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Ministry of Health · structured requirements

🇦🇿 Azerbaijan medical device regulatory data

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

31 facts23 dimensions7 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising of medical-purpose equipment in Azerbaijan requires that its use be authorised by the relevant executive authority and confines such advertising to medical-professional channels

advertising.equipment-needs-authorised-use-and-professional-channels
Fact-level verified

Article 16-1 of the Law on Medicinal Products governs advertising in Azerbaijan and names medical equipment in its own terms. Article 16-1.1 provides that in the Republic of Azerbaijan only medicinal products dispensed without a prescription, medical-purpose equipment ('tibbi təyinatlı texnika') whose use (application) has been authorised by the relevant executive authority, and treatment, prophylaxis, diagnosis and rehabilitation methods may be advertised — so an advertisement for equipment whose use has not been authorised by that authority is outside the permitted class. Article 16-1.4 requires the advertiser of prescription-free medicinal products, medical-purpose equipment and such methods to provide the advertising producer and the advertising distributor, on their request, with copies of the certificate issued by the Ministry of Health's accredited conformity-assessment body or by accredited conformity-assessment bodies, of the registration certificate confirming the state registration of the product, of the instructions for use (or, where the instructions do not state the dispensing arrangement, of a document containing the relevant information), of the certificate of origin, and, where research results are referred to in the advertisement, of the document confirming the research results. Article 16-1.6 provides that, subject to articles 16-1.1 and 16-1.4, advertising of products requiring special preparation for use, and of medical equipment, may be published only in press outlets specialised in the medical field and at events held for medical workers and pharmacists. Article 16-1.5 requires an advertisement to state that use of prescription-free medicinal products and use of medical equipment is accompanied by adverse effects where that is the case, and to note the need to consult a doctor or specialist. Article 16-1.7 prohibits advertising campaigns accompanied by the free distribution or sale of medicinal products or by the provision of paid or free medical services. Article 16-1.3 disapplies the article 16-1.2.2 and 16-1.2.3 prohibitions (reference to concrete cases of recovery, and expressions of gratitude) to advertising published at exhibitions, seminars and conferences connected with medicine or pharmacy.

Conditions
  • The article's term is 'tibbi təyinatlı texnika' (medical-purpose equipment) and 'tibbi texnika' (medical equipment), not the defined term 'tibb vasitəsi' (medical device) of article 1.0.1 of the Law; the bounded claim is therefore stated in the article's own vocabulary, and its reach over any given device turns on whether that device is medical-purpose equipment.
  • Article 1-1 of the Law excludes article 16-1 from the device-equivalence clause, so article 16-1 reaches equipment by its own express words rather than through the deeming clause — the same structure as article 9-1, which also regulates devices expressly while being listed in the carve-out.
  • The article prohibits advertising outside the permitted class rather than requiring a pre-clearance approval for each advertisement; the enforcement instrument named in the article is the advertiser's duty to supply supporting certificates on request under article 16-1.4.
  • Article 16-1.8 routes advertising of biologically active food supplements to article 30 of the Law on Advertising; no equivalent express device carve-out to the Law on Advertising was found in the articles read.

Source language is Azerbaijani; passages are quoted in the original with an English translation. Retrieved 2026-09-16 over direct HTTPS from the National Legal Information System's generated PDF of the consolidated Law on Medicinal Products No. 208-IIIQ (HTTP 200, application/pdf, 461270 bytes).

Approval validity & renewal

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

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Registration certificate valid 5 years; renewal filed at least 7 working days before expiry

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Fact-level verified

A registration certificate issued for a medical device is valid for 5 years. An applicant may apply to the Ministry for re-registration at least 7 (seven) working days before the certificate expires; the re-registered certificate takes effect on the day following the day the previous certificate lapses.

Conditions
  • For medicinal products and medicinal substances the re-registration window is longer (at least 90 calendar days, §6.8); the 7-working-day window is the device figure in §7.8.
  • The certificate holder must apply to the Ministry within 7 working days to register a change to the device's registration documents (§7.8).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §8.1: "8.1. Dərman vasitəsinə, dərman maddəsinə və tibb vasitəsinə verilən qeydiyyat vəsiqəsi 5 (beş) il müddətində qüvvədə olur." Translation: "8.1. A registration certificate issued for a medicinal product, a medicinal substance and a medical device shall be valid for 5 (five) years." Verbatim §7.8: "7.8. Ərizəçi tibb vasitəsinin yenidən dövlət qeydiyyatına alınması məqsədilə qeydiyyat vəsiqəsinin qüvvədəolma müddətinin bitməsinə azı 7 (yeddi) iş günü qalmış Nazirliyə müraciət edilə bilər. Tibb vasitələrinin qeydiyyat sənədlərində edilmiş dəyişikliyin dövlət qeydiyyatına alınması məqsədilə vəsiqə sahibi 7 (yeddi) iş günü müddətində Nazirliyə müraciət etməlidir." Translation: "7.8. An applicant may apply to the Ministry at least 7 (seven) working days before the expiry of the validity period of the registration certificate for the purpose of re-registration of a medical device. For the purpose of registering a change made to the registration documents of medical devices, the certificate holder must apply to the Ministry within 7 (seven) working days."

Authority & regime

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

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Ministry of Health grants device registration; Analytical Expertise Center performs the expertise

authority.registration-granted-by-ministry-of-health
Fact-level verified

State registration of medical devices is granted by the Ministry of Health (Səhiyyə Nazirliyi) of the Republic of Azerbaijan, which enters the device in the state register and thereby authorises its import into, manufacture in, sale in and use in Azerbaijan. The technical expertise on which registration is based is carried out by the Analytical Expertise Center ('Analitik Ekspertiza Mərkəzi'), a public-law entity of the Ministry. The state register is maintained by the Ministry through the Center, in electronic form, on the websites of both bodies.

Conditions
  • The Center is the expert institution, not the registering authority — the registration certificate is issued by the Ministry.
  • Register entries for devices include brand name, device type, risk degree, primary/secondary packaging description, accessories, GMDN code, and — for a device containing a medicinal substance — the active substance and dose.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §1.6 (line breaks removed): "1.6. Dərman vasitələri, dərman maddələri və tibb vasitələri Qanunun 6.14-cü maddəsi nəzərə alınmaqla Azərbaycan Respublikasının Səhiyyə Nazirliyi (bundan sonra - Nazirlik) tərəfindən dövlət qeydiyyatına alınaraq dövlət reyestrinə daxil edilir və Azərbaycan Respublikasının ərazisinə idxalına, Azərbaycan Respublikasının ərazisində istehsalına, satışına və istifadəsinə icazə verilir." Translation: "1.6. Medicinal products, medicinal substances and medical devices shall, taking into account Article 6.14 of the Law, be state-registered by the Ministry of Health of the Republic of Azerbaijan (hereinafter — the Ministry) and entered in the state register, and their import into the territory of the Republic of Azerbaijan, manufacture, sale and use in the territory of the Republic of Azerbaijan shall be permitted." §3.1 names the expert body: "...ekspertizanın “Analitik Ekspertiza Mərkəzi” publik hüquqi şəxsi (bundan sonra – Qurum) tərəfindən keçirilməsi..." — "...the conduct of the expertise by the public-law entity 'Analytical Expertise Center' (hereinafter — the Center)...".

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Any change to the data in registration documents must be state-registered

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Fact-level verified

Where any change is made to the information reflected in the documents listed in Parts 3 and 4 of the Rules for a registered medical device, that change must be state-registered. Where the change alters data shown on the registration certificate, a new certificate is drawn up retaining the registration number, the date of registration of the change is recorded, and the new certificate's validity is limited to the remaining term of the previous one. Changes that do not affect data on the certificate are state-registered without issuing a new certificate.

