Medical device regulatory affairs
Medical device registration in Sri Lanka
Medical devices intended for the Sri Lankan market are subject to applicable registration and licensing requirements administered by the National Medicines Regulatory Authority (NMRA). RAQ Consultation assists manufacturers and their appointed Sri Lankan applicants with identifying the relevant route, reviewing documentation and coordinating registration-related work.
At a glance
- Who applies: Overseas manufacturers submit applications through a Sri Lankan Marketing Authorization Holder (MAH) or local agent.
- Main route: New applications are submitted as a consolidated dossier: FMSA + PRD, or PRD without FMSA. Eligible low-risk devices and devices registered with a recognised foreign regulator may follow particular arrangements.
- Quality certificate: The NMRA generally expects ISO 13485; ISO 9001:2015 is accepted only in defined cases.
- Local manufacturers: NMRA manufacturing-site approval and the required GMP evidence apply as well as device registration. The NMRA has withdrawn its 2025 GMP inspection waiver notice for listed and Class I devices; see local manufacturing sites.
- Validity: A first registration is provisional, for one or two years as stated on the certificate. Full registration, for five years, follows a satisfactory evaluation.
- After registration: Listed changes need prior NMRA approval, and adverse events are reported within 24 hours, 14 days or 30 days, depending on the event.
Who this service is for
For manufacturers, importers and brand owners
We support overseas manufacturers seeking access to the Sri Lankan market, local businesses acting as applicants or importers, and manufacturers who need to assess whether their products fall within the NMRA's medical-device framework. The starting point is the intended purpose, device description, manufacturer and the available regulatory evidence.
The legal framework and the local applicant
The NMRA regulates medical devices under the National Medicines Regulatory Authority Act No. 5 of 2015. It states that medical devices must be registered with it, and that licences are needed to manufacture, import, repackage, sell or distribute them in Sri Lanka.
Foreign manufacturers apply through a Marketing Authorization Holder (MAH): a local agent in Sri Lanka responsible for registration, licensing, importation, sale and distribution, and the handling of quality failures for the device. RAQ works with appropriately authorised local agents; see MAH and local regulatory support. Formal representation arrangements are assessed separately according to applicable regulatory requirements, and the MAH's legal responsibilities rest with the appointed MAH.
What RAQ can do
How we can help you prepare
RAQ works within an agreed scope, alongside the manufacturer and the appointed Sri Lankan applicant. The NMRA evaluates the application and makes the registration decision.
Regulatory pathway review
Consider the available product information and identify the current application route to investigate.
Document gap assessment
Compare manufacturer and applicant documents against the applicable submission requirements.
Dossier preparation support
Help organise the technical and administrative information for the relevant applicant.
Submission coordination
Support the responsible local party with document control, clarifications and procedural follow-up.
Deficiency responses
Help the applicant prepare clear responses to NMRA questions and requests for missing evidence, within the stated response period.
Post-registration support
Assist with the documentation and coordination involved in relevant amendments, renewals and follow-up questions.
Services are provided within the scope agreed for each engagement. The NMRA decides applications. RAQ cannot guarantee approval or an approval date.
Understand the regulatory route
The registration route depends on the device
There is no single file that fits every device. The NMRA distinguishes general medical devices, in vitro diagnostics and listed devices, with different technical and manufacturing-site requirements. Some products may qualify for a particular low-risk or reliance route. We establish the category first so the dossier is built on the correct basis.
General medical devices
Devices used for medical purposes other than IVD testing. Their intended use, design and risk-related characteristics determine the relevant supporting evidence.
In vitro diagnostic devices
Products intended for the examination of specimens and related diagnostic purposes may require IVD-specific performance and technical documentation.
Listed and eligible low-risk devices
The NMRA publishes a specific route for listed devices and certain Class I general devices and Class A IVDs within its applicable appendix. Eligibility must be established from the current guidance, not inferred from risk class alone.
Detail: definition, product categorisation and risk class
The NMRA's definition covers instruments, apparatus, appliances, software, materials and other articles intended for purposes such as diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, investigation or modification of anatomy, and control of conception. A device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, although such means may assist it. Ayurveda and homeopathy devices are excluded from the definition.
