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Ministry of Health · structured requirements

🇦🇿 Azerbaijan IVD regulatory data

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

5 facts3 dimensions3 official sourceslatest verification 2026-09-17

Changes after registration

Explore questions and sources →

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

Classification rules

What local class follows from which rules and decisive product facts?

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State registration covers medical devices of medium, high and higher risk degrees

classification.risk-degree-registration-scope
Fact-level verified

Clause 1.2.3 defines registered medical devices as those of higher, high and/or medium risk degree. The registration dossier includes the manufacturer’s quality-management-system certificate and a safety-and-effectiveness conformity declaration stating the risk degree. Sterilisation and bioburden test results and validation data are required for sterile medical devices.

Conditions
  • This instrument does not establish an A/B/C/D classification scheme or the procedure for lower-risk devices.

Azerbaijani original; scoped to the registration definition and dossier requirements actually stated in this instrument.

Fees

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

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Art. 1-1 of the Law on Medicinal Products equates medical devices with medicinal products, and Art. 6.10 sends registration duty to the Law on State Duty

fees.duty-provision-extends-to-devices-by-statutory-equivalence
Fact-level verified

Art. 6.10 of the Law on Medicinal Products provides that for state registration, re-registration and registration of changes to registration documents, and for issue of a hygiene certificate, a state duty in the amount fixed by the Law on State Duty is paid. Art. 1-1 provides that, for the purposes of the Law, medical devices are treated as equivalent to medicinal products except for an enumerated list of articles; Art. 6.10 is not on that list, so the duty provision applies to device registration.

Conditions
  • The exclusion list in Art. 1-1 for devices includes 2.2, 4.1.5, 4.1.6, 4.2.4, 4.2.6, 4.2.7, 4.2.9-4.2.11, 4.2.13, 4.2.15, 4.3, 4.5-4.7, 5, the second paragraph of 6.1, 6.2, 6.3, 6.5.2, 6.5.8, 6.6-1, 6.9, 6.13, 6-1, 6-2, 8.2, 8.3, 8.6, 9.5, 9.6, 9-1, 11, 12-1, 13, 14-1, 15, 16.1-16.5 and 16-1.

English gist: Art. 1-1 'For the purposes of this Law, medical devices (except Articles ...) and medicinal substances (except ...) are treated as equivalent to medicinal products.' Art. 6.10: 'For state registration, including re-registration, of medicinal products and substances, state registration of changes in their registration documents and issue of a hygiene certificate, a state duty is paid in the amount determined by the Law on State Duty.' The elided parenthesis in the excerpt is the parallel exclusion list for medicinal substances.

State duty for state registration is 100 manat under Article 33.1 of the Law on State Duty

fees.state-registration-duty-100-manat
Fact-level verified

The Law on State Duty sets the state duty for state registration of medicinal products and substances at 100 manat (Art. 33.1), and 15 manat for issue of a hygiene certificate (Art. 33.2). This is the duty that a medical-device applicant must pay within five working days of the Analytical Expertise Centre's notification under §6.16 of the CM 345 registration Rules, because Art. 1-1 of the Law on Medicinal Products treats medical devices as medicinal products for the purposes of the Law, and Art. 6.10 (state duty for registration, re-registration and registration of changes) is not among the articles excluded from that equivalence.

Conditions
  • Art. 33.1 is worded for 'dərman vasitələrinin və maddələrinin' (medicinal products and substances); its application to devices rests on the equivalence clause in Art. 1-1 of the Law on Medicinal Products and on CM 345 §6.16, which cites Art. 1-1 and 6.10 as the basis for the device applicant's duty.
  • Under CM 345 §6.14 no state duty is charged for a duplicate certificate issued on loss or damage (already recorded).
  • The duty is a budget payment distinct from any expertise service fee of the Analytical Expertise Centre.