Conditions
  • The certificate for a change is issued within 7 working days of the expertise opinion reaching the Ministry (§7.2, §6.12).
  • The state duty is payable for registration of a change (§6.12, §6.16).
  • The rules do not create Type IA/IB/II variation classes for devices as they do for medicinal products; the device rule is a single registration duty.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §1.5: "1.5. Dövlət qeydiyyatına alınmış dərman vasitələrinin, dərman maddələrinin və tibb vasitələrinin qeydiyyatı üçün tələb olunan bu Qaydaların müvafiq olaraq 3-cü və 4-cü hissələrində göstərilən sənədlərdə əks olunan məlumatlarda hər hansı dəyişiklik edilərsə, həmin dəyişikliklər dövlət qeydiyyatına alınmalıdır." Translation: "1.5. If any change is made to the information reflected in the documents indicated in Parts 3 and 4 of these Rules respectively, required for the registration of state-registered medicinal products, medicinal substances and medical devices, those changes must be state-registered." Verbatim §7.2 (opening and closing): "7.2. Qeydiyyat vəsiqəsində əks olunan məlumatlarda hər hansı bir dəyişiklik olunduqda, qeydiyyat nömrəsi saxlanılmaqla yeni qeydiyyat vəsiqəsi tərtib edilir. ... Yeni qeydiyyat vəsiqəsinin qüvvədəolma müddəti əvvəlki qeydiyyat vəsiqəsinin qüvvədəolma müddəti ilə məhdudlaşır." Translation: "7.2. Where any change is made to the information reflected on the registration certificate, a new registration certificate shall be drawn up retaining the registration number. ... The validity period of the new registration certificate shall be limited to the validity period of the previous registration certificate."

Clinical investigation & performance

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

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A medical device used in a clinical investigation in Azerbaijan is exempt from state registration but may be used only by decision of the relevant executive authority

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Fact-level verified

Under article 6.5.4 of the Law on Medicinal Products, products intended for the conduct of scientific research, preclinical research and clinical trials are among the products that are not subject to state registration, and the use of those products is permitted only where there is a decision of the relevant executive authority. Medical devices are equated to medicinal products for the purposes of article 6.5.4: the device-equivalence clause in article 1-1 excludes articles 6.5.2 and 6.5.8 from the deeming but not article 6.5.4. The rules for conducting scientific research, preclinical research and clinical trials of medicinal products are established by the relevant executive authority (article 6.9); those rules are the Rules approved by Cabinet Decision No. 83 of 30 April 2010, under which a clinical trial is carried out on the basis of an authorisation of the Ministry of Health (article 1.5) and in medical-prophylactic institutions designated by the Ministry and accredited (article 4.1); all clinical trials must be conducted in accordance with the ethical principles of the Helsinki Declaration (1964) and the Ministry's rules on protection of trial subjects, and only where the expected benefit outweighs the risk (article 4.2); trials on a human being may be conducted only with that person's written informed consent and under a contract between the person and the sponsor, and after positive results have been obtained in scientific and preclinical research on animals (article 4.3); supervision of compliance with legal and ethical norms during preclinical research is exercised by the Ministry of Health or a body it authorises (article 1.2). Trials are prohibited on minors (article 4.5.1), pregnant women (article 4.5.2), persons in military service (article 4.5.3), convicted and detained persons (article 4.5.4) and persons declared incapacitated by a court (article 4.5.5), subject in the cases of minors, pregnant women and psychiatric patients to an exception where the medical technology under trial is specifically designated for the treatment of that population.

Conditions
  • The bounded claim on the Law rests on article 6.5.4 being absent from the article 1-1 carve-out list for medical devices, so that article 6.5.4 reaches devices through the deeming clause; article 6.9 is in that carve-out list and is therefore stated for medicinal products.
  • Cabinet Decision No. 83 is made under article 6.9 and its scope clause (article 1.4) applies it to all types of clinical trials of medicinal preparations; its references to medical technology appear in the vulnerable-population exceptions (articles 4.5.1, 4.5.2 and 4.5.5) and in the ban on trials of designated medical technology outside the intended population. The device reach of Decision No. 83 is therefore partial and is asserted only to that extent.
  • No device-specific clinical-investigation instrument was found in the sources searched; the registration Rules (Cabinet Decision No. 345) require a manufacturer's declaration of conformity with safety and effectiveness requirements for a device (Rules 4.2.8) and sterility, pyrogenicity and bioburden validation data for sterile devices (Rules 4.2.7), but do not require clinical-investigation data in the registration dossier.

Sources are in Azerbaijani; passages are quoted in the original with an English translation. The Law was retrieved 2026-09-16 over direct HTTPS from the National Legal Information System's generated PDF of the consolidated text (HTTP 200, application/pdf, 461270 bytes); Cabinet Decision No. 83 of 30 April 2010 (e-qanun.az framework 19529, status 'Qüvvədədir') was retrieved 2026-09-16 over direct HTTPS from the National Legal Information System's static export (HTTP 200, text/html, 190350 bytes).

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Devices identified by GMDN; non-separable accessories registered with the device

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Fact-level verified

The Rules identify medical devices using the Global Medical Device Nomenclature (GMDN) — 'the international system of codes and terms adopted for the purpose of identifying medical devices' — and record the GMDN code in the state register. Accessories ('komplektləşdiricilər', defined as blocks, parts, elements, materials and spare parts that are not themselves the device or a device accessory but are intended by the manufacturer for use in or with the device) that are not independently usable are registered together with the device as a set, not separately.

Conditions
  • The GMDN code is a mandatory entry in the device register (§10.4.6).
  • There is no separate national device definition in the Rules; scope is determined by the Law on Medicinal Products, Article 1.0.8.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §2.1.2: "2.1.2. tibb vasitələrinin qlobal nomenklaturası (bundan sonra - TVQN) – tibb vasitələrinin identifikasiya edilməsi məqsədilə qəbul edilmiş kod və terminlərin beynəlxalq sistemi;" Translation: "2.1.2. global nomenclature of medical devices (hereinafter — GMDN) — the international system of codes and terms adopted for the purpose of identifying medical devices;". Verbatim §7.10: "7.10. Tibb vasitələrinin tərkibinə daxil olan və müstəqil şəkildə istifadə edilməyən komplektləşdiricilər həmin tibb vasitəsilə dəst şəklində qeydiyyata alınır." Translation: "7.10. Accessories included in a medical device and not used independently shall be registered together with that medical device as a set."

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Medical-device registration dossier (Part 4 of the Rules)

dossier.device-registration-document-set
Fact-level verified

The device registration dossier submitted to the Ministry with the Annex No. 1 application comprises: a copy of the document confirming the manufacturer's right to manufacture, with its annex; the origin/registration evidence of §4.2.2 (notarised Azerbaijani translation); the manufacturer's short description of the device's fields of application, intended purpose and accessories; the manufacturer's labelling and packaging information including colour mock-ups and Azerbaijani-language content; where the device contains a medicinal substance, its composition, quantity and compatibility data; the manufacturer's biological safety information; for sterile devices, a notarised Azerbaijani translation of the manufacturer's document on test methods, packaging validation, bioburden, pyrogenicity and sterility test results and process validation; the manufacturer's declaration of conformity of manufacture with safety and effectiveness requirements stating the risk degree; a copy of the manufacturer's quality-management-system certificate; the documents required by Articles 18.2.1–18.2.3 of the Law on Licences and Permits; and, for used devices, a copy of the manufacturer's serviceability document. Items §4.2.1, §4.2.2, §4.2.8 and §4.2.9 do not apply to devices manufactured in Azerbaijan.

