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ZVA · structured requirements

🇱🇻 Latvia IVD regulatory data

Explore the IVD requirements currently available for Latvia, organized by topic and linked to official sources.

13 facts11 dimensions5 official sourceslatest verification 2026-09-16

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Latvia. Each question separates published rules from details still awaiting verification.

Approval validity & renewal

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

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LATMED registration is maintained by an annual vigilance-fee payment

validity.latmed-listing-maintained-by-annual-payment
Fact-level verified
Statement

The agency examines the applications of manufacturers, packers and distributors and enters the information in the LATMED database within 10 days of receipt. If the persons registered under paragraphs 4, 28 and 29 do not cover the agency's costs for the vigilance system within the deadline set by the agency, the agency removes the information about that person from the LATMED database.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Local Application Required

No

Target Decision Retained

Yes

Conditions
  • The annual fee amounts are EUR 105.20 and EUR 201.90 (source res-lv-mk895, Annex rows 62.1 and 62.2).

Effective from 2023-08-23

Latvian source; translation: '31. The agency shall examine the applications referred to in paragraphs 28 and 29 of these Regulations and shall enter the relevant information in the LATMED database within 10 days after receipt thereof. If the persons referred to in paragraphs 4, 28 and 29 of these Regulations do not cover the costs referred to in paragraph 30 within the deadline set by the agency, the agency shall remove the relevant information about the particular person from the LATMED database.'

Authority & regime

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

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State Agency of Medicines (Zāļu valsts aģentūra) is the medical device competent authority

authority.medical-devices-competent-authority
Fact-level verified
Statement

The medical device competent authority in Latvia is the State Agency of Medicines (Zāļu valsts aģentūra, ZVA). Its device functions are to register medical devices manufactured in Latvia, to issue authorisations for placing specially supplied medical devices on the market, to carry out medical device vigilance, and to issue authorisations for clinical investigations of medical devices. The agency maintains the LATMED device register and runs the notification procedure.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Local Application Required

No

Target Decision Retained

Yes

Conditions
  • Market surveillance and control of devices in use is carried out by the Health Inspectorate (Veselības inspekcija), not by the agency (MK noteikumi Nr. 461 paragraph 19.1).
  • The agency is a state institution under the supervision of the Minister of Health, supervised through the Ministry of Health (MK noteikumi Nr. 537 paragraph 1).

Latvian source; translation: '4.7. registers medical devices manufactured in Latvia, issues authorisations for placing specially supplied medical devices on the market, and carries out medical device vigilance; 4.8. issues authorisations for the performance of clinical investigations of medical devices.' The registry label 'ZVA' is an abbreviation; the full legal name is Zāļu valsts aģentūra (State Agency of Medicines).

Clinical investigation & performance

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

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The agency issues authorisations for medical device clinical investigations

clinical.agency-authorises-clinical-investigations
Fact-level verified
Statement

The State Agency of Medicines issues authorisations for the performance of clinical investigations of medical devices; this is one of the device tasks assigned to the agency by its statute, alongside issuing authorisations for placing specially supplied medical devices on the market and carrying out medical device vigilance.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The substantive procedure for clinical investigations of devices intended for humans and performance studies of IVDs is set by the Cabinet under Article 34(2)(1) of the Medical Treatment Law (source res-lv-arstniecibas-likums).
  • Sponsors must insure their and the researcher's civil liability for harm to participants' health or life for the whole study period, under a separate contract concluded before the study begins (Article 34(4)-(6)).

Latvian source; translation: '4.8. issues authorisations for the performance of clinical investigations of medical devices;' The documentation examination fee for a clinical investigation or performance study is EUR 1500.00 and for substantial changes EUR 900.00 (source res-lv-mk895, Annex rows 55-57).

Fees

What regulator fee applies to this class, route, event, and date?

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ZVA device fees: annual vigilance fee, free-sale certificate, non-CE device assessment

fees.agency-device-fee-schedule
Fact-level verified
Statement

The State Agency of Medicines fee schedule (Cabinet Regulation No. 895 of 18 December 2024, in force 1 January 2025) fixes an annual medical device vigilance-system fee of EUR 105.20 for class I devices and other (remaining) and class A IVDs, and EUR 201.90 for class IIa, IIb and III devices, A-list, B-list and self-test, class B, C and D IVDs - payable per manufacturer, authorised representative or distributor. Issuing a medical device free-sale certificate costs EUR 185.41, and the examination of an application and documentation to place on the market individual devices that have not undergone conformity assessment and are not CE-marked costs EUR 528.60.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Local Application Required

No

Target Decision Retained

No

Conditions
  • If an undertaking distributes low-risk and medium- or high-risk devices together, only the single annual payment of EUR 201.90 is due, and the annual fee is fixed regardless of the range of devices, turnover or number of manufacturers.
  • The fees in the schedule are exclusive of VAT, which is not applied under section 3 of the Value Added Tax Law.
  • Fee amounts are due for re-verification after 12 months under the registry review policy.

Effective from 2025-01-01

Latvian source; the four rows are quoted from the Annex (pielikums) to Cabinet Regulation No. 895, whitespace-flattened from the original table. Row 54 = free-sale certificate; row 62 = annual medical device vigilance-system fee (62.1 low risk, 62.2 medium/high risk); row 63 = examination of an application and documentation for devices without conformity assessment and without CE marking.

Label, IFU & language

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

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IVD information for users and patients must be in Latvian

label.state-language-required-for-ivd-information
Fact-level verified
Statement

Information for users and patients under Annex I section 20 of Regulation (EU) 2017/746 must be provided in the Latvian state language. It and other IVD documentation may be in another language only where the IVD is intended for use solely in a healthcare institution by correspondingly qualified and trained healthcare persons, with that institution's consent.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Local Application Required

No

Target Decision Retained

Yes

Conditions
  • The Health Inspectorate may require the conformity information and documentation in the state language or another language of its choice, with a 30-day deadline for technical documentation translations.