English gist: 'Article 33. Rates of state duty charged for state registration of medicinal products and substances and for issue of a hygiene certificate: 33.1. State registration of medicinal products and substances – 100 manat; 33.2. Issue of a hygiene certificate – 15 manat.' Art. 33 was inserted in this wording by the amending law referenced in endnote [234] of the consolidated text; the exact commencement of the current rate was not extracted.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Devices produced in or imported into Azerbaijan must be certified by an accredited conformity-assessment body under the Law on Medicinal Products, Art. 7.1

standards.mandatory-certification-by-accredited-conformity-assessment-bodies
Fact-level verified

Medical devices manufactured in Azerbaijan or imported into the country are certified, in the manner established by legislation, by the accredited conformity-assessment body of the relevant executive authority or by other accredited conformity-assessment bodies. Accreditation of those bodies is carried out under the Law on Accreditation in the Field of Conformity Assessment.

Conditions
  • The Law does not name the certification scheme or the standards against which conformity is certified; Art. 1.0.13 defines the device certificate as the document confirming conformity with the relevant technical normative legal acts.
  • This certification is separate from state registration under CM 345 and from the import documents listed in Art. 9-1.9.

English gist: 'Article 7. Certification of medicinal products, medical devices and medicinal substances. 7.1. Medical devices produced in the Republic of Azerbaijan and imported into the country are certified, in the manner established by legislation, by the accredited conformity-assessment body of the relevant executive authority or by accredited conformity-assessment bodies. 7.1-1. Accreditation of the conformity-assessment bodies referred to in Articles 7.1 and 7.2 is carried out in the manner established by the Law on Accreditation in the Field of Conformity Assessment.'

The relevant executive authority drafts and, within its powers, approves technical normative legal acts and state standards for medical devices; a device certificate attests conformity with those acts

standards.ministry-drafts-and-approves-device-technical-acts-and-state-standards
Fact-level verified

Among the powers of the relevant executive authority under the Law on Medicinal Products is to prepare, and approve within its competence, technical normative legal acts and state standards relating to medical devices (Art. 4.2.8). The Law defines the certificate of a medical device as the document confirming the device's conformity with the requirements of the relevant technical normative legal acts (Art. 1.0.13), and device quality as conformity with those acts and with the manufacturer's documents issued under them (Art. 1.0.14).

Conditions
  • The Law does not itself list the standards; no consolidated list of device-specific technical normative acts or state standards was found on e-qanun.az or the Ministry of Health / Analytical Expertise Centre sites on 2026-09-16.
  • Art. 4.2.8 is not among the articles excluded for devices by Art. 1-1.

English gist: '4.2.8. prepares technical normative legal acts and state standards relating to medical devices and approves them within its powers; 1.0.13. certificate of medical devices – a document confirming the conformity of medical devices with the requirements of the relevant technical normative legal acts; 1.0.14. quality of medical devices – conformity of medical devices with the relevant technical normative legal acts and with the documents issued by the manufacturer on the basis of those requirements.' Endnotes [10]-[11] and [33] record that 'dövlət standartlarının' was replaced by 'texniki normativ hüquqi aktların' in the definitions by a later amendment.

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 Azerbaijan registration →
Country

Azerbaijan

Jurisdiction Id

azerbaijan

Country Code

AZ

Flag

🇦🇿

Regulator

Ministry of Health of the Republic of Azerbaijan

Regulator Abbrev

Ministry of Health

Region

europe

Tier

3

Risk Classification

Four risk degrees set by Ministry of Health Collegium Decision No. 8 of 21 May 2024 §3.3 — sinif 1 (low), sinif 2a (medium), sinif 2b (high) and sinif 3 (the highest), with in vitro diagnostic devices expressly outside the scale; only the increased, high and medium degrees are state-registered, per Cabinet Resolution No. 345 §1.2.3

Classes
  • Id

    registration-class-2a

    Class Name

    Sinif 2a (medium risk) — state registration

    Risk Level

    medium

    Pathway

    National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry

    Official Timeline
    Min

    7

    Max

    7

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3, §3.4, §6.16, §7.1, §7.3, §7.4, §7.8, §7.12 and §8.1