Conditions
  • Only §§4.2.1, 4.2.2, 4.2.8 and 4.2.9 are waived for Azerbaijani-manufactured devices; §4.2.5 is waived for devices used to obtain information by in-vitro examination of samples taken from the human body; §4.2.6 is waived for devices that do not contact the body of the intended user.
  • The application form is Annex No. 1 to the Rules.
  • Where the Center already holds documents or information under §3.6, they are obtained by the Center rather than re-submitted (§4.5).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim extract: "4.2.1. tibb vasitəsinin istehsalçısının istehsal hüququnu təsdiq edən sənədin və onun əlavəsinin surəti; ... 4.2.8. istehsalçı tərəfindən verilmiş risk dərəcəsi göstərilməklə tibb vasitəsinin istehsalının təhlükəsizlik və effektivlik tələblərinə uyğunluq bəyannaməsi; 4.2.9. istehsalçı tərəfindən verilmiş tibb vasitəsinin istehsalının keyfiyyəti idarəetmə sistemi üzrə sertifikatın surəti; ... 4.3. Bu Qaydaların 4.2.1-ci, 4.2.2-ci, 4.2.8-ci və 4.2.9-cu yarımbəndləri Azərbaycan Respublikasında istehsal olunan tibb vasitələrinə münasibətdə, 4.2.5-ci yarımbəndi insan orqanizmindən alınan nümunələrin sınaq şüşəsində müayinəsi yolu ilə məlumatın alınması üçün istifadə edilən tibb vasitələrinə münasibətdə, 4.2.6-cı yarımbəndi isə tətbiqi nəzərdə tutulan insanın bədəni ilə təmasda olmayan tibb vasitələrinə münasibətdə tətbiq edilmir." Translation of §4.3: "The sub-paragraphs §4.2.1, §4.2.2, §4.2.8 and §4.2.9 of these Rules shall not apply to medical devices manufactured in the Republic of Azerbaijan; sub-paragraph §4.2.5 shall not apply to medical devices used to obtain information by in-vitro examination of samples taken from the human body; and sub-paragraph §4.2.6 shall not apply to medical devices that do not come into contact with the body of the intended user."

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Who may apply: manufacturer, wholesale pharmaceutical enterprise, any legal person or sole trader, or the Ministry

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The applicant ('ərizəçi') for device registration may be the inventor, the manufacturer, a wholesale pharmaceutical enterprise, or the Ministry of Health itself; and, for medical devices, also a legal person or individual entrepreneur that is neither a manufacturer of medicinal products nor a wholesale pharmaceutical enterprise. The applicant therefore does not have to be the manufacturer, so a locally established legal person or sole trader can file for a foreign manufacturer.

Conditions
  • The rules do not require the applicant to hold a manufacturing or wholesale-pharmaceutical licence where it is applying for a medical device as a legal person or individual entrepreneur.
  • The applicant must pay the state duty within 5 working days of the Center's notification (§6.16).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §2.1.1 (line breaks removed): "2.1.1 ərizəçi – Qanunun 6.1-ci və 9.5-ci maddələrinə əsasən dərman vasitələrinin, dərman maddələrinin və tibb vasitələrinin dövlət qeydiyyatına (yenidən dövlət qeydiyyatına) alınması və ya qeydiyyat sənədlərində edilən dəyişikliklərin qeydiyyata alınması üçün müraciət edən dərman vasitələrinin, dərman maddələrinin və tibb vasitələrinin ixtiraçısı, istehsalçısı, topdansatış əczaçılıq müəssisəsi və ya Azərbaycan Respublikasının Səhiyyə Nazirliyi, həmçinin tibb vasitələrinin dövlət qeydiyyatına (yenidən dövlət qeydiyyatına) alınması və ya qeydiyyat sənədlərində edilən dəyişikliklərin qeydiyyata alınması üçün müraciət edən dərman vasitələrinin istehsalçısı və ya topdansatış əczaçılıq müəssisəsi olmayan hüquqi şəxs və ya fərdi sahibkar;" Translation: "2.1.1 applicant — under Articles 6.1 and 9.5 of the Law, the inventor, manufacturer, wholesale pharmaceutical enterprise or the Ministry of Health of the Republic of Azerbaijan that applies for state registration (re-registration) of medicinal products, medicinal substances and medical devices or for registration of changes made to registration documents, and also a legal person or individual entrepreneur that is not a manufacturer of medicinal products or a wholesale pharmaceutical enterprise and that applies for state registration (re-registration) of medical devices or for registration of changes made to registration documents;".

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Import of a medical device into Azerbaijan requires an import authorisation supported by proof of rights over the storage premises, a notarised purchase contract, batch quality documents and a certificate of origin

establishment.device-import-authorisation-and-storage-premises
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Import of a medical device into Azerbaijan is an authorisation, not a notification. Article 9-1.9 of the Law on Medicinal Products sets a device-specific document set: where medical devices are imported, the following documents are added to the application — (9-1.9.1) a copy of the extract from the state register of legal persons where the applicant is a legal person, or a copy of the identity document where the applicant is an individual entrepreneur; (9-1.9.2) a copy of the certificate of registration of the applicant as a taxpayer; (9-1.9.3) a copy of the document confirming the applicant's right of ownership, use or lease over the facilities (warehouses, sites) at which the import of the medical devices named in the application will be carried out; (9-1.9.4) a notarised copy of the sale-purchase contract for the imported medical devices (and, where the contract is in a foreign language, also its notarised translation into Azerbaijani); (9-1.9.5) a copy of the paper and electronic invoice (and, where the invoice does not reflect them, also the information provided by the manufacturer (seller) on the full name, serial number and service life or shelf life of each imported medical device); (9-1.9.6) a copy of the document reflecting the results of the manufacturer's quality indicators confirming that each batch of devices conforms to its specification; (9-1.9.7) a copy of the certificate of origin. Used medical devices additionally require the manufacturer's (seller's) document on their serviceability (article 9-1.10). Article 9-1.12 requires the authorising body to decide, in respect of medical devices, within the period set by article 19.9 of the Law on Licences and Permits (23 working days, or 13 on a simplified expertise, is the period for medicinal products). A local storage or handling establishment is therefore a precondition of the import authorisation, evidenced by a right of ownership, use or lease over the warehouse or site. The pharmaceutical-activity licensing regime of article 5 (manufacture, wholesale and retail of medicinal products) is not a device requirement: article 1-1 excludes article 5 from the device-equivalence clause, and the device document set in article 9-1.9 contains no wholesale pharmacy licence, in contrast with the licence required for medicinal products by article 9-1.5.3.

Conditions
  • The establishment hook is documentary: article 9-1.9.3 requires proof of the applicant's right of ownership, use or lease over the facilities at which the imported devices will be handled, but the Law does not create a separate device wholesale or distribution licence.
  • The bounded claim about article 5 rests on the device-equivalence clause of article 1-1, which lists article 5 among the provisions excluded from the deeming, read together with the absence of any licence requirement in the device document set of article 9-1.9.
  • Articles 9-1.16 (refusal grounds, including the state-register requirement of 9-1.16.2) and 9-1.17 (reasoned refusal, administrative and judicial appeal) are written for 'dərman vasitələrinin idxalına icazə'; because article 1-1 carves article 9-1 out of the device-equivalence clause, their application to device import authorisations is by analogy, not express words.
  • The application is filed with the authorising body (icazə verən orqan) as defined in article 1.0.37.

Source language is Azerbaijani; passages are quoted in the original with an English translation. Retrieved 2026-09-16 over direct HTTPS from the National Legal Information System's generated PDF of the consolidated Law on Medicinal Products No. 208-IIIQ (HTTP 200, application/pdf, 461270 bytes).

Fees

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

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Expertise of drug-containing devices by the Analytical Expertise Centre is paid under a contract within five working days of the Centre's notice; the price is not refunded if the expertise is halted for uncured deficiencies

fees.aem-expertise-contract-price-for-drug-containing-devices
Fact-level verified

For a device made in a dosed pharmaceutical form from natural or synthetic substances and containing a medicinal substance, the Analytical Expertise Centre conducts the expertise within 30 calendar days; if the application and documents show no deficiencies the Centre sends the applicant, within 5 working days, a written or electronic notice and a contract form, and the applicant must pay the expertise price under the contract to the Centre's bank account within 5 working days. If the applicant does not cure identified errors or supply the additional information within the 10-calendar-day period, the expertise is halted and neither the samples nor the contract price are returned.

