §8.4 — electrical/EMC, metrology, AEA radiation, sterility, BSE

    Url

    https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6881ba1be938700be5b63a4d_Guidelines%20for%20consoildated%20dossier-%20Version%20controlled.pdf

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