The NMRA's Medical Devices page has a Product Categorization Letters (PCL) section, with an application form (F-MDR-044), checklist (F-MDR-043) and acknowledgement (F-MDR-042), and a list of products that the NMRA considers do not come under the purview of medical devices. RAQ recommends settling a product's status early where it is borderline; see also borderline products.
The NMRA's low-risk guideline (GL-037) states that general medical devices and IVDs are classified following the principles and rules of the classification guidance under the European Union (EU) Medical Device Regulations. It refers to Classes I, IIa, IIb and III for general devices and Classes A to D for IVDs. RAQ recommends recording the classification rule applied and the reasoning, because the class affects the route and the evidence expected.
Detail: how the NMRA's guidelines describe each device group
GL-034 defines general medical devices as products within the medical device definition other than IVDs. The technical evidence expected depends on the device: for example, sterile, active, measuring, radiation-emitting and software devices each have additional items.
IVDs are registered under the same framework. IVDs submitted as consolidated dossiers need a performance evaluation test report (analytical and clinical).
The NMRA describes listed devices as products that do not fall within the statutory definition of a medical device but are used for personal hygiene or general medical purposes. They are registered, but are exempt from foreign manufacturing site registration, and ISO 13485 or ISO 9001:2015 is accepted.
Detail: scope of the low-risk route (GL-037)
The NMRA's low-risk guideline, GL-037 (in effect since 13 May 2026), applies only to products named in its Appendix 1 list: listed devices, and Class I general medical devices and Class A IVDs that are not sterile, not active and have no measuring function. It does not apply to Class IIa, IIb or III general devices or to Class B, C or D IVDs. Being Class I or Class A does not by itself qualify a device, and the NMRA states that the list may be updated.
Eligible devices are exempt from foreign manufacturing site registration and from end-user performance evaluation.
Detail: how a low-risk application is processed
Documents follow checklist F-MDR-046 (GL-037 Appendix 2). As for consolidated dossiers, the local agent completes the online form, the accepting officer checks the documents and issues a payment note, and the dossier is submitted with the yellow receipt and receives a low-risk dossier number. If the documents are satisfactory against the evaluation checklist, the evaluation goes to the Medical Device Evaluation Committee (MDEC); if data is deficient, the NMRA emails the applicant, who has two months from that email to respond with any relevant payment, failing which the application is marked as awaiting data. MDEC decisions go to the NMRA's Chief Executive Officer for approval, and the Licensing Division issues the registration certificate and import licence.
The low-risk checklist does not list a sample import licence application; whether one is needed for a particular product should be confirmed with the NMRA.
Detail: quality certificates on the low-risk route
Checklist F-MDR-046 sets the certificate by device and site. Listed devices: ISO 13485 or ISO 9001:2015 for foreign sites, and ISO 9001:2015 accredited by the Sri Lanka Accreditation Board (SLAB) or an equivalent competent body for local sites. Low-risk Class I and Class A devices: ISO 13485 for foreign sites, and ISO 13485 accredited by SLAB or an equivalent competent body for local sites.
A new local manufacturer may apply with ISO 9001 and must submit an ISO 13485 certificate within two years; the checklist sets the same two-year requirement for local manufacturers already audited by the NMRA.
Consolidated new applications
Current NMRA consolidated dossier procedure
Since 5 August 2025, the NMRA has accepted new medical-device registration applications as consolidated dossiers. The published procedure distinguishes a combined Foreign Manufacturing Site Approval and Product Registration Dossier (FMSA + PRD) from a PRD-only route where the applicable requirements allow. RAQ reviews which route is relevant before the application is assembled.
FMSA + PRD
A consolidated submission that includes the manufacturing-site application and product registration dossier for the relevant devices and manufacturers. The site and product stages remain subject to NMRA evaluation.
PRD without FMSA
A consolidated product registration dossier without a new FMSA where the applicable regulatory provisions or exemption permit this route. Listed devices have particular manufacturing-site treatment under the NMRA's published procedure.
Sample Import Licence
Under the published consolidated procedure, the NMRA may issue the approved form needed to obtain a Sample Import Licence (SIL). Where applicable, the applicant completes the licensing steps and supplies the SIL copy and request to initiate evaluation in the manner required by the NMRA.
The precise sequence and eligibility should be confirmed against the current NMRA consolidated dossier guideline and applicable checklist.