Conditions
  • Applies only to the drug-containing device category defined in CM 345 §4.4 and CM 502 §6-1.1; other devices are registered by the Ministry of Health without Analytical Expertise Centre expertise and pay only the state duty.
  • The contract price is not stated in the Rules; the Tariff Council's published tariff for the Centre lists medicinal-product and medicinal-substance expertise only (see fees.tariff-council-expertise-tariffs-list-no-device-line).

English gist as in value. Section 6-1 was added to the CM 502 Rules by a later amending decision (endnote [64] of the consolidated text); its commencement date was not extracted.

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 must be paid within 5 working days of the Center's notification

fees.state-duty-payment-window
Fact-level verified

For state registration, re-registration or registration of a change to the registration documents of a medical device, the applicant must pay the state duty under the Law of the Republic of Azerbaijan 'On State Duty' within 5 (five) working days after receiving the notification from the Analytical Expertise Center. A duplicate certificate issued on loss or damage of the original does not attract a state duty.

Conditions
  • The Rules fix only the payment window, not the amount; no medical-device state-duty or expertise tariff has been published by the Tariff Council.
  • No state duty is charged for a duplicate registration certificate (§6.14).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §6.16 (line breaks removed): "6.16. Dərman vasitəsinin, dərman maddəsinin və ya tibb vasitəsinin dövlət qeydiyyatına (yenidən dövlət qeydiyyatına), onların qeydiyyat sənədlərində edilən dəyişikliklərin dövlət qeydiyyatına alınması üçün ərizəçi Qanunun 1-1-ci və 6.10-cu maddələrinə əsasən, Qurum tərəfindən bildirişi aldıqdan sonra 5 (beş) iş günü müddətində “Dövlət rüsumu haqqında” Azərbaycan Respublikasının Qanununa uyğun olaraq dövlət rüsumunu ödəməlidir." Translation: "6.16. For state registration (re-registration) of a medicinal product, medicinal substance or medical device, and for state registration of changes made to their registration documents, the applicant must, under Articles 1-1 and 6.10 of the Law, pay the state duty in accordance with the Law of the Republic of Azerbaijan 'On State Duty' within 5 (five) working days after receiving the notification from the Center." The amount is not stated in this instrument.

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.

Label, IFU & language

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

Compare countries

Azerbaijani-language labelling content and notarised IFU translation

label.azerbaijani-language-packaging-and-ifu
Fact-level verified

The dossier must carry the manufacturer's labelling and packaging information, including colour mock-ups of the packaging and labels and their content in the Azerbaijani language. The instructions for use of a medical device containing a medicinal substance must be supplied by the applicant as a notarially certified translation into Azerbaijani, checked by the Analytical Expertise Center and approved by the Ministry; the approved instructions of registered products are published in PDF on the Center's official website.

Conditions
  • The express notarised-IFU-translation duty in §9.1 is written for medicinal products and for medical devices containing a medicinal substance; the general labelling-content duty in §4.2.4 covers medical devices.
  • Approved IFUs are published by the Center, making them public.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §4.2.4: "4.2.4. tibb vasitəsinin istehsalçısı tərəfindən verilmiş tibb vasitəsinin etiketlənməsinə və qablaşdırmasına dair məlumatlar (qablaşdırma və etiketlərin rəngli maketləri, Azərbaycan dilində məzmunu);" Translation: "4.2.4. information provided by the manufacturer of the medical device on the labelling and packaging of the medical device (colour mock-ups of the packaging and labels, their content in the Azerbaijani language);". Verbatim §9.1: "9.1. Dərman vasitəsinin və tərkibində dərman maddəsi olan tibb vasitəsinin istifadə təlimatının Azərbaycan dilində notariat qaydasında tərcüməsi ərizəçi tərəfindən təqdim olunur, Qurum tərəfindən yoxlanılır və Nazirlik tərəfindən təsdiq edilir." Translation: "9.1. A notarially certified translation into the Azerbaijani language of the instructions for use of a medicinal product and of a medical device containing a medicinal substance shall be submitted by the applicant, checked by the Center and approved by the Ministry."

Official forms & portals

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

Compare countries

The official Azerbaijani device registration forms are the application form and the medical-device registration certificate forms annexed to Cabinet Decision No. 345 of 2024

forms.device-expertise-and-registration-application-forms
Fact-level verified

Applications for state registration of a medical device in Azerbaijan are made to the Ministry of Health (Nazirlik) on the application form annexed to the registration Rules as Annex No. 1 (1 nömrəli əlavə) — the same application form the Rules prescribe for medicinal products (Rules 3.2 and 4.2). The device dossier is examined by the 'Analitik Ekspertiza Mərkəzi' public legal entity (Qurum) and the registration certificate for a medical device is issued by the Ministry in the form set out in Annex No. 5 (5 nömrəli əlavə), and, where the data on an issued certificate change, in the form set out in Annex No. 6 (6 nömrəli əlavə). Both device certificate forms are headed 'QEYDİYYAT VƏSİQƏSİ / REGİSTRATİON CERTİFİCATE' and carry the certificate series 'TV №' (tibb vasitəsi), as distinct from the 'DV №' series used for medicinal products in Annexes 2A, 2B, 3A, 3B, 4A and 4B. The forms are annexed to and published with Cabinet Decision No. 345 of 18 July 2024 on the Cabinet's own site, and the same Rules are published in the National Legal Information System as framework 57583. No single online filing portal for device registration is created by these Rules; filing is a paper application to the Ministry on the annexed form.

Conditions
  • The application form is shared with medicinal products: Rules 4.2 introduces the device document set with the words 'bu Qaydaların 1 nömrəli əlavəsi olan ərizə ilə birgə' (together with the application which is Annex No. 1 to these Rules), and that annex is the only application form annexed to the Rules.
  • The certificate forms for devices are Annexes 5 and 6; Annex 5 is the form for an initial registration certificate and Annex 6 the form used where data reflected on the certificate change (Rules 7.1 and 7.2).
  • The registration itself is performed by the Ministry of Health: Rules 1.6 provides that medicinal products, medicinal substances and medical devices are state-registered and entered in the state register by the Ministry of Health, and Rules 10.1 provides that the state register is kept by the Ministry through the Qurum. The State Agency for Antimonopoly and Consumer Market Control appears nowhere in Decision No. 345, in Decision No. 348 or in the Law on Medicinal Products among the bodies that register devices or grant device import authorisations.
  • The Analytical Expertise Center also publishes the same two forms as downloadable .docx files under its medical-devices section (the medical-device expertise application form and the registration application form), the registration application form being the electronic counterpart of Annex No. 1; the instrument itself, not the download index, is the source of record for this refresh.

Source language is Azerbaijani; the passage is quoted in the original with an English translation. Retrieved 2026-09-16 over direct HTTPS from nk.gov.az (HTTP 200, application/pdf, 298568 bytes, Last-Modified Fri, 19 Jul 2024 07:23:58 GMT); the same instrument was confirmed in the National Legal Information System, framework 57583, citation 345, accept date 18.07.2024, status 'Qüvvədədir', register code 14202407180345, published in Xalq Qəzeti 20.07.2024. This fact refreshes the row previously held as source-backed-partial on the strength of the Analytical Expertise Center's website; the instrument itself is now the source of record.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Manufacturer QMS certificate and declaration of conformity required in the dossier

qms.manufacturer-qms-certificate-and-declaration-of-conformity
Fact-level verified

The registration dossier must contain a copy of the manufacturer's quality-management-system certificate for the manufacture of the medical device, and the manufacturer's declaration of conformity of the device's manufacture with safety and effectiveness requirements stating the risk degree. Neither item is required for devices manufactured in Azerbaijan. The rules contain no provision for a regulator audit of the foreign manufacturing site as part of registration.