Effective from 2023-10-13

Latvian source; translation: '6. The information for users and patients set out in section 20 of Annex I to Regulation No. 2017/746 shall be provided in the state language. The information set out in section 20 of Annex I to Regulation No. 2017/746 and other documentation of the in vitro diagnostic medical device may be not in the state language if the in vitro diagnostic medical device is intended for use only in a healthcare institution and will be used only by correspondingly qualified and trained healthcare persons, provided that the consent of the particular healthcare institution to the use of the particular language in the documentation has been received.'

Official forms & portals

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

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LATMED is the Latvian medical device register, maintained by the agency

portal.latmed-database-maintained-by-agency
Fact-level verified
Statement

The State Agency of Medicines maintains the LATMED electronic database, the medical device register, and is the controller of the LATMED state information system. LATMED holds information on manufacturers of class I devices and procedure packers established in Latvia, on notified medical devices and their manufacturers and distributors, on authorised representatives of manufacturers with no establishment in any EU or EEA state, and on incidents connected with the use of medical devices.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Local Application Required

No

Target Decision Retained

No

Conditions
  • The notification form for medical devices is Annex 1 to Cabinet Regulation No. 461 (source res-lv-mk461); the IVD notification form is Annex 1 to Cabinet Regulation No. 582.

Effective from 2023-08-23

Latvian source; translation: '20. The agency shall maintain the LATMED database. The agency is the controller of the LATMED state information system within the meaning of the State Information Systems Law. The LATMED database shall store the following information: 20.1. information about manufacturers of class I medical devices and device packers referred to in Article 22(1) of Regulation No. 2017/745 whose place of business is registered in the Republic of Latvia; 20.2. information about notified medical devices, their manufacturers and distributors; 20.3. information about authorised representatives of manufacturers of medical devices which have no registered place of business in any EU or EEA Member State; 20.4. information about incidents connected with the use of medical devices;'

Registration pathways

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

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IVD notification procedure covers class B, C, D, A-list, B-list and self-test IVDs

pathway.ivd-notification-procedure
Fact-level verified
Statement

For in vitro diagnostic medical devices, the Latvian notification procedure applies to class B, C and D devices as well as to A-list, B-list and self-test IVDs: the notifier files the notification form (Annex 1 to Cabinet Regulation No. 582) with the State Agency of Medicines and attaches a copy of the EU declaration of conformity and copies of valid notified-body certificates.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Local Application Required

Yes

Target Decision Retained

No

Conditions
  • After the agency publishes the notified data, the notification procedure is deemed complete and the device may be placed on the Latvian market without an agency decision (paragraph 10 and 11 of the regulation).

Effective from 2023-10-13

Latvian source; translation: '8. Persons who in the territory of the Republic of Latvia start placing on the market class B, C and D, as well as A-list, B-list and self-test in vitro diagnostic medical devices, shall submit to the agency a completed notification form (Annex 1) and attach a copy of the EC (EU) declaration of conformity, as well as copies of valid certificates issued by notified bodies (hereinafter - the notification procedure).'

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.

Latvia 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 Latvia (2 records)

LatviaEU conformity assessment

Prior approval / evidence record

CE marking under the Union regulations is the domestic route; no separate Latvian approval decision

reliance.eu-ce-marking-is-the-domestic-route
Fact-level verified
Statement

A CE mark under Regulation (EU) 2017/745 (or 2017/746 for IVDs) is the domestic route into Latvia and is valid throughout the EU/EEA. Once the Latvian notification procedure is complete, the notifier is entitled to place the device on the Latvian market without any decision or approval of the State Agency of Medicines; the agency publishes the notification data and the procedure is then deemed complete. What remains are local obligations: a manufacturer without an EU establishment must designate a sole authorised representative, and a distributor established in Latvia must be entered in the LATMED database before making devices available.

Source Approval

EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

No

Conditions
  • The notification attaches to class IIa, IIb and III medical devices (MK noteikumi Nr. 461 paragraph 9) and to class B, C and D, A-list, B-list and self-test IVDs (MK noteikumi Nr. 582 paragraph 8).
  • The agency checks the submitted declaration of conformity and notified-body certificates against the national regulation, Regulation (EU) 2017/745 and directly applicable EU acts, and may require corrections or translations (MK noteikumi Nr. 461 paragraphs 10 and 16).
  • Manufacturers not established in a Member State may place a device on the Union market only if they designate a sole authorised representative (source res-lv-mdr, Article 11(1)).
  • Distributors established in Latvia may make devices available on the Latvian market only if information about them is entered in the LATMED database (MK noteikumi Nr. 461 paragraph 41.1).
  • Notification may be omitted once the manufacturer complies with MDR Article 29(4) EUDAMED registration, in the window from six to eighteen months after the Commission announces full EUDAMED functionality (MK noteikumi Nr. 461 paragraph 13).

Effective from 2023-08-23

Latvian source; translation: '12. The persons referred to in paragraph 9 of these Regulations, after completion of the notification procedure, are entitled to place the medical device on the market of the Republic of Latvia without a decision or approval of the agency.' The excerpt supports the bounded claim that Latvia issues no separate national approval for a CE-marked device; the EU/EEA-wide validity of the CE mark rests on Regulation (EU) 2017/745 itself (source res-lv-mdr).

LatviaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Medicīnisko ierīču noteikumi (Cabinet Regulation No. 461 of 15.08.2023, in force 23.08.2023; current redaction in force from 01.01.2026) — § 9 the IIa/IIb/III notification, § 11 the ten-working-day publication, §§ 28, 29 and 41.1 the LATMED registration, § 31 the ten-day LATMED entry and §§ 70 and 74.1 the three-day signal reportsZāļu valsts aģentūra — Pirms laišanas apgrozībā: Brīvās tirdzniecības sertifikāta saņemšana — 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.'

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

Review clocks

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

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Agency enters IVD manufacturer, authorised-representative and distributor applications in LATMED within 10 days

clock.ivd-latmed-operator-listing-within-ten-days
Fact-level verified

The agency examines the applications of Latvian-established IVD manufacturers and authorised representatives (paragraph 27) and of IVD distributors (paragraph 28) and enters the information in LATMED within 10 days of receipt; a person that does not cover the agency's paragraph 18 expenses within the set period is removed from LATMED.