- Online form and checkComplete the NMRA's online form. The accepting officer checks the dossier against checklist F-MDR-035 and issues a payment note.
- Payment and dossier numberPay through the Accounts Division; the dossier is submitted with the yellow receipt and receives a reference number.
- Site decision and sample import licenceWhere an FMSA is included, the NMRA emails its decision. The sample import licence is then obtained from the Licensing Division.
- EvaluationA copy of the licence and a request letter start the evaluation. Missing data or samples are due within two months of the NMRA's email.
- RegistrationApproved applications go to the Licensing Division, which issues the registration certificate and import licence.
Low-risk devices named in GL-037 Appendix 1 follow a shorter checklist. The NMRA decides each application; RAQ cannot guarantee approval or an approval date.
Detail: which devices use each dossier type, submission and payment (GL-034)
The NMRA's guideline GL-034 (effective 23 July 2025) describes FMSA + PRD for general medical devices and IVDs, and PRD without FMSA for general medical devices, IVDs and listed devices, for both foreign and local manufacturers. Listed devices are exempt from manufacturing site registration for foreign manufacturers. The NMRA's checklist asks for a copy of an existing NMRA foreign site approval or NMRA product registration certificate as evidence, where applicable, and distinguishes reliance and non-reliance applications.
The accepting officer checks that the documents in the checklist are present (the content is evaluated later) and issues a payment note. The applicant pays through the NMRA's Accounts Division and returns the dossier with the yellow payment receipt; the accepting officer verifies the receipt, assigns a dossier reference number and issues an acknowledgement. The NMRA states that incomplete submissions are not accepted for evaluation. It publishes a monthly fee schedule for medical devices, and the payment depends on the type of application.
For FMSA + PRD, once the FMSA is approved, the NMRA's Medical Device Regulatory Division emails a scanned copy of the approval, the approved sample import licence form where applicable, and the payment note for the PRD. The applicant pays for the PRD and submits the yellow receipt to the accepting point. If the FMSA is rejected or data is awaited, the NMRA shares an evaluation sheet without a payment note. For PRD without FMSA, the Division emails the approved sample import licence form, if applicable.
Detail: the Sample Import Licence sequence
On the consolidated route, the sample import licence application (Schedule IV, Form C) is part of the PRD. The NMRA's guideline sets the sequence:
- The NMRA emails the applicant the approved Form C and evaluation sheet: after FMSA approval for FMSA + PRD, or, where applicable, for PRD without FMSA.
- The applicant submits a scanned copy of the approved form to the NMRA's Licensing Division, pays the SIL fee there and receives the licence.
- The applicant submits a copy of the SIL with a request letter to the accepting point to start the evaluation, and receives an acknowledgement.
The applicant also declares in the dossier that samples will be submitted if the NMRA requests them. The NMRA published notices on submitting a copy of the issued SIL for medical devices (July 2026) and on reissuing SILs for medical devices (May 2026); both are scanned documents and should be read in full, see official references.
Detail: how the dossier must be presented
GL-034 asks for the documents in a box file with green tape on its side. The front must show the generic name, brand name, manufacturer name and address, local agent and type of dossier, with space for the dossier number. All pages are numbered, an index with headings and page numbers is pasted inside the file, and the details of the person responsible for regulatory affairs are included. The dossier is divided into general documents, a section for the FMSA (where included) and a section for the PRD.
If the legal manufacturer has appointed more than one local agent, GL-034 asks for a tabulated letter of authorisation giving the details of all local agents, the product range and the manufacturing site.
Detail: foreign manufacturing sites, inspections and quality certificates
The FMSA section of the dossier includes the FMSA application form, the MAH's business and company registration, declarations from the manufacturer and from a regulatory pharmacist or qualified person, a site master file and a list of exporting countries. The full list is in the detailed document checklist.
The NMRA's Medical Devices page also describes site approval as an online application through its eNMRA portal, with a separate application for each site, a desk review including the site master file and, where the documents are satisfactory, a GMP inspection. How this relates to the FMSA in a consolidated dossier should be confirmed for each application.
The NMRA states that it would exempt a site from onsite GMP inspection if the site had been inspected by a stringent regulatory authority or the World Health Organization. Whether this applies is decided by the NMRA. RAQ can help a manufacturer prepare, but does not conduct inspections or issue approvals.