Conditions
  • The Rules do not specify a recognised QMS standard (e.g. ISO 13485) for this certificate.
  • No on-site inspection of the foreign manufacturing site is provided for in the registration Rules; market surveillance is a separate regime under the Law.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §4.2.8–4.2.9: "4.2.8. istehsalçı tərəfindən verilmiş risk dərəcəsi göstərilməklə tibb vasitəsinin istehsalının təhlükəsizlik və effektivlik tələblərinə uyğunluq bəyannaməsi; 4.2.9. istehsalçı tərəfindən verilmiş tibb vasitəsinin istehsalının keyfiyyəti idarəetmə sistemi üzrə sertifikatın surəti;" Translation: "4.2.8. the manufacturer's declaration of conformity of the manufacture of the medical device with safety and effectiveness requirements, indicating the risk degree; 4.2.9. a copy of the certificate for the quality management system of the manufacture of the medical device issued by the manufacturer;". Verbatim §4.3 (opening): "4.3. Bu Qaydaların 4.2.1-ci, 4.2.2-ci, 4.2.8-ci və 4.2.9-cu yarımbəndləri Azərbaycan Respublikasında istehsal olunan tibb vasitələrinə münasibətdə ... tətbiq edilmir." Translation: "4.3. The sub-paragraphs §4.2.1, §4.2.2, §4.2.8 and §4.2.9 of these Rules shall not apply to medical devices manufactured in the Republic of Azerbaijan...".

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Recall of a registered device follows the Recall Rules (Cabinet Resolution No. 460 of 27 November 2019)

recall.cabinet-resolution-460-procedure
Fact-level verified

Where state registration is suspended, the Ministry takes a decision on the recall of the medicinal products, medicinal substances and medical devices already in circulation in accordance with the 'Rules on the recall of medicinal products' approved by Cabinet of Ministers Resolution No. 460 of 27 November 2019. The Rules themselves set no separate device-specific recall procedure.

Conditions
  • The recall instrument is the medicinal-products recall Rules, applied by §11.2 to medical devices as well.
  • The Rules contain no device field safety corrective action notification duty or reporting timeline.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §11.2 (line breaks removed): "11.2. Dövlət qeydiyyatı dayandırılmış dərman vasitələrinin, dərman maddələrinin və tibb vasitələrinin Azərbaycan Respublikasına idxalı, Azərbaycan Respublikası ərazisində satış üçün istehsalı, satışı və istifadəsi dayandırılır. Dövlət qeydiyyatının dayandırılmasının əsası nəzərə alınaraq, Nazirlik tərəfindən dövriyyədə olan dərman vasitələri, dərman maddələri və tibb vasitələri haqqında geri çağırılma barədə qərar Azərbaycan Respublikası Nazirlər Kabinetinin 2019-cu il 27 noyabr tarixli 460 nömrəli Qərarı ilə təsdiq edilmiş “Dərman vasitələrinin geri çağırılması Qaydası”na əsasən verilir." Translation: "11.2. The import into the Republic of Azerbaijan, manufacture for sale, sale and use in the territory of the Republic of Azerbaijan of medicinal products, medicinal substances and medical devices whose state registration has been suspended shall be stopped. Taking into account the ground for suspension of state registration, a decision on the recall of the medicinal products, medicinal substances and medical devices in circulation shall be taken by the Ministry in accordance with the 'Rules on the recall of medicinal products' approved by Cabinet of Ministers Resolution No. 460 of 27 November 2019."

Registration pathways

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

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Single national registration pathway, limited to higher-than-high, high and/or medium risk devices

pathways.single-national-route-for-higher-high-medium-risk
Fact-level verified

There is one registration pathway for medical devices: application to the Ministry of Health, expertise by the Analytical Expertise Center, and issue of a registration certificate by the Ministry. It applies only to devices classified as higher-than-high, high and/or medium risk; devices below that threshold are outside the state registration requirement.

Conditions
  • No abridged, recognition, verification or notification pathway exists for devices.
  • A device consisting of natural or synthetic substances and their compounds in a pharmaceutical form with a defined dose that contains information on a medicinal substance must additionally have that substance examined before registration, under Resolution No. 502 (§4.4).
  • Non-separable accessories are registered with the device as a set, not separately (§7.10).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §1.2.3: "1.2.3. risk dərəcəsi daha yüksək, yüksək və (və ya) orta olan tibb vasitələri." Translation: "1.2.3. medical devices with a higher, high and (or) medium risk degree." Verbatim §7.1 (opening): "7.1. Təqdim edilən sənədlərdə çatışmazlıq olmadığı halda ərizəçi tərəfindən Nazirliyə həmin sənədlərin təqdim edildiyi gündən 7 (yeddi) iş günü müddətində ... Nazirlik tərəfindən qeydiyyat vəsiqəsi verilir." Translation: "7.1. In the absence of deficiencies in the submitted documents, a registration certificate shall be issued by the Ministry within 7 (seven) working days from the day the applicant submitted those documents to the Ministry...".

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Azerbaijan 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 Azerbaijan (6 records)

AzerbaijanEurasian Economic Union (EAEU)

Prior approval / evidence record

EAEU marketing authorisation

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.

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

AzerbaijanSource authority not specified

Prior approval / evidence record

Origin-country registration document or free-sale/export certificate is a mandatory dossier item (evidentiary only)

reliance.origin-country-registration-or-free-sale-certificate
Fact-level verified
Statement

Every medical-device registration dossier must contain, with a notarially certified translation into Azerbaijani, any one of: (a) a document confirming state registration of the device in the country where it is manufactured, or — where it is not registered there — a document (documents) confirming state registration in another country or countries; or (b) the device's free-sale or export certificate, where one exists. The item is mandatory paperwork for the national expertise; it creates no shortened route and does not by itself establish a right to market.

Source Approval

Any country's national device registration certificate; or a free-sale / export certificate issued for the device

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The dossier item is satisfied by either sub-item — a free-sale/export certificate can stand in place of a foreign registration document, and the Rules mark it '(olduqda)' (where one exists).
  • The document must be translated into Azerbaijani with notarial certification.
  • For a device with a medicinal substance, a further item on the substance is required (§4.2.5), and the registration dossier must also show its registration in any country (see the Resolution No. 502 amendment of 20 July 2024).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §4.2.2–4.2.2.2 (line breaks removed): "4.2.2. aşağıda qeyd edilmiş sənədlərdən hər hansı birinin notariat qaydasında Azərbaycan dilinə tərcümə edilmiş surəti: 4.2.2.1. tibb vasitəsinin istehsal olunduğu ölkədə dövlət qeydiyyatına alınmasını təsdiq edən sənəd, həmin ölkədə dövlət qeydiyyatına alınmadığı təqdirdə isə digər ölkədə (ölkələrdə) dövlət qeydiyyatına alınmasını təsdiq edən sənəd (sənədlər); 4.2.2.2. tibb vasitəsinin azad satış və ya ixrac üzrə sertifikat (olduqda);" Translation: "4.2.2. a copy, translated into Azerbaijani with notarial certification, of any one of the documents listed below: 4.2.2.1. a document confirming state registration of the medical device in the country where it is manufactured, or, where it is not state-registered in that country, a document (documents) confirming state registration in another country (countries); 4.2.2.2. the free-sale or export certificate of the medical device (where one exists);". The source names no specific foreign authority, so the fact is written as an origin-country evidence rule, not as recognition of FDA or CE.

Prior approval / evidence record

MDSAP

Authority

MDSAP

Accepted

No

Benefit

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

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

Prior approval / evidence record

US FDA 510(k)/PMA

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.