Conditions
  • Calendar days; listing is conditional on paying the annual costs under the agency fee schedule.

Effective from 2023-10-13

Latvian source. Translation: 'The agency examines the applications referred to in paragraphs 27 and 28 and, within 10 days of their receipt, enters the relevant information in LATMED. If the persons referred to in paragraphs 4, 27 and 28 do not cover the expenses referred to in paragraph 18 within the period set by the agency, the agency excludes the information on that person from LATMED.'

IVD notification procedure is completed within 10 working days by publication on the agency website

clock.ivd-notification-completed-within-ten-working-days
Fact-level verified

Within 10 working days of receiving the paragraph 8 information, the State Agency of Medicines publishes on its website at least the data received on the in vitro diagnostic device, its manufacturer, authorised representative (if applicable) or notifier and the notification number assigned by the agency; once published, the IVD notification procedure is deemed complete.

Conditions
  • The clock ends with publication, not with an approval decision; the IVD regulation mirrors paragraph 11 of the medical-device regulation No. 461.

Effective from 2023-10-13

Latvian source. Translation: 'Within 10 working days after receipt of the information specified in paragraph 8, the agency ensures public availability on its website of at least the data received within the notification procedure on the in vitro diagnostic medical device, its manufacturer, authorised representative (if applicable) or notifier and the notification number assigned by the agency. After publication of this information on the agency's website the notification procedure is considered complete.'

Submission communications & appeal

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

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Appeal route: review by the Ministry of Health, then the administrative court

appeal.agency-decisions-appealable-to-ministry-and-court
Fact-level verified
Statement

Administrative acts issued by the director of the State Agency of Medicines (other than the decision referred to in paragraph 8 about officials' decisions) and actual action may be contested before the Ministry of Health; the Ministry's decision may then be appealed to the administrative court. Decisions and actual action of officials of the agency's structural units may be contested by submitting an application to the director of the agency, and the director's decision may be appealed to the administrative court.

Source Approval

Target Jurisdiction Id

Edge Type

Market Access Strength

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The procedure and time limits for the contest and appeal follow the Administrative Procedure Law; the statute sets the forum, not the clock.

Latvian source; translation: '8. Decisions and actual action of officials of the structural units of the agency may be contested by submitting a relevant application to the director of the agency. The decision of the director of the agency may be appealed to the administrative court. 9. Administrative acts issued by the director of the agency (except the decision referred to in paragraph 8 of these Regulations) and actual action may be contested in the Ministry of Health. The decision of the Ministry of Health may be appealed to the administrative court.'

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 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.

Open Latvia registration →
Country

Latvia

Jurisdiction Id

latvia

Country Code

LV

Flag

🇱🇻

Regulator

Zāļu valsts aģentūra (State Agency of Medicines)

Regulator Abbrev

ZVA

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Self-declaration (no notified body)

    Official Timeline
    Min

    0

    Max

    0

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    9

    Notes
    • MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
    • Elapsed time is EUDAMED actor and device registration plus the Latvian duties: a class I manufacturer whose place of business is registered in Latvia applies to the agency under § 28 of Cabinet Regulation No. 461 and the agency enters the information in the LATMED database within ten days under § 31
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    latvia-notification-publication

    Class Name

    ZVA publication of a IIa, IIb or III class device notification, which completes the notification procedure

    Risk Level

    high

    Pathway

    National notification under § 9 of Cabinet Regulation No. 461

    Official Timeline
    Min

    10

    Max

    10

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Medicīnisko ierīču noteikumi (Cabinet Regulation No. 461 of 15.08.2023, in force 23.08.2023; current redaction in force from 01.01.2026) — § 9 the IIa/IIb/III notification, § 11 the ten-working-day publication, §§ 28, 29 and 41.1 the LATMED registration, § 31 the ten-day LATMED entry and §§ 70 and 74.1 the three-day signal reports

    Url

    https://likumi.lv/ta/id/344674-medicinisko-iericu-noteikumi

    Effective Date

    2026-01-01

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    10

    Max

    25

    Unit

    working-days

    Notes
    • Verbatim § 11: '10 darbdienu laikā pēc šo noteikumu 9. punktā minētās informācijas saņemšanas aģentūra savā tīmekļvietnē nodrošina publisku pieejamību vismaz paziņošanas procedūras ietvaros saņemtajiem datiem par medicīnisko ierīci, tās ražotāju, pilnvaroto pārstāvi (ja attiecināms) vai paziņotāju un aģentūras piešķirto paziņojuma numuru. Pēc šīs informācijas publiskošanas aģentūras tīmekļvietnē paziņošanas procedūra uzskatāma par pabeigtu.'
    • The duty in § 9 falls on persons who begin to place IIa, IIb and III class devices on the Latvian market and requires the completed notification form (Annex 1) together with a copy of the EU declaration of conformity and copies of the valid notified-body certificates, so one clock spans three classes rather than belonging to any single one
    • The clock stops at publication, not at an approval decision, and the notification does not gate the placing of the device on the market
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    latvia-latmed-registration-entry

    Class Name

    ZVA entry of a manufacturer's or distributor's application into the LATMED database

    Risk Level

    low

    Pathway

    National registration under §§ 28, 29 and 41.1 of Cabinet Regulation No. 461

    Official Timeline
    Min

    10

    Max

    10

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Medicīnisko ierīču noteikumi (Cabinet Regulation No. 461 of 15.08.2023, in force 23.08.2023; current redaction in force from 01.01.2026) — § 9 the IIa/IIb/III notification, § 11 the ten-working-day publication, §§ 28, 29 and 41.1 the LATMED registration, § 31 the ten-day LATMED entry and §§ 70 and 74.1 the three-day signal reports