    Url

    https://nk.gov.az/uploads/doc/docs/669a148e21f1e.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • The seven-working-day clock of §7.1 is the Ministry's own decision time and applies where the submitted documents are free of deficiencies; it starts from submission of the application, or from the date the deficiency is cured where one was notified.
    • The Analytical Expertise Center's expertise time sits largely outside that clock (§7.12), which is why the planning range is in months while the published clock is in days.
    • Where deficiencies are notified, §7.3 gives the Ministry five working days from registration of the application to raise them and §7.4 gives the applicant a cure period; a certificate for a change to a registered device is issued within seven working days of the expertise opinion reaching the Ministry (§7.2, §6.12).
    Clinical Trial Required

    No

    Local Testing Required

    Yes

    Gmp Required

    No

  • Id

    registration-class-2b

    Class Name

    Sinif 2b (high risk) — state registration

    Risk Level

    high

    Pathway

    National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry

    Official Timeline
    Min

    7

    Max

    7

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3, §3.4, §6.16, §7.1, §7.3, §7.4, §7.8, §7.12 and §8.1

    Url

    https://nk.gov.az/uploads/doc/docs/669a148e21f1e.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    8

    Max

    15

    Notes
    • Same seven-working-day Ministry clock as the other registerable degrees (§7.1); the degree changes the depth of the expertise file, not the published decision period.
    • The registration certificate is valid for five years (§8.1), and every change to the information in the registration documents must be registered, the holder applying within seven working days (§7.8).
    • The dossier for a device containing a medicinal substance as a component must additionally have that substance examined before registration (§4.4).
    Clinical Trial Required

    No

    Local Testing Required

    Yes

    Gmp Required

    No

  • Id

    registration-class-3

    Class Name

    Sinif 3 (highest risk) — state registration

    Risk Level

    highest

    Pathway

    National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry

    Official Timeline
    Min

    7

    Max

    7

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3, §3.4, §6.16, §7.1, §7.3, §7.4, §7.8, §7.12 and §8.1

    Url

    https://nk.gov.az/uploads/doc/docs/669a148e21f1e.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    10

    Max

    18

    Notes
    • Same seven-working-day Ministry clock (§7.1); the realistic range reflects the fuller clinical and technical file the highest degree carries through the expertise stage.
    • Every consignment must additionally be supported at import by the documents Article 9-1.9 of the Law on Medicinal Products requires, including the certificate of origin and the manufacturer's batch quality document.
    Clinical Trial Required

    No

    Local Testing Required

    Yes

    Gmp Required

    No

Prior Approvals
  • Authority

    US FDA 510(k)/PMA

    Accepted

    No

    Benefit

    No recognition route exists for devices: the foreign-registration recognition mechanism in the registration Rules is confined to medicinal products, so an FDA clearance neither opens an abridged procedure nor substitutes for the Ministry of Health certificate. It may serve as supporting technical documentation in the expertise file.

  • Authority

    EU CE marking under MDR/IVDR

    Accepted

    No

    Benefit

    Same position: the recognition list approved by Cabinet Resolution No. 480 of 26 December 2023 is applied to medicinal products only, so a CE mark does not displace the national dossier and expertise.

  • Authority

    EAEU marketing authorisation

    Accepted

    No

    Benefit

    Azerbaijan is not a member of the Eurasian Economic Union and has no instrument recognising an EAEU medical-device marketing authorisation; the EAEU registration route does not apply to this market.

  • Authority

    MDSAP

    Accepted

    No

    Benefit

    No MDSAP acceptance was evidenced in any Azerbaijani instrument read this round.