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

AzerbaijanSource authority not specified

Prior approval / evidence record

No foreign-approval recognition route for medical devices — foreign registration recognition is a medicinal-product mechanism only

reliance.no-device-recognition-route
Fact-level verified
Statement

Azerbaijan operates no recognition, abridged or fast-track route for medical devices. The foreign (international) registration recognition mechanism in the Cabinet's registration Rules is expressly confined to medicinal products ('dərman vasitəsi') under Article 6-2 of the Law on Medicinal Products, and paragraph 1.3 subjects only medicinal products and medicinal substances to the simplified-expertise procedure of Resolution No. 502. A medical device is registered solely through the full national dossier and expertise in Part 4 of the Rules, whatever FDA, CE, PMDA or MFDS approval the device holds.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Paragraph 1.7 recognition applies only to a dərman vasitəsi (medicinal product) — medical devices are excluded from its scope.
  • The mechanism it names is recognition of registration in the countries on the list approved by Cabinet Resolution No. 480 of 26 December 2023; that list is not applied to devices by these Rules.
  • Full national expertise by the Analytical Expertise Center and a Ministry of Health registration certificate are required in every case.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §1.7 (line breaks removed): "1.7. Azərbaycan Respublikası Nazirlər Kabinetinin 2023-cü il 26 dekabr tarixli 480 nömrəli Qərarı ilə təsdiq edilmiş “Dərman vasitəsinin xarici (beynəlxalq) qeydiyyatının tanınması şamil olunan ölkələrin və xarici (beynəlxalq) təşkilatların siyahısı”nda qeyd edilən ölkələrin azı birində istehsal olunmuş, dövlət qeydiyyatına alınmış və satışına icazə verilmiş və ya xarici (beynəlxalq) təşkilatlar tərəfindən istifadəsinə icazə verilmiş, həmçinin digər ölkələrdə istehsal olunmuş və həmin siyahıda olan ölkələrin azı ikisində dövlət qeydiyyatına alınmış və bu ölkələrdə satışına icazə verilmiş dərman vasitəsinin xarici (beynəlxalq) qeydiyyatının tanınması və dövlət reyestrinin aparılması qaydası Qanunun 6-2-ci maddəsinə uyğun olaraq həyata keçirilir." Translation: "Recognition of the foreign (international) registration of a medicinal product that was manufactured in at least one of the countries listed in the 'List of countries and foreign (international) organisations to which recognition of the foreign (international) registration of a medicinal product applies', approved by Cabinet of Ministers Resolution No. 480 of 26 December 2023, has been state-registered and authorised for sale there, or has been authorised for use by foreign (international) organisations, and also of a medicinal product manufactured in other countries and state-registered in at least two of the countries on that list and authorised for sale in those countries, and the maintenance of the state register shall be carried out in accordance with Article 6-2 of the Law." The subject of the paragraph is 'dərman vasitəsi' (medicinal product) throughout; 'tibb vasitəsi' (medical device) is a separately defined term used elsewhere in the same instrument.

AzerbaijanEU conformity assessment

Prior approval / evidence record

EU CE marking under MDR/IVDR

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.

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

Review clocks

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

Compare countries

Review clocks: 7 working days to issue, 5 to notify deficiencies, 10 to cure

clocks.seven-day-decision-five-day-deficiency-notice
Fact-level verified

Where the submitted documents are free of deficiencies, the Ministry issues the registration certificate within 7 (seven) working days of submission (or of the expertise opinion reaching the Ministry for devices under §4.4). Where curable deficiencies are found, the Ministry notifies the applicant no later than 5 (five) working days from the date the application was registered; the applicant must cure them within 10 (ten) working days, during which the clock stops. The statutory expert-examination periods are excluded from the Ministry's review clock.

Conditions
  • Clocks run in working days.
  • The 7-working-day clock is the Ministry's, not the Analytical Expertise Center's; the Center's expertise time is largely excluded (§7.12).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §7.3 (opening): "7.3. Ərizədə və ona əlavə edilmiş sənədlərdə aradan qaldırılması mümkün olan və qeydiyyat vəsiqəsinin verilməsindən imtinaya səbəb olmayan çatışmazlıqlar aşkar edildikdə, ərizənin qeydiyyata alındığı tarixdən 5 (beş) iş günündən gec olmayaraq Nazirlik onların aradan qaldırılması barədə məlumatı ərizəçiyə təqdim edir..." Translation: "7.3. Where deficiencies that can be removed and that do not cause refusal to issue the registration certificate are found in the application and the documents attached to it, the Ministry shall, no later than 5 (five) working days from the date the application was registered, provide the applicant with information on their removal...". Verbatim §7.4 (opening): "7.4. Ərizəçi həmin çatışmazlıqlar barədə məlumatı aldığı vaxtdan ən geci 10 (on) iş günü müddətində aradan qaldırmalıdır." Translation: "7.4. The applicant must remove those deficiencies within no more than 10 (ten) working days from the time of receiving the information about them." Verbatim §7.12: "7.12. Ərizəçinin tibb vasitəsinə verilən qeydiyyat vəsiqəsinin alınması üçün müraciətinə baxılması müddətinə bu Qaydaların 4.4-cü bəndində göstərilən dərman maddələrinin Qanunla müəyyən edilmiş ekspertizası müddətləri daxil edilmir." Translation: "7.12. The periods of expertise of medicinal substances established by the Law, indicated in §4.4 of these Rules, are not included in the period for consideration of the applicant's application for a registration certificate issued for a medical device."

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Exhibition samples require four supporting documents and return within 14 calendar days after the exhibition ends

derogation.temporary-import-for-exhibition
Fact-level verified

Article 9-1.7 of the Law on Medicinal Products names medical devices expressly: where medicinal products and/or medical devices, as well as medicinal substances, intended to be displayed at an exhibition are temporarily imported, the following documents are added to the application: (9-1.7.1) where the applicant is a legal person, a copy of the extract from the state register of legal persons, and where the applicant is an individual entrepreneur, a copy of the identity document; (9-1.7.2) a copy of the certificate of registration of the applicant as a taxpayer; (9-1.7.3) a copy of the invoice; (9-1.7.4) a copy of the letter (document) of the exhibition organiser recording the applicant participating in the exhibition and the samples the applicant will display. Article 9-1.8 provides that the samples of medicinal products and/or medical devices, as well as medicinal substances, temporarily imported for display at an exhibition are returned within no later than 14 (fourteen) calendar days after the exhibition ends; those samples may not be sold, and their packaging must carry the words 'Nümunədir, satıla bilməz.' Article 9-1.16.2, written for medicinal products ('dərman vasitələri'), lists products intended for display at an exhibition among the exceptions to the requirement that an imported product be entered in the state register; its extension to devices is by analogy with 9-1.7 and 9-1.8 rather than by express words.

Conditions
  • The exhibition route is an import-authorisation application under article 9-1, not a separate registration procedure; the 14-calendar-day return clock in article 9-1.8 is the operative limit on the samples' presence in the country.
  • Sale of the samples is prohibited by article 9-1.8 itself, and the packaging must be marked 'Nümunədir, satıla bilməz.'
  • The application is filed with the authorising body (icazə verən orqan), defined in article 1.0.37 as the body designated by the relevant executive authority that performs state registration and grants import authorisations.
  • Article 1-1 lists article 9-1 among the provisions excluded from the device-equivalence clause; articles 9-1.7, 9-1.8, 9-1.9 and 9-1.10 reach medical devices through their own express words, whereas 9-1.11 to 9-1.18 speak only of medicinal products.