    Url

    https://likumi.lv/ta/id/344674-medicinisko-iericu-noteikumi

    Effective Date

    2026-01-01

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    10

    Max

    20

    Unit

    days

    Notes
    • Verbatim § 31: 'Aģentūra izskata šo noteikumu 28. un 29. punktā minētos iesniegumus un 10 dienu laikā pēc to saņemšanas ievada attiecīgo informāciju LATMED datubāzē.'
    • The clock is route-wide and not class-specific: § 28 covers the manufacturers of class I devices and the assemblers of systems and procedure packs, and § 29 covers distributors, whichever class they handle
    • The registration is a precondition of distribution rather than of the CE route: § 41.1 provides that distributors may make devices available on the Latvian market only if the information about them as a distributor has been entered in the LATMED database, and § 41.2 extends that to manufacturers, importers and authorised representatives from 1 January 2026
    • The same section fixes a ten-working-day change-report clock (§ 32) and a ten-working-day discontinuation report with a seven-day agency entry (§ 34), which are not separately published here
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    latvia-free-sale-certificate

    Class Name

    ZVA free-sale certificate for a device manufactured in Latvia

    Risk Level

    low

    Pathway

    Paid service of the State Agency of Medicines under its published fee schedule

    Official Timeline
    Min

    30

    Max

    30

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Zāļu valsts aģentūra — Pirms laišanas apgrozībā: Brīvās tirdzniecības sertifikāta saņemšana — 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.'

    Url

    https://www.zva.gov.lv/lv/industrijai/medicinisko-iericu-razotaji-pilnvarotie-parstavji/pirms-laisanas-apgroziba

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    30

    Max

    45

    Unit

    days

    Notes
    • Verbatim from ZVA's page: 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.' The agency issues the certificate in Latvian and English on the application of a manufacturer of a medical device or an in vitro diagnostic medical device, for devices manufactured in Latvia that are marked with the CE marking
    • The period is route-wide and class-independent, and it is published by the agency rather than in the regulation: § 23 of Cabinet Regulation No. 461 provides for the certificate and the costs but fixes no period
    • This is an export and free-sale certificate, not a route onto the Latvian market; the service is chargeable at EUR 185.41 under item 54 of the agency fee schedule
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    latvia-incident-signal-report

    Class Name

    Three-day signal report to ZVA after a serious incident or a potentially serious incident with a device

    Risk Level

    medium

    Pathway

    National vigilance clock under §§ 70 and 74.1 of Cabinet Regulation No. 461

    Official Timeline
    Min

    3

    Max

    3

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Medicīnisko ierīču noteikumi (Cabinet Regulation No. 461 of 15.08.2023, in force 23.08.2023; current redaction in force from 01.01.2026) — § 9 the IIa/IIb/III notification, § 11 the ten-working-day publication, §§ 28, 29 and 41.1 the LATMED registration, § 31 the ten-day LATMED entry and §§ 70 and 74.1 the three-day signal reports

    Url

    https://likumi.lv/ta/id/344674-medicinisko-iericu-noteikumi

    Effective Date

    2026-01-01

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    10

    Unit

    days

    Notes
    • Verbatim § 70: 'Ārstniecības iestādes pārstāvis triju dienu laikā pēc nopietna negadījuma vai varbūtēja nopietna negadījuma ar medicīnisko ierīci nosūta aģentūrai medicīniskās ierīces lietotāja negadījuma ziņojumu (turpmāk – signālziņojums) ... un informē ražotāju vai pilnvaroto pārstāvi, vai izplatītāju'
    • Verbatim § 74.1: the person who uses the device, or their representative, 'triju dienu laikā informē par to aģentūru, iesniedzot signālziņojumu'
    • This is a national reporting clock, not a market-entry clock, and it applies to every device class alike
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Key Requirements
  • EU Authorized Representative for non-EU manufacturers (MDR Article 11), whose place of business must be registered in Latvia and who must be entered in the LATMED database
  • Notification to ZVA before beginning to place a IIa, IIb or III class device on the Latvian market, on the notification form with the EU declaration of conformity and the valid notified-body certificates; the procedure is complete once ZVA publishes the data, within ten working days (§§ 9 and 11 of Cabinet Regulation No. 461)
  • Registration in the LATMED database — required of distributors before they make devices available (§ 41.1) and of manufacturers, importers and authorised representatives from 1 January 2026 (§ 41.2); ZVA enters the information within ten days of the application (§ 31)
  • Information for users and patients under Annex I section 23 of Regulation (EU) 2017/745 must be provided in the Latvian state language, with a narrow healthcare-institution exception subject to that institution's consent (§ 6)
  • Annual vigilance-system fee: EUR 105.20 for class I and other (remaining) devices and class A IVDs, EUR 201.90 for IIa, IIb and III devices and the listed, self-test and B, C and D IVDs, payable per manufacturer, authorised representative or distributor (Cabinet Regulation No. 895, annex items 62.1 and 62.2, funding the duty in § 30)
  • EUDAMED actor and device registration, with the first four EUDAMED modules mandatory since 28 May 2026
  • The operator of a site where a device producing ionizing radiation is used needs the notification, registration certificate or licence of the State Environmental Service Radiation Safety Centre, with state fees of EUR 97 (registration certificate) or EUR 170 (licence) under Cabinet Regulation No. 65 § 63
  • A device that is a legal measuring instrument must satisfy PTAC's state metrological supervision, including type approval or conformity assessment with initial verification and repeated verification, against the list in Cabinet Regulation No. 289
  • Electrical and electronic equipment and batteries placed on the Latvian market carry the producer registration and data-maintenance payment of Cabinet Regulation No. 331, including for the authorised representative of a foreign producer
  • Device features that are radio equipment fall under Cabinet Regulation No. 215, whose market-surveillance authority is PTAC and whose use-surveillance body is SIA 'Elektroniskie sakari'
  • Clinical investigations of medical devices and performance studies of IVDs are examined by ZVA, with documentation charges of EUR 1,500, EUR 900 for substantial modifications and EUR 900 for resumption after suspension
Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

    https://eur-lex.europa.eu/eli/reg/2017/745/oj

    Accessed Date

    2026-09-16

  • Title

    Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)

