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Lithuania medical device registration resources

Research VASPVT registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Lithuania medical device resource.

5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Additional certification and licence checker

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

Medical device regulation news

Follow recent State Health Care Accreditation Agency (VASPVT) policy, guidance, safety, and compliance updates.

Government registration fees

Check the Lithuanian state duties (valstybės rinkliava) payable to VASPVT for device registration, certificates, and study authorisations.

Registration timeline

Compare official and realistic VVKT approval times by device class and pathway.

AI medical device classifier

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Structured regulatory requirements

Explore all 41 source-linked facts →

23 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Authority role towards notified bodies
VASPVT designates testing laboratories and certification/control bodies wishing to become notified bodies for medical device conformity assessment, supervises them, extends/renews their sco…
Authority registration and certificate functions
VASPVT registers medical devices placed on the market, issues permits entitling persons to perform technical condition inspection of medical devices, and issues free sale certificates.
3 source-linked facts
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
Amendment chain with effective dates
The device chapter of HSL I 552 was amended by Law XIII 2947 (effective 2021 05 26, TAR 2020 11067), Law XIV 1059 (effective 2022 05 26, TAR 2022 09668), Law XIV 2745 (effective 2024 06 21,…
EUDAMED-dependent effectiveness
Law XIII 2947 Art. 14(2): the EUDAMED era provisions of the amendment package (Arts. 5 and 10 of Law XIII 2754, i.e. the EUDAMED based registration/notification and duties regime) enter int…
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Definitions aligned to MDR
Article 2 of the Health System Law defines device terms by direct reference to Regulation (EU) 2017/745 (e.g. 'incident', 'notified body'), so the MDR/IVDR definitions govern nationally wit…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-26
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D05

Registration pathways

Verified
14-working-day data submission for Class IIA/IIB/III
Manufacturers, authorised representatives, importers and distributors placing on the Lithuanian market devices classified under Regulation (EU) 2017/745 as Class IIA, IIB or III, or custom…
Market-access route or official registration surface
submissionSurface: National registration/notification with VASPVT under HSL Art. 59 1: document submission for the registered categories (custom made, IVD, performance evaluation, Class I,…
4 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity
target: geo:ltu · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Lithuania-established authorised representative
Where a device manufacturer has no establishment in an EEA member state, the data required by HSL Art. 59 1(3) must be submitted by the manufacturer's authorised representative established…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Ban on supplying devices outside trade premises
It is prohibited to place medical devices on the market outside trade premises and/or to distribute them to consumers; the ban does not apply to distance contract sales, vending machine dis…
1 source-linked fact
Checked 2026-08-25
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D09

Dossier requirements

Verified
Conformity documents in Lithuanian on request
On request of VASPVT (performing state supervision of medical devices), the manufacturer (or authorised representative, assembler/steriliser of systems and packs) must submit, in the Lithua…
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
In-use device data forms (email, Word/Excel)
Healthcare institutions submit in use medical device data to VASPVT (Akreditavimo tarnyba) by email in MS Word (DOC, DOCX) or MS Excel (XLS, XLSX) format, using the forms annexed to the Ord…
Statutory submission channels
Registration documents are submitted to the minister empowered institution (VASPVT) remotely, by electronic means through the contact centre, or by applying directly; the manner of submissi…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Field safety notices in Lithuanian
Manufacturers (or their authorised representatives) must provide users and consumers with field safety notices prepared in the Lithuanian state language, in the manner established by Regula…
Lithuanian-language information rule (English carve-out)
Information on the proper use and maintenance of a device, referred to in Regulation (EU) 2017/745 or 2017/746, must be attached in the Lithuanian state language, or in English where the in…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Manufacturer quality management system (Art. 10(9))
Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…
1 source-linked fact
Checked 2026-08-29
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D13

Standards, testing & ancillary approvals

Unresolved
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
RRT radio equipment technical regulation
Wireless / radio
7 maintained overlays · 2 related facts
Checked 2026-08-25
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D14

Fees

Verified
Registration of a device placed on the Lithuanian market
EUR 38
Registration of changed data about a device already placed on the market
EUR 18
8 maintained fee lines
Checked 2026-08-25
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Free-sale certificate validity
A free sale certificate is valid for as long as the documents proving the device's conformity with Regulation (EU) 2017/745 or the IVD rules are valid, or is valid indefinitely if the valid…
Registration cancellation grounds
VASPVT cancels the validity of a device registration where: the registered person requests it; the registered legal person is liquidated or the natural person deceased; or other grounds lis…
4 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Notification of changed data and market discontinuation
Manufacturers (or authorised representatives, system/pack assemblers sterilisers) must inform VASPVT of changes to the data registered under HSL Art. 59 1(3) and of discontinuation of placi…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
VASPVT data submission to EUDAMED
VASPVT submits data to the European medical devices database EUDAMED under Regulation (EU) 2017/745 and the IVD regulation.
Cessation-of-use data within 60 days
Healthcare institutions must submit data on discontinuation of use of non implantable and IVD devices to VASPVT, using the prescribed form, no later than 60 calendar days from the day of di…
3 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical investigation permits issued by VASPVT
VASPVT issues permits to conduct clinical investigations with a medical device and permits for substantial modifications of a clinical investigation with a medical device.
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Ministerial exceptional-use derogation
The Minister of Health may, in exceptional cases where no equivalent or alternative devices conforming to Regulation (EU) 2017/745 (or the IVD rules) are available, permit devices to be pla…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
Adverse-event reporting during clinical investigations
Sponsors responsible for organising and implementing clinical investigations must report adverse events occurring during clinical investigations in the procedure established by Regulation (…
Incident reporting duty
Manufacturers (or authorised representatives, system/pack assemblers sterilisers) must report incidents in the procedure established by Regulation (EU) 2017/745 or the IVD regulation, or se…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Immediate recall duties for non-conforming devices
On learning that devices do not meet the requirements of Regulation (EU) 2017/745 or 2017/746, the responsible economic operator must immediately stop placing them on the market, recall and…
1 source-linked fact
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Misleading claims prohibition (Art. 7)
In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other…
1 source-linked fact
Checked 2026-08-29
Open details →
D25

Submission communications & appeal

Verified
Appeal route against VASPVT decisions
Medical device market subjects have the right to appeal decisions of the institution empowered by the Minister of Health (VASPVT) under the procedure established by the Law on Administrativ…
30-day deficiency remedy window
VASPVT refuses registration where the submitted documents are incomplete (or improperly formalised, or the device non conforming) and the person fails to remedy the indicated deficiencies w…
2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (8 lines) →

VASPVT registration fees in EUR · reviewed 2026-08-25

Fee lineAmountProvenance
Registration of a device placed on the Lithuanian marketEUR 38Verified
Registration of changed data about a device already placed on the marketEUR 18Verified
Certificate authorising a person to perform device technical-condition inspectionsEUR 145Verified
Free-sale certificate for medical devicesEUR 32Verified
4 more fee lines on the full schedule · 8 of 8 rows source-verified

Registration timeline

Full registration timeline →

State Health Care Accreditation Service under the Ministry of Health (VASPVT) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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