Key Requirements
  • Determine the device's risk degree against the four-degree scale of Ministry of Health Collegium Decision No. 8 of 21 May 2024 §3.3 and check the device against the risk list approved by Collegium Decision No. 7 of 21 May 2024; a device of medium, high or increased degree must be state-registered before it is imported, manufactured, sold or used (Cabinet Resolution No. 345, §1.2.3, §1.6).
  • File the registration application with the Ministry of Health in the Annex No. 1 form and pay the state duty within five working days of the Analytical Expertise Center's notification (§6.16).
  • Carry the registration through expertise by the Analytical Expertise Center and obtain the registration certificate (qeydiyyat vəsiqəsi) from the Ministry of Health, valid for five years (§8.1).
  • Register every change to the information in the registration documents, applying to the Ministry within seven working days (§7.8).
  • For an import consignment, present the documents Article 9-1.9 of the Law on Medicinal Products requires, including a copy of the certificate of origin, proof of rights over the storage and import premises, a notarially certified copy of the sale-purchase contract, invoices identifying each device by full name, serial number and expiry or service life, and the manufacturer's quality-results document for each batch; used devices additionally need a manufacturer or seller document on serviceability (Article 9-1.10).
  • Where the device measures and is used in healthcare, obtain type approval for the measuring instrument and have it verified before being put into service and periodically thereafter (Law 686-IVQ, §11.1, §11.3, §12.1).
  • Where the device contains a radio module, obtain the radio-frequency allocation from the State Commission on Radio Frequencies under Cabinet Decision No. 22 of 1 February 2007 §2.1, supporting the application with the manufacturer's certificate and the State Radio Frequencies Administration's opinion on the planned frequencies and electromagnetic compatibility (§2.12); equipment without a conformity certificate may not be used on a radio network (§2.34).
  • Where the device is or contains an ionizing-radiation source, hold the Annex No. 3 permit under the Law on Licences and Permits 176-VQ for its operation, and obtain the State Agency for Regulation of Nuclear and Radiological Activity's opinion for its import.
Local Rep Required

Yes

Local Rep Name

Applicant (ərizəçi) established in Azerbaijan — the manufacturer, a wholesale pharmaceutical enterprise, the inventor or the Ministry of Health itself, filing with the Ministry through the Annex No. 1 application form; there is no separate authorised-representative institution and no evidence that a foreign manufacturer may file directly

Mdsap Accepted

No

Mdsap Benefit

None evidenced. The registration Rules require the manufacturer's quality documentation as part of the dossier rather than a certified quality-management-system audit, and no instrument read this round names MDSAP or any equivalent.

Registration Validity

5 years — Cabinet Resolution No. 345 §8.1: the registration certificate issued for a medicinal product, medicinal substance or medical device is valid for five years.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3, §3.4, §6.16, §7.1, §7.3, §7.4, §7.8, §7.12 and §8.1

    Url

    https://nk.gov.az/uploads/doc/docs/669a148e21f1e.pdf

    Accessed Date

    2026-09-16

  • Title

    Cabinet Resolution No. 345 of 18 July 2024 as registered on the legal portal — citation 345, adopted 18.07.2024, in force 19.07.2024, register code 14202407180345, status Qüvvədədir

    Url

    https://e-qanun.az/frameworks/57/f_57583.html

    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 Ministry of Health. Appoint a Applicant (ərizəçi) established in Azerbaijan — the manufacturer, a wholesale pharmaceutical enterprise, the inventor or the Ministry of Health itself, filing with the Ministry through the Annex No. 1 application form; there is no separate authorised-representative institution and no evidence that a foreign manufacturer may file directly.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Ministry of Health 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. Ministry of Health may issue questions.

    Duration

    7 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Ministry of Health issues Azerbaijan market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 0 records

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

No maintained record.