    Url

    https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj

    Effective Date

    2027-02-25

    Accessed Date

    2026-09-16

  • Title

    Medicīnisko ierīču noteikumi (Cabinet Regulation No. 461 of 15.08.2023, in force 23.08.2023; current redaction in force from 01.01.2026) — § 9 the IIa/IIb/III notification, § 11 the ten-working-day publication, §§ 28, 29 and 41.1 the LATMED registration, § 31 the ten-day LATMED entry and §§ 70 and 74.1 the three-day signal reports

    Url

    https://likumi.lv/ta/id/344674-medicinisko-iericu-noteikumi

    Effective Date

    2026-01-01

    Accessed Date

    2026-09-16

  • Title

    Zāļu valsts aģentūra — Pirms laišanas apgrozībā: Brīvās tirdzniecības sertifikāta saņemšana — 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.'

    Url

    https://www.zva.gov.lv/lv/industrijai/medicinisko-iericu-razotaji-pilnvarotie-parstavji/pirms-laisanas-apgroziba

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by ZVA. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to ZVA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    ZVA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. ZVA may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, ZVA issues Latvia market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 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.

Open Latvia fees →
Jurisdiction Id

latvia

Country

Latvia

Country Code

LV

Authority

ZVA

Low Risk Local
Min

105.2

Max

185.41

Currency

EUR

Per Product

No

High Risk Local
Min

201.9

Max

2000

Currency

EUR

Per Product

No

Details
  • Id

    class-i-and-a-class-ivd-annual-vigilance-fee

    Item

    Annual fee for maintaining the medical device vigilance system for class I and other (remaining) medical devices and class A in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 62.1)

    Currency

    EUR

    Amount Local

    105.2

    Amount Local Formatted

    EUR 105.20

    Frequency

    Per manufacturer, authorised representative or distributor, per year

    Notes

    Verbatim: 'par I klases medicīnisko ierīču un citu (pārējo) un A klases in vitro diagnostikas medicīnisko ierīču vigilances sistēmas darbības nodrošināšanu | 1 ražotājs vai 1 pilnvarotais pārstāvis, vai 1 izplatītājs | 105,20'. The charge is the statutory funding of the duty in § 30 of Cabinet Regulation No. 461, under which the persons registered under §§ 4, 28 and 29 cover the agency's vigilance-system costs each calendar year in the manner and amount set by the agency fee schedule.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    higher-class-annual-vigilance-fee

    Item

    Annual fee for maintaining the medical device vigilance system for class IIa, IIb and III (including class I) medical devices and A-list, B-list and self-test, class B, class C and class D (including class A) in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 62.2)

    Currency

    EUR

    Amount Local

    201.9

    Amount Local Formatted

    EUR 201.90

    Frequency

    Per manufacturer, authorised representative or distributor, per year

    Notes

    Verbatim: 'par IIa, IIb un III klases (ietverot arī I klases) medicīnisko ierīču, A saraksta, B saraksta un pašpārbaudes (ietverot arī citas (pārējās)), B klases, C klases un D klases (ietverot arī A klases) in vitro diagnostikas medicīnisko ierīču vigilances sistēmas darbības nodrošināšanu | 1 ražotājs vai 1 pilnvarotais pārstāvis, vai 1 izplatītājs | 201,90'. This is the line that makes the Latvian tariff genuinely risk-class-differentiated.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    free-sale-certificate

    Item

    Issue of a medical device free-sale certificate (Cabinet Regulation No. 895, annex item 54)

    Currency

    EUR

    Amount Local

    185.41

    Amount Local Formatted

    EUR 185.41

    Frequency

    Per certificate

    Notes

    Verbatim: 'Medicīniskās ierīces brīvās tirdzniecības sertifikāta izsniegšana | 1 sertifikāts | 185,41'. ZVA publishes the service period for this certificate on its own site: 'Brīvās tirdzniecības sertifikātu ZVA izsniedz 30 dienu laikā pēc iesnieguma un tam pievienoto dokumentu saņemšanas.'

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-documentation-review

    Item

    Examination of the documentation of a clinical investigation of a medical device or of a performance study of an in vitro diagnostic medical device (Cabinet Regulation No. 895, annex item 55)

    Currency

    EUR

    Amount Local

    1500

    Amount Local Formatted

    EUR 1,500.00

    Frequency

    Per documentation examination

    Notes

    Verbatim: 'Medicīnisko ierīču klīniskā pētījuma un in vitro diagnostikas medicīnisko ierīču veiktspējas pētījuma dokumentācijas ekspertīze | 1 dokumentācijas ekspertīze | 1500,00'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-substantial-modification-review

    Item

    Examination of the documentation of a substantial modification of a clinical investigation of a medical device or of a performance study of an in vitro diagnostic medical device (Cabinet Regulation No. 895, annex item 56)

    Currency

    EUR

    Amount Local

    900

    Amount Local Formatted

    EUR 900.00

    Frequency

    Per documentation examination

    Notes

    Verbatim: 'Medicīnisko ierīču klīniskā pētījuma un in vitro diagnostikas medicīnisko ierīču veiktspējas pētījuma būtisku izmaiņu dokumentācijas ekspertīze | 1 dokumentācijas ekspertīze | 900,00'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    clinical-investigation-resumption-review

    Item

    Examination of the documentation for resuming a clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device after the investigation was suspended (Cabinet Regulation No. 895, annex item 57)

    Currency

    EUR

    Amount Local

    900

    Amount Local Formatted

    EUR 900.00

    Frequency

    Per documentation examination

    Notes

    Verbatim: 'Medicīnisko ierīču klīniskā pētījuma un in vitro diagnostikas medicīnisko ierīču veiktspējas pētījuma atjaunošana pēc klīniskā pētījuma apturēšanas | 1 dokumentācijas ekspertīze | 900,00'.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    medical-device-cost-effectiveness-expertise

