Explore the IVD requirements currently available for Sri Lanka, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
What local class follows from which rules and decisive product facts?
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.
EU-based risk classes I, IIa, IIb and III for general devices and A-D for IVDs (NMRA GL-037).
i
Class I
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
NMRA
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
Regulatory reference
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.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
sri-lanka
All device classes (general medical devices and IVDs)
No Reliance Route
none
Product Marketing
Yes
Yes
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-lanka:medical-device
sri-lanka
EU-based risk classes I, IIa, IIb and III for general devices and A-D for IVDs (NMRA GL-037).
i
Class I
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
NMRA
official-source-verified
NMRA Guideline GL-037 — Registration of Low Risk Products, Sections 3-6
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a04140e14d44d1d153f4124_New%20Guideline%20for%20low%20risk%20product%20registration.pdf
2026-08-25
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
No maintained record.
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
sri-lanka
Sri Lanka
LK
NMRA
250
250
USD
Yes
1000
1000
USD
Yes
new-application-foreign
New application processing fee - foreign applicant
USD
1000
USD 1,000
Per application
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
new-application-local
New application processing fee - local applicant
USD
750
250
750
USD 250–750
Per application
Local Category A USD 750; Local Category B USD 250.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
registration-renewal
Registration renewal after five years
USD
750
200
750
USD 200–750
Every 5 years
Foreign USD 750; Local Category A USD 500; Local Category B USD 200.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
registration-certificate-five-year
Certificate of registration valid for five years
USD
400
100
400
USD 100–400
Per certificate
Foreign USD 400; Local Category A USD 200; Local Category B USD 100. A LKR 2,000 stamp duty applies to each certificate.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
provisional-registration-certificate
Provisional registration certificate (maximum two years)
USD
200
50
200
USD 50–200
Per certificate
Foreign USD 200; Local Category A USD 100; Local Category B USD 50.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
additional-data-evaluation
Additional data evaluation
USD
500
100
500
USD 100–500
Per evaluation
Foreign USD 500; Local Category A USD 200; Local Category B USD 100.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
variation-review
Variation that requires review
USD
200
USD 200
Per variation
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
manufacturing-plant-approval-foreign
Foreign manufacturing plant approval processing fee
USD
1500
USD 1,500
Per plant
Additional data for plant evaluation: USD 300.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
gmp-inspection-foreign
Foreign GMP inspection
USD
20000
15000
20000
USD 15,000–20,000
Per inspection
SAARC countries USD 15,000; other countries USD 20,000. Air tickets, visa fees, and in-country transport are borne by the applicant.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
gmp-inspection-local
Local GMP inspection
USD
300
100
300
USD 100–300
Per inspection
Manufacturing site Category A USD 300, Category B USD 100; packaging/repackaging site USD 100.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
sample-import-licence
Sample import licence
USD
100
USD 100
Per licence
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
import-licence
Import licence
USD
100
USD 100
Per licence
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
free-sale-certificate
Free-sale certificate
USD
50
USD 50
Per certificate
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
who-gmp-certificate
WHO GMP certificate
USD
100
USD 100
Per certificate
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
clinical-trial-processing
Clinical trial processing fee
USD
1000
0
1000
USD 0–1,000
Per trial
Industry sponsored USD 1,000; academic with international sponsorship USD 250; local investigator sponsored free of charge.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
agency-transfer
Agency transfer
USD
1000
USD 1,000
Per party
Charged per manufacturer and per new marketing-authorisation holder.
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
advertisement-processing
Advertisement processing fee (all categories)
USD
1000
USD 1,000
Per advertisement
exact-current
official-verified
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
2026-08-01
2026-08-25
2026-08-25
official-verified
NMRA monthly fee schedule for medical devices, effective 01/08/2026-31/08/2026 (sections I-XI)
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6a7af6729c22b49105f3579d_e8a_Device%20-%2003.08.26.pdf
2026-08-01
2026-08-25
NMRA medical devices page, Fees section
https://www.nmra.gov.lk/pages/medical-devices
2026-08-25
2026-08-25
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.
sri-lanka
Sri Lanka
low
aerc-licence-to-use-ionizing-radiation
Atomic Energy Regulatory Council licence to use ionizing radiation
Ionizing Radiation
Mandatory For Use Site
Radiation Practice Operator
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.
candidate
aerc-facility-plan-approval
Council approval of the facility plan
Ionizing Radiation
Mandatory For Use Site
Radiation Facility
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.
reviewed
aerc-import-approval-covers-x-ray-machines
Council import approval extending to X-ray machines
Ionizing Radiation
Mandatory At Import
Importer Of Irradiating Apparatus
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.
reviewed
trcsl-vendor-licence-to-deal-in-equipment
TRCSL vendor licence to deal in telecommunication or radio equipment
Telecom Network Attachment
Mandatory Pre Market
Local Vendor Importer Or Dealer
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.
reviewed
trcsl-type-approval-and-clearance-letter
TRCSL type approval and customs clearance letter
Radio Spectrum
Mandatory At Import
Radio Or Network Equipment
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.
candidate
nmra-dossier-electrical-emc-software-evidence
NMRA dossier electrical, EMC and software evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
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.
reviewed
metrology-certification-for-measuring-devices
Metrology certification for measuring devices
Legal Metrology
Mandatory If Feature
Device With Measuring Function
GL-034 §8.4: medical devices with a measuring function require certification on medical devices, metrology or equivalent.
unresolved
aea-radiation-approval-certificate
AEA radiation approval certificate
Ionizing Radiation
Mandatory If Feature
Radiation Emitting Device
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.
candidate
sterile-and-biological-material-evidence
Sterile and animal-derived material evidence
Product Specific Conformity
Included In Medical Registration
Sterile Or Animal Material Device
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.
unresolved
AERC (Atomic Energy Regulatory Council, Sri Lanka)
regulation of sources and practices through licensing and approvals; remit limited to non-power applications
https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&catid=37&Itemid=105&lang=en
AERC (Atomic Energy Regulatory Council, Sri Lanka)
approval required to import or export radioactive sources and X-ray machines
https://www.aerc.gov.lk/Home/index.php?option=com_content&view=article&id=29&Itemid=185&lang=en
TRCSL (Telecommunications Regulatory Commission of Sri Lanka)
Annual Report 2016 — s 21 vendor licences and Networks Division type approval and clearance letters
https://www.trc.gov.lk/content/files/reports/AnnualReport2016E.pdf
NMRA (Sri Lanka)
GL-034 consolidated dossier guideline §8.4 — electrical/EMC, metrology, AEA radiation, sterility, BSE
https://cdn.prod.website-files.com/666d0695ca3ba7fa496a5068/6881ba1be938700be5b63a4d_Guidelines%20for%20consoildated%20dossier-%20Version%20controlled.pdf