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 Azerbaijan certifications →
Slug

azerbaijan

Market

Azerbaijan

Confidence

high

Schemes
  • Id

    azerbaijan-state-registration-import-gate

    Name

    State registration by the Ministry of Health as the condition of import and sale

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Finished Device

    Note

    Cabinet Resolution No. 345 of 18 July 2024 §1.6 provides that medical devices are state-registered by the Ministry of Health, entered in the state register, and only then permitted to be imported into Azerbaijan, manufactured, sold and used there. §1.2.3 confines the Rules to devices of increased, high and medium risk, so a class 1 device is not registered; §7.1 requires the Ministry to issue the registration certificate (qeydiyyat vəsiqəsi) within seven working days where the documents are free of deficiencies. The Analytical Expertise Center performs the expertise; the Ministry issues the certificate. There is no abridged, recognition, fast-track or notification route for devices, whatever foreign approval the device holds.

    Source Urls
    • https://nk.gov.az/uploads/doc/docs/669a148e21f1e.pdf
    • https://e-qanun.az/frameworks/57/f_57583.html
    Source Binding

    reviewed

  • Id

    azerbaijan-legal-metrology-type-approval

    Name

    Legal metrology type approval and verification

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Measuring Instrument

    Note

    The Law on Ensuring the Uniformity of Measurements (686-IVQ of 13 June 2013) makes healthcare a state-regulated field of measurement (§2.2.1) and makes the requirements for measuring instruments applied there mandatory (§2.5). A measuring instrument used in that field must have its type approved (§11.1), the approval being confirmed by a certificate issued by the relevant executive authority (§11.3), and must pass initial verification before being put into service and periodic verification during use (§12.1), evidenced by a mark and/or a certificate (§12.5). Type approval is a pre-market approval of the instrument and verification an ongoing condition of its use. The law names no body, referring throughout to the relevant executive authority; the text is published by the Azerbaijan Metrology Institute under the State Antimonopoly and Consumer Market Control Agency.

    Source Urls
    • https://metrology.gov.az/storage/pages/34/686-ivq-olcmelerin-vehdetinin-temin-edilmesi-haqqinda.pdf
    Source Binding

    reviewed

  • Id

    azerbaijan-radio-frequency-allocation-and-conformity

    Name

    Radio-frequency allocation permit and radio-equipment conformity certificate

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Cabinet Decision No. 22 of 1 February 2007 governs the allocation, registration, use and charging of radio frequencies. §2.1 requires legal and natural persons to apply in writing to the State Commission on Radio Frequencies for allocation of frequency bands for radio-electronic means (REV) manufactured, modernised or imported into Azerbaijan and intended for operation; §2.12 requires among the documents the certificate issued by the manufacturer and the State Radio Frequencies Administration's opinion on the planned frequencies and on the electromagnetic compatibility of the radio-electronic means used on them; §2.34 forbids the use in radio networks of equipment that has no conformity certificate or is faulty. The trigger is stated for imported radio-electronic means rather than for a device category, so it reaches any medical device with a radio module and bites at import and again at use.

    Source Urls
    • https://e-qanun.az/frameworks/12/f_12841.html
    Source Binding

    reviewed

  • Id

    azerbaijan-emc-technical-regulation

    Name

    Electromagnetic compatibility technical regulation — draft, not in force

    Category

    emc

    Status

    Transition Not Yet Mandatory

    Object

    Covered Product Or Component

    Note

    The Law on Technical Regulation (1669-VQ of 30 September 2019) is a framework: it delegates the adoption of technical regulations to the body designated by the relevant executive authority (Art. 7.1) and provides that only high-risk goods undergo mandatory certification, medium and low-risk goods being declared instead (Art. 13.3). Cabinet Decision No. 61 of 6 March 2025 lists electromagnetic-compatibility technical means among the goods a technical regulation would cover (§11), but a scope list fixes coverage, not requirements. The electromagnetic-compatibility technical regulation itself is still a draft: the text published by the State Antimonopoly and Consumer Market Control Agency carries the watermark «Layihə» (draft) on every page and a blank adoption date and number. No EMC technical regulation is in force for Azerbaijan, so an EMC certificate is not a present pre-market condition for a medical device; this row records the transition.