Source language is Azerbaijani; the passage is quoted in the original with an English translation. Retrieved 2026-09-16 over direct HTTPS from the National Legal Information System's generated PDF of the consolidated Law (HTTP 200, application/pdf, 461270 bytes, produced by wkhtmltopdf). This replaces the Analytical Expertise Center's republication of the same provisions, which was the source of the previous source-backed-partial row and which is not the gazette text; the row's own condition flagged that limitation, and it is now discharged against the official consolidated text.

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.

CM 345 §4.4: a device in a dosed pharmaceutical form whose registration documents disclose a medicinal substance must be examined by the Analytical Expertise Centre under the CM 502 Rules before registration

testing.cm345-expertise-trigger-for-drug-containing-devices
Fact-level verified

Where the documents submitted for state registration of a device made from natural or synthetic substances and their compounds in a dosed pharmaceutical form contain information about a medicinal substance, the device must, before state registration, be examined by the Analytical Expertise Centre to establish the quality, efficacy and safety of the medicinal substances it contains; the expertise is carried out under the Rules approved by Cabinet Decision No. 502 of 25 December 2019.

Conditions
  • All other devices (higher, high and medium risk under Art. 1.0.8 of the Law) are registered on documents alone under §4.2 without Centre expertise; low-risk devices are outside state registration.

Effective from 2024-07-18

English gist as in value. 'Qurum' is defined in §4.4 itself as the public legal entity 'Analitik Ekspertiza Mərkəzi'.

Drug-containing devices in a dosed pharmaceutical form undergo documentary expertise and laboratory analysis of samples by the Analytical Expertise Centre before registration, with a per-batch certificate of analysis and three samples

testing.laboratory-analysis-of-drug-containing-devices-before-registration
Fact-level verified

Before state registration of a device made from natural or synthetic substances and their compounds in a dosed pharmaceutical form, the Analytical Expertise Centre carries out an expertise of the documents and laboratory analyses of product samples to establish the quality, efficacy and safety of the medicinal substance it contains. The applicant must submit with the application the packaging artwork, the instructions for use with a notarised Azerbaijani translation, the manufacturer's composition document with quantities and a notarised translation, the device's certificate of analysis for each batch including the analytical methods, proof of registration in any country (except for devices made in Azerbaijan) and three samples of the device.

Conditions
  • Trigger is CM 345 §4.4: where the documents filed for registration of such a device disclose a medicinal substance, expertise by the Centre under the CM 502 Rules is mandatory before registration.
  • Under CM 502 §6-1.3, if the dose of the medicinal substance equals or exceeds that of a medicinal product or substance, the product must instead be registered as a medicinal product or substance.
  • Deficiency loop: the Centre notifies inconsistencies in writing within 5 working days and the applicant has 10 calendar days to cure them, during which the expertise clock stops (§6-1.5–6-1.6).

English gist as in value. The same section 6-1 text is reproduced on the Analytical Expertise Centre's 'TV sənədlər' page (pharma.az), already a registry source.

Sterile devices: test-method, packaging-validation, bioburden, pyrogenicity and sterility evidence

testing.sterile-device-package-and-sterility-validation
Fact-level verified

For sterile medical devices the dossier must include a notarially certified Azerbaijani translation of a manufacturer's document reflecting: the methods of conducting tests and the validation of packaging; test results for microbiological content (degree of bioburden), pyrogenicity and sterility; and data on process validation. The manufacturer's biological safety information is required for every device that contacts the intended user's body (waived for non-contacting devices).

Conditions
  • No separate Azerbaijani standards or national testing requirement is imposed by the Rules; the evidence is the manufacturer's own validation and test documentation.
  • Biological safety data is waived only for devices that do not contact the intended human body (§4.3).

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §4.2.7 (line breaks removed): "4.2.7. steril tibb vasitələrinə münasibətdə sınaqların aparılma üsullarının və qablaşdırmanın validasiyasına dair məlumatları, mikroorqanizmləri ehtiva etməsinə (bioloji yüklənmə dərəcəsi), pirogenliyə və sterilliyə görə test nəticələri və prosesin validasiyasına dair məlumatları əks etdirən istehsalçı tərəfindən verilən sənədin notariat qaydasında Azərbaycan dilinə tərcümə edilmiş surəti;" Translation: "4.2.7. for sterile medical devices, a copy, translated into Azerbaijani with notarial certification, of the document issued by the manufacturer reflecting information on the methods of conducting tests and the validation of packaging, test results for microbiological content (degree of bioburden), pyrogenicity and sterility, and information on process validation;". Verbatim §4.2.6: "4.2.6. istehsalçı tərəfindən verilmiş bioloji təhlükəsizliyə dair məlumatlar;" Translation: "4.2.6. biological safety information issued by the manufacturer;".

Submission communications & appeal

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

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Deficiency procedure, unexamined-application act, and grounds of refusal

submission.deficiency-unexamined-status-and-refusal-grounds
Fact-level verified

If the applicant does not cure the notified deficiencies within 10 working days, the Ministry adopts an administrative act leaving the application unexamined and informs the applicant within 2 (two) working days, by delivery or registered post (§7.5). After curing the deficiencies the applicant may apply again with a fresh application for the registration certificate (§7.6). Registration, re-registration and variation applications are refused where the Part 3/Part 4 documents are not submitted in full and the deficiency is not cured under Article 52 of the Law on Administrative Proceedings (§5.1.1), where information submitted is found to be untrue (§5.1.2), and, for a medical device, where an inconsistency is found in the submitted documents concerning the device's quality, effectiveness and safety (§5.1.4); a refusal decision is notified to the applicant by registered post within 2 working days (§5.2).

Conditions
  • All deficiencies are notified to the applicant at one time (§7.3).
  • The legal consequences of non-compliance with formal requirements must be explained to the applicant (§7.3).
  • §5.1.3 (negative expert opinion) is written for medicinal products and substances only.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §7.5 (line breaks removed): "7.5. Ərizəçi ərizədə və ona əlavə edilmiş sənədlərdə aşkar olunmuş çatışmazlıqları bu Qaydaların 7.4-cü bəndində göstərilən müddətdə aradan qaldırmadıqda, Nazirlik ərizənin baxılmamış saxlanılması haqqında inzibati akt qəbul edir və bu barədə məlumatı 2 (iki) iş günü müddətində ərizəçiyə təqdim edir və ya sifarişli poçt göndərişi vasitəsilə göndərir." Translation: "7.5. Where the applicant does not remove the deficiencies found in the application and the documents attached to it within the period indicated in §7.4 of these Rules, the Ministry shall adopt an administrative act on leaving the application unexamined and shall, within 2 (two) working days, deliver information about this to the applicant or send it by registered post." Verbatim §7.6: "7.6. Ərizəçi aşkar olunmuş çatışmazlıqları aradan qaldırdıqdan sonra qeydiyyat vəsiqəsinin alınması üçün təkrar ərizə ilə Nazirliyə müraciət edə bilər." Translation: "7.6. After removing the deficiencies found, the applicant may apply to the Ministry with a repeated application to obtain the registration certificate." Verbatim §5.1.2: "5.1.2. təqdim edilmiş sənədlərdə həqiqətə uyğun olmayan məlumatlar aşkar edildikdə;" Translation: "5.1.2. where information that is not true is found in the submitted documents;".