    Item

    Expertise on the cost-effectiveness of medical devices for one diagnosis or a group of similar diagnoses, one (single) patient group and one (single) comparable therapy (Cabinet Regulation No. 895, annex item 61)

    Currency

    EUR

    Amount Local

    1200

    Amount Local Formatted

    EUR 1,200.00

    Frequency

    Per documentation examination

    Notes

    Verbatim: 'Ekspertīze par zāļu ārstniecisko un izmaksu efektivitāti vai par medicīnisko ierīču izmaksu efektivitāti vienai diagnozei vai līdzīgu diagnožu grupai, vienai (vienotai) pacientu grupai un vienai (vienotai) salīdzināmai terapijai | 1 dokumentācijas ekspertīze | 1200,00'. The item covers both the medicines and the medical-device expertise; the device leg is what is recorded here.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    non-ce-marked-device-market-placement-review

    Item

    Examination of the application and documentation to place on the market or put into service individual medical devices or in vitro diagnostic medical devices that have not undergone the conformity assessment procedures laid down in the regulatory enactments and are not marked with the CE marking (Cabinet Regulation No. 895, annex item 63)

    Currency

    EUR

    Amount Local

    528.6

    Amount Local Formatted

    EUR 528.60

    Frequency

    Per documentation examination

    Notes

    Verbatim: 'Iesnieguma un dokumentācijas ekspertīze, lai laistu tirgū vai nodotu ekspluatācijā atsevišķas medicīniskās ierīces vai in vitro diagnostikas medicīniskās ierīces, kurām nav veiktas normatīvajos aktos paredzētās atbilstības novērtēšanas procedūras un kuras nav marķētas ar CE marķējumu | 1 dokumentācijas ekspertīze | 528,60'. This is the Latvian charge for the derogation route.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    classification-and-clinical-evaluation-consultation

    Item

    Consultation on questions concerning the classification, clinical evaluation and performance evaluation of medical devices and in vitro diagnostic medical devices (Cabinet Regulation No. 895, annex item 8.1)

    Currency

    EUR

    Amount Local

    2000

    Amount Local Formatted

    EUR 2,000.00

    Frequency

    Per consultation

    Notes

    Verbatim: 'par jautājumiem, kas skar zāļu reģistrācijas procedūras, tai skaitā par izmaiņām zāļu reģistrāciju procedūrās; par jautājumiem, kas skar medicīnisko ierīču un in vitro diagnostikas medicīnisko ierīču klasificēšanu, klīnisko izvērtēšanu un veiktspējas izvērtēšanu; par klīnisko pārbaužu preklīniskajiem, klīniskajiem un pētāmo zāļu kvalitātes jautājumiem | 1 konsultācija | 2000,00'. The item is shared with the medicines registration questions; only the device leg is recorded here. The service is optional and confirms the Union class rather than replacing the manufacturer's own Annex VIII classification.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Source Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Source Effective Date

    2025-01-01

    Verified On

    2026-09-16

  • Id

    radiation-registration-certificate-state-fee

    Item

    State fee for the issue of a registration certificate for activities with ionizing radiation sources (Cabinet Regulation No. 65, § 63.1)

    Currency

    EUR

    Amount Local

    97

    Amount Local Formatted

    EUR 97.00

    Frequency

    Per registration certificate

    Notes

    Verbatim: 'par reģistrācijas apliecības izsniegšanu darbībām ar jonizējošā starojuma avotiem – 97 euro'. § 62 requires the fee to be paid before the application is submitted, by bank transfer or through the payment module in the State Environmental Service information system. This is a use-site charge on the operator, not a device charge.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/320612-darbibu-ar-jonizejosa-starojuma-avotiem-pazinosanas-registresanas-un-licencesanas-noteikumi

    Source Title

    Darbību ar jonizējošā starojuma avotiem paziņošanas, reģistrēšanas un licencēšanas noteikumi (Cabinet Regulation No. 65 of 28.01.2021, in force 01.02.2021) — § 63 state fees for the radiation registration certificate and licence

    Source Effective Date

    2021-02-01

    Verified On

    2026-09-16

  • Id

    radiation-licence-state-fee

    Item

    State fee for the issue of a licence for activities with ionizing radiation sources (Cabinet Regulation No. 65, § 63.2)

    Currency

    EUR

    Amount Local

    170

    Amount Local Formatted

    EUR 170.00

    Frequency

    Per licence

    Notes

    Verbatim: 'par licences izsniegšanu darbībām ar jonizējošā starojuma avotiem – 170 euro'. Amendment charges sit alongside it: EUR 54 for changes to a registration certificate (§ 63.3), EUR 84 for amendments to a licence (§ 63.4) and EUR 10 for the changes listed in § 64 (§ 63.5).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://likumi.lv/ta/id/320612-darbibu-ar-jonizejosa-starojuma-avotiem-pazinosanas-registresanas-un-licencesanas-noteikumi

    Source Title

    Darbību ar jonizējošā starojuma avotiem paziņošanas, reģistrēšanas un licencēšanas noteikumi (Cabinet Regulation No. 65 of 28.01.2021, in force 01.02.2021) — § 63 state fees for the radiation registration certificate and licence

