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Latvia medical device registration resources

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

5 free resources23/25 topics with records7 regulations trackedSep 2026 fees reviewed
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AI medical device classifier

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Additional certification and licence checker

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Government registration fees

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Registration timeline

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Medical device regulations

Browse Latvia's official medical-device instruments — Cabinet Regulations No. 461 and No. 582, the Medical Treatment Law, and ZVA's statute and fee list — with citeable Latvian and English passages.

Structured regulatory requirements

Explore all 43 source-linked facts →

23 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
Health Inspectorate is the market surveillance authority for medical devices
statement: The Health Inspectorate (Veselības inspekcija) acts as the market surveillance authority for medical devices under the Product and Service Safety Law, the Conformity Assessment L…
State Agency of Medicines (Zāļu valsts aģentūra) is the medical device competent authority
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 i…
2 source-linked facts
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Cabinet Regulation No. 461 is the national medical device regulation
statement: The national medical device regulation is Cabinet Regulation No. 461 'Medicīnisko ierīču noteikumi' of 15 August 2023, adopted under Article 34(2)(2) (5) of the Medical Treatment…
Cabinet Regulation No. 582 is the national IVD regulation
statement: The national in vitro diagnostic medical device regulation is Cabinet Regulation No. 582 'In vitro diagnostikas medicīnisko ierīču noteikumi' of 10 October 2023, adopted under Ar…
3 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
Latvian law defines a medical device by reference to MDR Article 2(1)
statement: Latvian law contains no autonomous medical device definition: Article 1 point 21 of the Medical Treatment Law defines a medical device as any instrument, apparatus, appliance, so…
1 source-linked fact
Checked 2026-09-16
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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 · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
IVD notification procedure covers class B, C, D, A-list, B-list and self-test IVDs
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 file…
Notification procedure is the Latvian pre-market filing for class IIa, IIb and III devices
statement: An economic operator who in Latvia starts placing on the market class IIa, IIb or III medical devices files a completed notification form (Annex 1 to the regulation) with the Sta…
2 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
CE marking under the Union regulations is the domestic route; no separate Latvian approval decision
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 c…
MDR transitional periods benefit only holders of Directive 90/385/EEC or 93/42/EEC certificates
statement: The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre 2021 declaration of con…
3 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Manufacturers outside the EU must designate a sole authorised representative
statement: A manufacturer of a device that is not established in a Member State may place the device on the Union market only if it designates a sole authorised representative. Where that a…
A non-EU manufacturer may only place a device on the Union market through a sole authorised representative
statement: Under Regulation (EU) 2017/745, where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer des…
2 source-linked facts
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Devices may be distributed in Latvia only through distributors listed in LATMED
statement: Distributors referred to in paragraph 29 may make medical devices available on the Latvian market only if information about them as distributors is entered in the LATMED database…
Latvian importers must notify the Inspectorate and the agency of risky or falsified devices
statement: An importer operating in Latvia which considers, or has reason to consider, that a device it has imported and placed on the Latvian market presents a serious risk or is falsified…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
The agency verifies the EU declaration of conformity and notified-body certificates
statement: In the notification procedure the State Agency of Medicines checks the EU declaration of conformity and the certificates issued by notified bodies for conformity with the nationa…
1 source-linked fact
Checked 2026-09-16
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D10

Official forms & portals

Verified
LATMED is the Latvian medical device register, maintained by the agency
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 in…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Information for users and patients must be in Latvian
statement: Information for users and patients under Annex I section 23 of Regulation (EU) 2017/745 must be provided in the Latvian state language. That information and other device document…
IVD information for users and patients must be in Latvian
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 a…
2 source-linked facts
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Manufacturers must maintain an MDR quality management system
statement: Manufacturers of devices other than investigational devices must establish, document, implement, maintain, keep up to date and continually improve a quality management system ens…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment
Electrical safety
EMC Directive disapplied where MDR fixes the same essential requirements
EMC
Radio-equipment essential requirements, conformity assessment and market surveillance (Cabinet Regulation No. 215)
Wireless / radio
6 maintained overlays · 2 related facts
Checked 2026-09-16
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D14