The NMRA generally expects ISO 13485 certification. ISO 9001:2015 is accepted only in defined cases, such as listed devices and certain low-risk local manufacturers. Which certificate is accepted for a particular dossier is confirmed for each application. For consolidated dossiers, checklist F-MDR-035 asks for a certificate issued by a certification body accredited by the International Accreditation Forum (IAF) or by a recognised national accreditation body, together with a detailed ISO audit report.
Documents commonly reviewed
Building a complete and consistent dossier
The contents of a dossier depend on the device and submission route. The following are common areas of review, not a complete checklist for every product.
- Appointment and authorisation documents for the Sri Lankan applicant.
- Identification of the legal manufacturer and physical manufacturing site.
- Relevant business registration and manufacturing-site information.
- Current quality-system certificates and manufacturing compliance evidence.
- Device description, intended use, models, accessories and product identification.
- Applicable foreign registration or market-authorisation evidence.
- Free Sale Certificate or other relevant regulatory evidence as required.
- Labels, instructions for use and product literature.
- Certificates of Analysis, inspection reports or performance evidence as applicable.
- Sterilisation, biological, electrical, software or IVD performance documents where relevant.
- Applicable forms, declarations and submission checklist.
For new consolidated applications, the NMRA revised the document acceptance checklist F-MDR-035 with effect from 7 July 2026. The dossier should be prepared against the current version, not a saved historical checklist.
The NMRA also directs medical-device applicants to complete its published pre-submission Google Form and follow the current physical dossier-acceptance arrangements. Those practical steps can change, so use the latest instructions rather than a date or appointment copied from an older file.
Detailed document checklist: common administrative documents (all dossiers)
- Original letter of authorisation from the legal manufacturer, addressed to the NMRA's Chief Executive Officer and stating the product range.
- Declaration from the local agent confirming the type of dossier.
- Declaration of intention to submit samples on the NMRA's request.
- Agency transfer letter issued by the NMRA, if applicable.
Detailed document checklist: common technical documents
- Valid free sale certificate, with a stated validity or issued within the last three years, issued by the relevant health authority or government body of the country of origin. GL-034 asks for the original or another verification method, such as a QR code or web link.
- Foreign registration evidence: a valid product registration certificate or free sale certificate issued by the relevant health authority.
- ISO quality management system certificate from an accredited certification body, and a detailed ISO audit report.
- Copy of an NMRA foreign site approval or NMRA product registration certificate as evidence, if applicable.
- For local manufacturers: copy of the NMRA GMP report and GMP certificate, if applicable.
- For reliance applications: evidence of reference-authority registration, certified by the Sri Lankan embassy, shown by the valid original free sale certificate, or verifiable online.
Detailed document checklist: FMSA section (where a foreign site needs approval)
- FMSA application form.
- Business registration, Board of Directors' registration (if applicable) and company registration (Form 01/15/40) of the authorised MAH.
- Manufacturer's declaration on local representation, manufacturing site status, readiness for inspection and accuracy of documents.
- Declaration from the regulatory pharmacist or qualified person that the information is correct.
- Legal manufacturer's declaration of its other manufacturing sites not included in the application.
- Local agent's consent to withdraw the application if the NMRA finds a duplication.
- Site master file, and a list of exporting countries.
Detailed document checklist: PRD core documents for every device
- Application forms: Sample Import Licence (Schedule IV, Form C), and Schedule I Forms A and B.
- Device details from the manufacturer.
- Declaration of conformity or the applicable EC/EU quality system certificate; for CE-marked devices, the EC design examination certificate if applicable.
- Summary technical documentation (STED) or IMDRF table of contents, if applicable, and an essential requirements checklist.
- Risk analysis report (for example to ISO 14971).
- Certificate of analysis or finished product test or inspection report, with the non-clinical test parameters and specifications; needle quality reports for devices with needles.
- Product labels (original, artwork or draft), product catalogue or brochure, and a list of standard accessories, reagents and consumables, if applicable.
Detailed document checklist: PRD device-specific documents
- Stability protocol and data report, if applicable.
- Sterile devices: sterility report, sterilisation validation protocol and report, ethylene oxide residue data for EO-sterilised products, and package integrity data.