    Source Urls
    • https://e-qanun.az/frameworks/43/f_43689.html
    • https://e-qanun.az/frameworks/59/f_59119.html
    • https://competition.gov.az/storage/technical_regulations/Mho61zZowucYixurNw6qzkpN9gbpifo3RM1fLKnt.pdf
    Source Binding

    reviewed

  • Id

    azerbaijan-low-voltage-technical-regulation

    Name

    Low-voltage equipment safety technical regulation — draft, not in force

    Category

    Medical Electrical Safety

    Status

    Transition Not Yet Mandatory

    Object

    Covered Product Or Component

    Note

    The position mirrors the EMC row. The Law on Technical Regulation (1669-VQ) delegates technical regulations to the designated executive body (Art. 7.1) and reserves mandatory certification to high-risk goods (Art. 13.3), and Cabinet Decision No. 61 of 6 March 2025 lists low-voltage electrical installations and equipment among the goods a technical regulation would cover (§10) without imposing any requirement itself. The State Antimonopoly and Consumer Market Control Agency published the low-voltage and electromagnetic-compatibility draft technical regulations together for public hearing on 21 November 2025, which is the standing evidence that the regulation was a draft and not an adopted instrument at that date and that no earlier text is in force. A medical electrical device consequently carries no Azerbaijani low-voltage conformity certificate today.

    Source Urls
    • https://e-qanun.az/frameworks/43/f_43689.html
    • https://e-qanun.az/frameworks/59/f_59119.html
    • https://competition.gov.az/az/post/1160/asagigerginlikli-elektrik-qurgu-ve-avadanliqlari-ve-texniki-vasitelerin-elektromaqnit-uzlasmasina-dair-texniki-reqlament-layiheleri-ictimai-dinleme-ve-muzakireye-cixarilacaq
    Source Binding

    reviewed

  • Id

    azerbaijan-ionizing-radiation-permit

    Name

    Ionizing-radiation source permit and import opinion

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Emitting Equipment

    Note

    The Law on Licences and Permits (176-VQ of 15 March 2016) fixes in its Annex No. 3 the permits required for activities involving ionizing-radiation sources, and §4.3 makes that annex the authoritative list. Item 23 covers the design, manufacture, placement, construction, operation and decommissioning of devices regarded as ionizing-radiation sources; item 24 covers the design and manufacture of process equipment and radiation-safety means for such devices; item 22 covers research and development work using them. The activity is permitted rather than licensed for these items, and the permit is a condition of operating the equipment. The licensing body's statute, approved by Presidential Decree No. 74 of 3 April 2009, gives the State Agency for Regulation of Nuclear and Radiological Activity within the Ministry of Emergency Situations the power to permit the keeping of radioactive substances and ionizing-radiation sources at workplaces and stores (§8.6) and to give the opinion required for their import, export, re-export, re-import and transit (§8.9), so the same regime bites at import for the sources it reaches.

    Source Urls
    • https://e-qanun.az/frameworks/32/f_32626.html
    • https://faolex.fao.org/docs/pdf/aze231698.pdf
    Source Binding

    reviewed

  • Id

    azerbaijan-producer-responsibility-not-in-force

    Name

    No producer-responsibility obligation for waste electrical equipment, batteries or packaging

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Finished Device

    Note

    No producer-responsibility instrument covering waste electrical and electronic equipment, batteries or packaging is in force for an importer of medical devices in Azerbaijan. The Law on Waste (514-IQ of 30 June 1998) remains in force, but its producer-responsibility articles (14-1 to 14-10) establish only the motor-vehicle utilisation scheme, which does not reach medical devices, and no separate WEEE, battery, accumulator or packaging decree imposing registration, reporting, take-back, a fee or labelling on an importer was located. The environmental trigger is therefore published as a verified negative.