Fees

Verified
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)
EUR 105.20
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)
EUR 201.90
11 maintained fee lines · 1 related fact
Checked 2026-09-16
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
ZVA publication of a IIa, IIb or III class device notification, which completes the notification procedure · National notification under § 9 of Cabinet Regulation No. 461
10 working days
ZVA entry of a manufacturer's or distributor's application into the LATMED database · National registration under §§ 28, 29 and 41.1 of Cabinet Regulation No. 461
10 days
5 maintained pathways · 5 related facts
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
LATMED registration is maintained by an annual vigilance-fee payment
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 regist…
Notified-body certificates are valid for no more than five years
statement: Certificates issued by notified bodies under Annexes IX, X and XI of Regulation (EU) 2017/745 are valid for the period they indicate, which must not exceed five years. On applica…
2 source-linked facts
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Changes to registered information must be notified within 10 working days
statement: Persons registered under paragraphs 28 and 29 of Cabinet Regulation No. 461 must inform the State Agency of Medicines within 10 working days of changes to the information they su…
Re-labelling or re-packaging requires 28 days' notice to the agency
statement: A distributor carrying out any of the activities referred to in Article 16(2)(a) and (b) of Regulation (EU) 2017/745 must inform the State Agency of Medicines at least 28 days be…
2 source-linked facts
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Healthcare institutions must store supplied UDIs electronically for at least two years
statement: Healthcare institutions must store electronically, for at least two years, the unique identifiers of the active class IIa, active class IIb and active class III medical devices s…
1 source-linked fact
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
The agency issues authorisations for medical device clinical investigations
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 i…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Exceptional national authorisation for devices without conformity assessment
statement: The State Agency of Medicines may authorise the placing on the market or putting into service of individual medical devices that have not undergone the conformity assessment proc…
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Manufacturers must run a post-market surveillance system per device
statement: For each device, manufacturers must plan, establish, document, implement, maintain and update a post market surveillance system proportionate to the risk class and appropriate fo…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Latvian healthcare institutions report incidents to the agency within three days
statement: The representative of a healthcare institution must send the State Agency of Medicines a medical device user incident report (signal report) within three days of a serious incide…
Manufacturer serious-incident reporting: 15 days, 10 days, 2 days
statement: Manufacturers of devices made available on the Union market must report any serious incident to the relevant competent authorities not later than 15 days after becoming aware of…
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
The Inspectorate may suspend placing on the market, distribution or use of a device
statement: The Health Inspectorate may suspend the placing on the market, distribution or use of a device where it classifies the device as unsafe or dangerous and its further use endangers…
1 source-linked fact
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Advertising of medical devices in Latvia — the Union rule that governs it and the national supervision layer
Latvia applies Regulation (EU) 2017/745 directly, so the operative advertising rule for medical devices is Article 7 (Claims) of the MDR: in the labelling, instructions for use, making avai…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Appeal route: review by the Ministry of Health, then the administrative court
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…
1 source-linked fact
Checked 2026-09-16
Open details →

Government fees

Full fee schedule (11 lines) →

ZVA registration fees in EUR · reviewed 2026-09-16

Fee lineAmountProvenance
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)EUR 105.20Verified
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)EUR 201.90Verified
Issue of a medical device free-sale certificate (Cabinet Regulation No. 895, annex item 54)EUR 185.41Verified
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)EUR 1,500.00Verified
7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline →

Zāļu valsts aģentūra (State Agency of Medicines) (ZVA) 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
ZVA publication of a IIa, IIb or III class device notification, which completes the notification procedure(National notification under § 9 of Cabinet Regulation No. 461)10 working days10-25 working daysVerified
ZVA entry of a manufacturer's or distributor's application into the LATMED database(National registration under §§ 28, 29 and 41.1 of Cabinet Regulation No. 461)10 days10-20 daysVerified
ZVA free-sale certificate for a device manufactured in Latvia(Paid service of the State Agency of Medicines under its published fee schedule)30 days30-45 daysVerified
1 more pathways on the full timeline · 5 of 5 clocks source-linked
  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)

Key regulations

All 7 Latvia regulations →

Official ZVA rules and guidance · 7 of 7 documents linked to official sources

Ārstniecības likumsĀrstniecības likums (Medical Treatment Law)
GeneralVerified
Regulation (EU) 2017/745Medical Devices Regulation (MDR) as it applies in Latvia
RegistrationVerified
Ministru kabineta noteikumi Nr. 461Medicīnisko ierīču noteikumi (Medical Device Regulations)
RegistrationVerified
Ministru kabineta noteikumi Nr. 537Zāļu valsts aģentūras nolikums (Statute of the State Agency of Medicines)
GeneralVerified
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