- Biological evaluation report, and clinical evaluation report, if applicable. The revised checklist's clinical evaluation item refers to data "conducted for minimum 1000 participants for class IIb & III"; how this is applied to a particular device should be confirmed with the NMRA.
- Active devices: electrical safety and electromagnetic compatibility data (for example to IEC standards).
- Devices with a measuring function: metrology or equivalent certification.
- Radiation-emitting devices: an Atomic Energy Authority approval certificate.
- Software verification and validation report, and third-party test reports, if applicable.
- Devices containing biological material: a list of materials from animal, human, microbial or recombinant sources, and a BSE report if applicable.
- IVDs: performance evaluation test report (analytical and clinical).
- Instructions for use, if applicable, and a patient information leaflet in Sinhala, Tamil and English for point-of-care devices.
Reliance and special routes
When other approvals may be relevant
The NMRA's reliance arrangements can take account of qualifying registrations granted by specified foreign regulators. The recognised countries for general medical devices and IVDs are not identical. A foreign approval may be useful evidence, but it is not a Sri Lankan registration certificate and does not guarantee NMRA approval.
The NMRA also publishes separate arrangements for eligible low-risk devices. Eligibility should be checked against the current guideline and appendices before describing a device as suitable for that route; see the low-risk route detail.
Local manufacturers have separate manufacturing-site and GMP requirements; see Manufacturing-site and GMP requirements for locally manufactured medical devices.
Detail: reliance criteria, reference countries and what reliance changes
Since 29 October 2025, the NMRA may consider a new general device or IVD application under its reliance pathway when one of three criteria is met and verified: the product is registered with the authority of the country of manufacture, or of the legal manufacturer's country, and that authority is an NMRA reference authority; or the product is registered with an NMRA reference authority elsewhere.
The reference countries are the USA, UK, Australia, Canada, Japan, Norway, Switzerland and all EU member states; for IVDs, Singapore as well. The applicant tells the accepting officer at submission and provides the supporting evidence.
Reliance waives end-user evaluation only. The dossier is still evaluated, and all other procedures, requirements, fees, labelling and post-market obligations apply. The NMRA may ask for more documents, samples or clarification, and applications that do not qualify follow the standard evaluation. The NMRA states that the overall evaluation period for reliance applications will be shorter than for non-reliance applications. It does not give a time, and RAQ cannot promise one.
Detail: other special arrangements
Devices for aesthetic purposes. In a notice of 28 July 2026, the NMRA set out which product categories it regards as devices for the modification of appearance or anatomy (aesthetic-related purposes). The notice is a scanned document; its registration arrangements should be read in full before planning an application, see official references.
Device-specific instructions. The NMRA also publishes instructions for particular device groups, such as its general instructions for applications for orthopaedic implants and instrument sets. Check the NMRA's regulatory updates for the device concerned before preparing a dossier.
Waiver of registration. The NMRA's Medical Devices page describes a separate waiver of registration (WOR) procedure, with its own application and committee, handled through a ministry office rather than the NMRA dossier route. Whether it is available for a particular case should be confirmed with the authorities.
Local manufacturing
Manufacturing-site and GMP requirements for locally manufactured medical devices
Manufacturers producing medical devices in Sri Lanka must meet the applicable NMRA requirements for manufacturing-site approval and Good Manufacturing Practice (GMP).
The process may involve review of the facility layout, Site Master File, manufacturing operations, quality-control arrangements and supporting documentation, together with NMRA inspections and GMP assessments where required. The NMRA's Manufacturing Sites page describes site approval as involving the Site Master File and GMP audits.
For locally manufactured medical devices, applicants must provide the relevant manufacturing-site approval and GMP evidence required under the applicable NMRA procedure. The NMRA's Medical Devices page lists, for local manufacturers, a copy of the GMP report issued by the NMRA where applicable, together with the quality-system certificate the route requires (ISO 13485, or ISO 9001:2015 in the specified cases for listed devices).
Manufacturing-site approval does not automatically register individual medical devices. The applicable product registration and manufacturing licensing requirements must also be satisfied.