    Source Urls
    • https://e-qanun.az/frameworks/3/f_3186.html
    Source Binding

    reviewed

Official Sources
  • Authority

    Ministry of Health of the Republic of Azerbaijan

    Topic

    Cabinet Resolution No. 345 of 18 July 2024 — Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices

    Url

    https://nk.gov.az/uploads/doc/docs/669a148e21f1e.pdf

  • Authority

    Cabinet of Ministers of the Republic of Azerbaijan

    Topic

    Cabinet Resolution No. 345 of 18 July 2024 as registered on the legal portal (citation 345, in force 19.07.2024, register code 14202407180345)

    Url

    https://e-qanun.az/frameworks/57/f_57583.html

  • Authority

    Azerbaijan Metrology Institute / State Antimonopoly and Consumer Market Control Agency

    Topic

    Law on Ensuring the Uniformity of Measurements 686-IVQ — §2.2.1 healthcare as a state-regulated field, §11 type approval, §12 verification

    Url

    https://metrology.gov.az/storage/pages/34/686-ivq-olcmelerin-vehdetinin-temin-edilmesi-haqqinda.pdf

  • Authority

    Cabinet of Ministers of the Republic of Azerbaijan

    Topic

    Cabinet Decision No. 22 of 1 February 2007 — Rules for the allocation, registration, use and charging of radio frequencies (§2.1, §2.12, §2.34)

    Url

    https://e-qanun.az/frameworks/12/f_12841.html

  • Authority

    Cabinet of Ministers of the Republic of Azerbaijan

    Topic

    Law on Technical Regulation 1669-VQ of 30 September 2019 — Article 7.1 delegation and Article 13.3 certification of high-risk goods only

    Url

    https://e-qanun.az/frameworks/43/f_43689.html

  • Authority

    Cabinet of Ministers of the Republic of Azerbaijan

    Topic

    Cabinet Decision No. 61 of 6 March 2025 — list of goods covered by a technical regulation (§10 low-voltage equipment, §11 electromagnetic-compatibility technical means)

    Url

    https://e-qanun.az/frameworks/59/f_59119.html

  • Authority

    State Antimonopoly and Consumer Market Control Agency

    Topic

    Draft electromagnetic-compatibility technical regulation published for public consultation, watermark «Layihə» (draft)

    Url

    https://competition.gov.az/storage/technical_regulations/Mho61zZowucYixurNw6qzkpN9gbpifo3RM1fLKnt.pdf

  • Authority

    State Antimonopoly and Consumer Market Control Agency

    Topic

    Notice of public hearing on the draft low-voltage and electromagnetic-compatibility technical regulations, 21 November 2025

    Url

    https://competition.gov.az/az/post/1160/asagigerginlikli-elektrik-qurgu-ve-avadanliqlari-ve-texniki-vasitelerin-elektromaqnit-uzlasmasina-dair-texniki-reqlament-layiheleri-ictimai-dinleme-ve-muzakireye-cixarilacaq

  • Authority

    Ministry of Emergency Situations — State Agency for Regulation of Nuclear and Radiological Activity

    Topic

    Law on Licences and Permits 176-VQ of 15 March 2016 — Annex No. 3 items 22 to 25, permits for ionizing-radiation source activity

    Url

    https://e-qanun.az/frameworks/32/f_32626.html

  • Authority

    State Agency for Regulation of Nuclear and Radiological Activity

    Topic

    Statute approved by Presidential Decree No. 74 of 3 April 2009, §8.6 and §8.9 — powers to permit keeping of ionizing-radiation sources and to give the import opinion (FAO-hosted copy of the official text)

    Url

    https://faolex.fao.org/docs/pdf/aze231698.pdf

  • Authority

    Cabinet of Ministers of the Republic of Azerbaijan

    Topic

    Law on Waste 514-IQ of 30 June 1998 — no producer-responsibility obligation for electrical equipment, batteries or packaging

    Url

    https://e-qanun.az/frameworks/3/f_3186.html

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