    Source Effective Date

    2021-02-01

    Verified On

    2026-09-16

Notes
  • Latvia operates no national device authorisation, so there is no authorisation fee: the fee record consists of the State Agency of Medicines charges for the acts it performs under Cabinet Regulation No. 461, plus the State Environmental Service radiation registration and licence state fees.
  • The device schedule is only partly differentiated by device risk class. The recurring annual vigilance-system fee is the one line that tracks the class axis exactly: EUR 105.20 for class I and other (remaining) medical devices and class A IVDs (item 62.1) against EUR 201.90 for class IIa, IIb and III devices and A-list, B-list and self-test, class B, C and D IVDs (item 62.2), payable per manufacturer, authorised representative or distributor. Every other line is a class-independent charge for a certificate, an expert examination or a consultation.
  • The two bands are the reporter's grouping of the published amounts: the lower band collects the recurring class I / A-class IVD vigilance fee and the free-sale certificate available to a manufacturer of any class; the upper band collects the recurring IIa/IIb/III vigilance fee and the class-independent expert charges (EUR 528.60 for placing a non-CE-marked device on the market, EUR 900 and EUR 1,500 for clinical-investigation documentation, EUR 1,200 for a cost-effectiveness expertise and EUR 2,000 for a classification and clinical-evaluation consultation). The radiation state fees sit on a separate, non-risk-class axis and are outside both bands.
  • Footnote 1 to the schedule's annex states that value added tax is not applied, under section 3(8) of the Value Added Tax Law, so every amount in this record is net of VAT.
  • The schedule was adopted on 18 December 2024 and took effect on 1 January 2025; the medical-device lines read here are items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex, and no device line was found in the schedule that is not published in this record.
  • The radiation state fees are the amounts in § 63 of Cabinet Regulation No. 65: EUR 97 for a registration certificate, EUR 170 for a licence, EUR 54 for changes to a registration certificate, EUR 84 for amendments to a licence and EUR 10 for the changes listed in § 64. They are payable before the application is submitted.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Zāļu valsts aģentūras maksas pakalpojumu cenrādis (Cabinet Regulation No. 895 of 18.12.2024, in force 01.01.2025; Latvijas Vēstnesis 249, 20.12.2024) — the medical-device items 8.1, 54, 55, 56, 57, 61, 62.1, 62.2 and 63 of the annex

    Url

    https://likumi.lv/ta/id/357532-zalu-valsts-agenturas-maksas-pakalpojumu-cenradis

    Effective Date

    2025-01-01

    Accessed Date

    2026-09-16

  • Title

    Darbību ar jonizējošā starojuma avotiem paziņošanas, reģistrēšanas un licencēšanas noteikumi (Cabinet Regulation No. 65 of 28.01.2021, in force 01.02.2021) — § 63 state fees for the radiation registration certificate and licence

    Url

    https://likumi.lv/ta/id/320612-darbibu-ar-jonizejosa-starojuma-avotiem-pazinosanas-registresanas-un-licencesanas-noteikumi

    Effective Date

    2021-02-01

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 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.

Open Latvia certifications →
Slug

latvia

Market

Latvia

Confidence

high

Schemes
  • Id

    lvd-medical-exclusion-mdr-electrical-safety

    Name

    Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Electrical Medical Equipment

    Note

    Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so no separate Latvian electrical-safety certificate exists for a medical device; electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity. The Latvian instrument transposing the Low Voltage Directive for standalone equipment was not retrieved, so this row is bound to the Union directive.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/35/oj
    Source Binding

    candidate

  • Id

    emc-directive-disapplied-by-mdr

    Name

    EMC Directive disapplied where MDR fixes the same essential requirements

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Electrical Medical Equipment

    Note

    Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route rather than a separate Latvian conformity step; where a device is also radio equipment, § 1.1 of Cabinet Regulation No. 215 brings it within the Latvian radio-equipment conformity-assessment and surveillance regime. The Latvian instrument transposing the EMC Directive for standalone equipment was not retrieved, so this row is bound to the Union directive.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/30/oj
    Source Binding

    candidate

  • Id

    ptac-radio-equipment-market-surveillance

    Name

    Radio-equipment essential requirements, conformity assessment and market surveillance (Cabinet Regulation No. 215)

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Radioiekārtu atbilstības novērtēšanas, piedāvāšanas tirgū, uzstādīšanas, lietošanas un uzraudzības noteikumi, Cabinet Regulation No. 215 of 02.04.2024, in force 11.04.2024, is made under Article 7 of the law 'Par atbildības novērtēšanu' and Article 33(2) of the Electronic Communications Law. It states the requirements for placing radio equipment on the market, for its installation and use, the market-surveillance procedure and the conformity-assessment procedure. § 2 provides verbatim that 'Radioiekārtu tirgus uzraudzību veic Patērētāju tiesību aizsardzības centrs, kas šo noteikumu izpratnē ir tirgus uzraudzības iestāde', and § 3, as amended by Cabinet Regulation No. 733 of 09.12.2025, that 'Radioiekārtu lietošanas uzraudzību veic sabiedrība ar ierobežotu atbildību "Elektroniskie sakari", kas šo noteikumu izpratnē ir lietošanas uzraudzības institūcija'. A medical device that is also radio equipment therefore carries these requirements in addition to the MDR route. The Latvian radio-equipment market-surveillance authority is PTAC, not the electronic-communications regulator and not the health inspectorate.

    Source Urls
    • https://likumi.lv/ta/id/351106-radioiekartu-atbilstibas-novertesanas-piedavasanas-tirgu-uzstadisanas-lietosanas-un-uzraudzibas-noteikumi
    Source Binding

    reviewed

  • Id

    ptac-legal-metrology-supervision

    Name

    State metrological supervision, type approval and verification of measuring instruments (PTAC)

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Legal Measuring Instruments

    Note

    Under the law 'Par mērījumu vienotību' of 27.02.1997 the state metrological control of measuring instruments consists of conformity assessment or type approval together with initial verification, the repeated verification of instruments in use, and state metrological supervision, which PTAC's own page states verbatim is 'valsts metroloģiskā uzraudzība, kuru pilnvarots veikt Patērētāju tiesību aizsardzības centrs'. Cabinet Regulation No. 289 of 14.05.2024, in force 15.07.2024, made under Article 7(2) of that law, sets the list of measuring instruments subject to state metrological control together with their initial verification and the periodicity of repeated verification. A medical device that is a legal measuring instrument (for example a sphygmomanometer or a clinical thermometer used in a regulated measurement) therefore carries its own Latvian metrological duty; the CE marking on a medical device does not discharge it. No Latvian fee amount for type approval or verification was retrieved.