What the local process can involve
- A manufacturing-site application with a Site Master File
- Assessment of the facility layout and technical documents
- NMRA GMP inspection or audit, where the procedure requires it
- Manufacturing-site approval and the NMRA GMP report or other required evidence
- Registration of each device under the applicable route
- The applicable manufacturing licences
These are related but separate requirements. Their order and the forms used should be taken from the NMRA's instructions for the specific application. An ISO certificate does not by itself replace NMRA manufacturing-site approval or a required GMP inspection.
GMP inspection exemptions: current position
In 2025 the NMRA published a notice titled "GMP Inspection Waiver for Listed and Class 1 Medical Devices". It later published a notice withdrawing that web notice of 8 May 2025 (NMRA withdrawal notice (opens in a new tab) ↗). Although the original notice is still accessible, we have found no replacement or reinstatement, so it should not be relied on.
Separately, the NMRA's low-risk device guideline GL-037 (effective 13 May 2026) states that the low-risk devices in its Appendix 1 are exempt from GMP inspections for local manufacturers. Listed or Class I status alone does not establish that a device qualifies: any exemption must be confirmed for the specific device under the currently applicable NMRA requirements.
RAQ Consultation assists local manufacturers with regulatory planning, Site Master File preparation, GMP gap assessments, SOPs, quality-system documentation, inspection readiness and coordination of manufacturing-site and product-related submissions. See Quality systems and GMP consulting.
Evaluation and follow-up
Registration does not end at dossier submission
Acceptance is only the start of evaluation. The NMRA may request clarification, missing evidence or samples. Under the published consolidated procedure, a two-month stop-clock period applies to the requested deficiency response and associated payment, counted from the notification email. Applicants must follow the instructions for the specific file.
Registration also creates continuing work. The MAH must consider relevant licences, renewals, approved changes and vigilance obligations. Changes to a registered device or its manufacturing information may require NMRA review before implementation.
Detail: how the NMRA evaluates applications
The NMRA's Medical Device Evaluation Committee (MDEC) carries out the technical evaluation of devices for registration, considering quality, safety, effectiveness, need and cost. End-user evaluation forms part of the standard evaluation; the NMRA waives it for reliance applications and for low-risk devices within GL-037.
The NMRA states that failure to submit requested data or samples within the two months may result in delays or rejection of the application. RAQ recommends answering each point fully in one response and tracking the deadline from the date of the email.
The NMRA guidance reviewed does not set a fixed evaluation period. Timing depends on the pathway, the completeness of the dossier, any further information requests and the NMRA's evaluation. The NMRA's Medical Devices page does not describe an appeal procedure for device decisions. RAQ cannot guarantee approval or an approval date.
After registration: the MAH's continuing obligations
An approved application leads to a registration certificate and an import licence, issued by the NMRA's Licensing Division.
Validity
A first-time registration is provisional, for one or two years as stated on the certificate. Full registration is issued after a satisfactory evaluation and is valid for five years.
Renewal
The NMRA states that renewal applications “should be made before six months from the date of expiry”. It allows two months to provide any additional information it requests during renewal, and publishes a re-registration dossier checklist.
Changes to a registered device
The NMRA states that changes to the product name, specifications, packaging, indications, label, package insert or product literature must not be made without prior NMRA approval; registration may be cancelled otherwise. Changes affecting quality, safety or efficacy require a new application.
Continuing MAH responsibilities
The NMRA treats the applicant or MAH as fully responsible for the product and its data, which must be accurate, complete and authentic. The MAH must promptly inform the NMRA of relevant changes, including product information, the manufacturing process, safety, quality or effectiveness data, cGMP compliance, and the device's regulatory status in other countries, such as a rejection or withdrawal. Advertising or promoting a medical device needs the NMRA's prior written approval.
Import and manufacturing data
The NMRA's import-data instructions (opens in a new tab) and manufacturing-data notice (opens in a new tab) include medical devices. Applicable importers and local manufacturers must submit import or manufacturing data in the format prescribed by the NMRA, including the relevant quarterly reporting periods.
Adverse-event reporting
The NMRA sets the following reporting timelines, counted from when the reporter becomes aware of the event. It provides three reporting forms: F-MDR-036 (importers/suppliers), F-MDR-037 (manufacturers) and F-MDR-038 (consumers and healthcare facilities, also available online).
Completed forms are sent by email to the address the NMRA gives, or by post to its Chief Executive Officer. RAQ's involvement in vigilance depends on the agreed scope.
| Event | Report within |
|---|---|
| Death or serious deterioration in health that occurred | 24 hours |
| Death or serious deterioration in health that might have occurred | 14 days |
| Other events | 30 days |
Detail: certificate and licence amendments
Amendments to registration certificates and licences follow a separate NMRA procedure from variation approval, set out in an NMRA notice to MAHs (opens in a new tab). The NMRA processes an amendment only if both the registration certificate and the relevant import or manufacturing licence have at least three months' validity left, and the payment is due within three weeks of the NMRA's payment confirmation email. If the licence has less than three months left, the changes are submitted with the licence renewal instead; a payment made for an amendment that cannot be processed for this reason is not refunded.
Common difficulties
Problems worth identifying early
Manufacturer and product information do not match
Company names, addresses, product models and manufacturing sites should be consistent across authorisations, certificates and technical files.
The wrong route or checklist is used
The submission pathway, device category and current checklist must be checked before finalising the dossier.
Supporting evidence is incomplete
Technical reports, quality certificates, labels or declarations may need to be updated or supplemented.
Responsibilities are unclear
The legal manufacturer, local MAH and importer need to understand their respective roles before submitting information.
Further examples we check
- Certificates have expired or do not cover the proposed product range.
- Technical testing does not match the device's intended purpose or applicable standards.
- Authorisation letters omit the correct parties or product scope.
FAQs
Frequently asked questions
Does a foreign manufacturer need a Sri Lankan local agent?
The NMRA states that overseas medical-device manufacturers submit applications through a Sri Lankan Marketing Authorization Holder or local agent. The precise appointment and documentation requirements should be reviewed for the product.
Is ISO 9001 enough for every medical device?
No. The NMRA's consolidated dossier requirements distinguish the quality-system documentation expected for listed and non-listed devices. The applicable ISO 13485 or, in specified circumstances such as listed devices, ISO 9001 evidence should be checked before submission.
Can foreign registration replace NMRA registration?
No. Foreign approvals may be relevant to an eligible reliance route, but Sri Lankan authorisation remains subject to the NMRA's requirements and decision.
Does every Class I device use the low-risk procedure?
No. The NMRA's low-risk procedure is tied to published eligibility criteria and product appendices. Classification alone is not enough to establish eligibility.
Are listed or Class I devices exempt from NMRA GMP inspection?
Not automatically. The NMRA has withdrawn its 2025 web notice on a GMP inspection waiver for listed and Class I devices. Its current low-risk guideline (GL-037) exempts local manufacturers of the devices in its Appendix 1 from GMP inspections; whether a device qualifies must be confirmed for that device. See local manufacturing sites and GMP.
Does an ISO 13485 certificate replace NMRA manufacturing-site approval?
No. An ISO certificate is evidence of a quality system, issued by a certification body. Local manufacturers must still meet the NMRA's manufacturing-site approval and GMP requirements, and each device still needs registration.
Can RAQ guarantee approval or a fixed timeline?
No. The NMRA controls its evaluation and decisions. RAQ can assess readiness and coordinate work, but cannot guarantee an approval or statutory processing period.
Official NMRA references
- NMRA: Medical Devices (guidelines, forms and fees) (opens in a new tab) ↗
- NMRA: Consolidated dossiers for new device applications (opens in a new tab) ↗
- NMRA: Consolidated dossier guideline GL-034 (PDF) (opens in a new tab) ↗
- NMRA: Revised checklist F-MDR-035 (opens in a new tab) ↗
- NMRA: Low-risk device guideline GL-037 (PDF) (opens in a new tab) ↗
- NMRA: Reliance pathway for new device applications (opens in a new tab) ↗
- NMRA: Submission of a copy of the issued SIL, medical devices (PDF) (opens in a new tab) ↗
- NMRA: Reissuance of SILs, medical devices (PDF) (opens in a new tab) ↗
- NMRA: Devices for modification of appearance or anatomy (PDF) (opens in a new tab) ↗
- NMRA: Instructions for orthopaedic implants and instrument sets (PDF) (opens in a new tab) ↗
- NMRA: Manufacturing sites (opens in a new tab) ↗
- NMRA: Withdrawal of the 8 May 2025 GMP inspection waiver notice (listed and Class I devices) (opens in a new tab) ↗
- NMRA: Announcements (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.
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