    Source Urls
    • https://likumi.lv/ta/id/351985-noteikumi-par-valsts-metrologiskajai-kontrolei-paklauto-merisanas-lidzeklu-sarakstu
    • https://www.ptac.gov.lv/lv/reglamenteta-metrologija
    Source Binding

    reviewed

  • Id

    vvd-radiation-safety-centre-licensing

    Name

    Notification, registration certificate or licence for activities with ionizing radiation sources (VVD Radiation Safety Centre)

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Ionizing Radiation Sources And Equipment

    Note

    Darbību ar jonizējošā starojuma avotiem paziņošanas, reģistrēšanas un licencēšanas noteikumi, Cabinet Regulation No. 65 of 28.01.2021, in force 01.02.2021, is made under Article 5(12), Article 11(4) and (7), Article 12(2) and Article 13 of the law 'Par radiācijas drošību un kodoldrošību'. It splits activities with ionizing radiation sources into notifiable, registrable and licensable activities and requires the operator to hold whichever instrument its activity falls under. § 13.3 names the competent body verbatim as 'Valsts vides dienesta Radiācijas drošības centrs (turpmāk – centrs)'. § 62 requires the state fee to be paid before the application is submitted, by bank transfer or through the payment module in the State Environmental Service information system, and § 63 fixes the amounts: EUR 97 for a registration certificate, EUR 170 for a licence, EUR 54 for changes to a registration certificate, EUR 84 for amendments to a licence and EUR 10 for the changes listed in § 64. A medical device that produces ionizing radiation (an X-ray unit, a CT scanner, an accelerator) is in scope at the site where it is used, in addition to the MDR route and the device's own CE marking.

    Source Urls
    • https://likumi.lv/ta/id/320612-darbibu-ar-jonizejosa-starojuma-avotiem-pazinosanas-registresanas-un-licencesanas-noteikumi
    Source Binding

    reviewed

  • Id

    mk331-eee-and-battery-producer-register

    Name

    Producer registration for electrical and electronic equipment and for batteries, and the annual data-maintenance payment

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Electrical And Electronic Equipment And Batteries

    Note

    Elektrisko un elektronisko iekārtu un bateriju vai akumulatoru ražotāju reģistrācijas kārtība un samaksas kārtība par datu uzturēšanu, Cabinet Regulation No. 331 of 17.06.2014, in force 01.07.2014 (as amended by Cabinet Regulation No. 227 of 28.04.2026), is made under Article 24(2) and (4) and Article 31(3) and (4) of the Waste Management Law. § 7 requires a producer of electrical and electronic equipment to submit a registration application (Annex 1) to the registrar together with a document evidencing the advance payment referred to in § 37.1, and to be registered in the equipment producer register, which the registrar maintains; § 7.1 imposes the same on an authorised representative of a foreign producer within one month of being authorised; § 8 requires the documents for each foreign producer represented and a separate payment for each. § 22 requires a producer of batteries to submit a registration application (Annex 1.2) together with the advance payment referred to in § 37.2, the authorised representative's route being in § 23, framed by Article 56(3) of Regulation (EU) 2023/1542. The duty is therefore a producer obligation attaching to placing electrical and electronic equipment and batteries on the Latvian market. The data-maintenance payment is fixed in § 37: EUR 42.69 on registration and EUR 42.69 for each subsequent calendar year for equipment producers (§ 37.1) and the same amounts for battery producers (§ 37.2).

    Source Urls
    • https://likumi.lv/ta/id/267141
    Source Binding

    reviewed

Official Sources
  • Authority

    Latvijas Vēstnesis (likumi.lv)

    Topic

    Radioiekārtu atbilstības novērtēšanas, piedāvāšanas tirgū, uzstādīšanas, lietošanas un uzraudzības noteikumi (Cabinet Regulation No. 215 of 02.04.2024, in force 11.04.2024) — § 2 market-surveillance authority, § 3 use-surveillance body

    Url

    https://likumi.lv/ta/id/351106-radioiekartu-atbilstibas-novertesanas-piedavasanas-tirgu-uzstadisanas-lietosanas-un-uzraudzibas-noteikumi

  • Authority

    Latvijas Vēstnesis (likumi.lv)

    Topic

    Noteikumi par valsts metroloģiskajai kontrolei pakļauto mērīšanas līdzekļu sarakstu (Cabinet Regulation No. 289 of 14.05.2024, in force 15.07.2024)

    Url

    https://likumi.lv/ta/id/351985-noteikumi-par-valsts-metrologiskajai-kontrolei-paklauto-merisanas-lidzeklu-sarakstu

  • Authority

    Patērētāju tiesību aizsardzības centrs (PTAC)

    Topic

    Reglamentētā metroloģija — state metrological supervision, type approval and verification under the law 'Par mērījumu vienotību'

    Url

    https://www.ptac.gov.lv/lv/reglamenteta-metrologija

  • Authority

    Latvijas Vēstnesis (likumi.lv)

    Topic

    Darbību ar jonizējošā starojuma avotiem paziņošanas, reģistrēšanas un licencēšanas noteikumi (Cabinet Regulation No. 65 of 28.01.2021, in force 01.02.2021) — radiation registration certificate and licence, and the § 63 state fees

    Url

    https://likumi.lv/ta/id/320612-darbibu-ar-jonizejosa-starojuma-avotiem-pazinosanas-registresanas-un-licencesanas-noteikumi

  • Authority

    Latvijas Vēstnesis (likumi.lv)

    Topic

    Elektrisko un elektronisko iekārtu un bateriju vai akumulatoru ražotāju reģistrācijas kārtība un samaksas kārtība par datu uzturēšanu (Cabinet Regulation No. 331 of 17.06.2014, in force 01.07.2014)

    Url

    https://likumi.lv/ta/id/267141

  • Authority

    EUR-Lex

    Topic

    Directive 2014/35/EU (Low Voltage Directive), Annex II — electrical equipment for radiology and medical purposes excluded

    Url

    https://eur-lex.europa.eu/eli/dir/2014/35/oj

  • Authority

    EUR-Lex

    Topic

    Directive 2014/30/EU (EMC Directive), Article 2(3)

    Url

    https://eur-lex.europa.eu/eli/dir/2014/30/oj

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