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Azerbaijan identifies registered medical devices by GMDN code and carries their data, including a global identification number where one exists, in the state track-and-trace system

traceability.state-track-and-trace-device-module-and-gmdn-code
Fact-level verified

Azerbaijan's device identification obligation runs on two rails, neither of which is a UDI-issuing-entity regime. First, the registration Rules require the device's GMDN code in the state register: article 10.4 of the Rules lists the data entered in the state register in respect of medical devices — the device's trade name (10.4.1), type (10.4.2), risk degree (10.4.3), description of the primary and/or secondary packaging (10.4.4), accessories (10.4.5), the GMDN code (10.4.6), and where the device contains a medicinal substance, information on the active substance and its dose (10.4.7) — and article 2.1.2 defines 'tibb vasitələrinin qlobal nomenklaturası (TVQN)' as the international system of codes and terms adopted for the purpose of identifying medical devices. Second, the Regulation on the Track-and-Trace System for Medicinal Products approved by Cabinet Decision No. 348 of 20 July 2024 constitutes a 'Tibb vasitələri və Dərman maddələri' (Medical devices and medicinal substances) module within the state track-and-trace system (articles 4.1.2 and 4.2.2), whose data fields for a device include its trade name (4.2.2.1), type (4.2.2.2), risk degree (4.2.2.3), primary and/or secondary packaging description (4.2.2.4), accessories (4.2.2.5), any medicinal substance contained and its active substance and dose (4.2.2.6), pack size (4.2.2.7), manufacturer (4.2.2.8), country of manufacture (4.2.2.9), the dates of entry in the state register and of expiry of the state registration together with the registration certificate's number and date and the Azerbaijani-alphabet trade name on the certificate (4.2.2.10), and the device's global identification number where available (4.2.2.11). The system is owned by the Ministry of Health and operated by the Analytical Expertise Centre (articles 2.1.3 and 2.1.4), is free to use (article 1.7), and its purpose is control of the import and circulation of the products it covers (article 1.2).

Conditions
  • The global identification number is qualified by the words 'olduğu halda' ('where available'), so its provision is conditional and the Regulation does not itself create an obligation to obtain one.
  • The instrument carrying the module is titled for medicinal products and its system is defined in article 1.0.35 of the Law on Medicinal Products; the device reach rests on the module's express terms in articles 4.1.2 and 4.2.2, which are written for medical devices, and on the device data fields 4.2.2.1-4.2.2.11.
  • The state-register GMDN field is device-specific: article 10.2 applies the medicinal-product register fields to medicinal products, article 10.3 the medicinal-substance fields, and article 10.4 the device fields, of which 10.4.6 is the GMDN code.
  • The registration certificate form for a medical device (Annex No. 5 to the Rules) carries the device's trade name, accessories, risk degree and type, but not a GMDN field; the GMDN code is a state-register field.

Sources are in Azerbaijani; passages are quoted in the original with an English translation. Decision No. 348 retrieved 2026-09-16 over direct HTTPS from nk.gov.az (HTTP 200, application/pdf, 213906 bytes); Decision No. 345 retrieved 2026-09-16 over direct HTTPS from nk.gov.az (HTTP 200, application/pdf, 298568 bytes) and confirmed in the National Legal Information System as framework 57583.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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Grounds on which the Ministry suspends a device registration

vigilance.suspension-grounds
Fact-level verified

The Ministry suspends the state registration of a registered medical device where, apart from the cases in Article 25 of the Law on Licences and Permits, it is established that: the benefit/risk assessment under the Pharmacovigilance Rules (Cabinet Resolution No. 503 of 25 December 2019) shows the therapeutic efficacy to be absent or insufficient; packaging and labelling requirements are not complied with after an official warning from the Analytical Expertise Center has been disregarded; or substantiated facts establishing that the registered product is not quality, effective and safe lead to a decision prohibiting its use in Azerbaijan. Suspension stops import, manufacture for sale, sale and use, and a recall decision is then taken under the Recall Rules approved by Cabinet Resolution No. 460 of 27 November 2019.

Conditions
  • The suspension grounds in §11.1 are drafted around medicinal products (the efficacy ground in §11.1.2 speaks of the therapeutic efficacy of a medicinal product or substance); §11.2 nevertheless states the consequences for medical devices as well.
  • Suspension lasts until the grounds are removed (§11.4) and is published in the press under Article 16 of the Law.

Effective from 2024-07-18

Source language: Azerbaijani. Verbatim §11.1.2 (line breaks removed): "11.1.2. Azərbaycan Respublikası Nazirlər Kabinetinin 2019-cu il 25 dekabr tarixli 503 nömrəli Qərarı ilə təsdiq edilmiş “Dərman vasitələrinin farmakonəzarət Qaydası”na ... əsasən fayda/risk nisbətinin qiymətləndirilməsi nəticəsində dərman vasitəsinin və dərman maddəsinin terapevtik effektivliyinin olmaması və ya kifayət qədər olmaması müəyyən edildikdə;" Translation: "11.1.2. where, as a result of the benefit/risk assessment under the 'Pharmacovigilance Rules for Medicinal Products' approved by Cabinet of Ministers Resolution No. 503 of 25 December 2019, it is established that the therapeutic efficacy of the medicinal product and medicinal substance is absent or insufficient;". Verbatim §11.3: "11.3. Dövlət qeydiyyatı dayandırıldığı halda Nazirlik tərəfindən müvafiq qərar qəbul edildikdə vəsiqə sahibinə bu barədə dərhal yazılı məlumat göndərilir." Translation: "11.3. Where state registration is suspended and the Ministry adopts the relevant decision, written information about this shall be sent to the certificate holder immediately."

Related structured datasets

Classification systems · 1 record
Open Ministry of Health risk degrees — sinif 1, sinif 2a, sinif 2b, sinif 3
Id

azerbaijan:medical-device

Jurisdiction Id

azerbaijan

Domains
  • medical-device
Name

Ministry of Health risk degrees — sinif 1, sinif 2a, sinif 2b, sinif 3

Description

Azerbaijan classifies medical devices by the degree of potential risk associated with their application into four degrees: sinif 1 (low), sinif 2a (medium), sinif 2b (high) and sinif 3 (higher). The scale is set by Ministry of Health Collegium Decision No. 8 of 21 May 2024, §3.3, with the criteria in §3.1 and the allocation rules in Sections 4-6 and 8; Section 7 of the same classification allocates in vitro diagnostic devices to the same four degrees. Only the three higher degrees are state-registered: §3.4 of Decision No. 8 and §1.2.3/§4.2 of Cabinet Resolution No. 345 confine registration to devices whose risk degree is higher, high or medium, so a class 1 device sits outside the registration regime.

Classes
  • Id

    1

    Label

    Sinif 1 — low risk degree (aşağı)

    Normalized Risk Level

    low

  • Id

    2a

    Label

    Sinif 2a — medium risk degree (orta)

    Normalized Risk Level

    medium

  • Id

    2b

    Label

    Sinif 2b — high risk degree (yüksək)

    Normalized Risk Level

    high

  • Id

    3

    Label

    Sinif 3 — higher risk degree (daha yüksək)

    Normalized Risk Level

    highest

Regulator

Ministry of Health of the Republic of Azerbaijan

Official Domains
  • e-qanun.az
  • nk.gov.az
  • pharma.az
  • sehiyye.gov.az
Source Status

official-source-verified

Reference Sources
  • Title

    Cabinet Resolution No. 345 of 18 July 2024 approving the Rules for the state registration and re-registration of medicinal products, medicinal substances and medical devices, §1.2.3 and §3.4

    Url

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

    Reviewed On

    2026-09-16

    Supports

    §1.2.3 places only devices of increased, high and medium risk within the Rules, and §3.4 states that devices of those risk degrees are subject to state registration — the administrative consequence that makes the class axis operative in Azerbaijan and the reason a class 1 device is not registered.

  • Title

    Ministry of Health Collegium Decision No. 7 of 21 May 2024 approving the list of medical devices of increased, high and medium risk degree

    Url

    https://e-qanun.az/frameworks/56/f_56983.html

    Reviewed On

    2026-09-16

    Supports

    The companion list that names which devices fall inside the registerable risk degrees; it is the document an applicant consults to decide whether a device is registrable and in which degree.

  • Title

    Cabinet Resolution No. 345 of 18 July 2024, §10.1 and §10.4 — the state register of registered medical devices

    Url

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

    Reviewed On

    2026-09-16

    Supports

    The same instrument as registered on the legal portal (citation 345, adopted 18.07.2024, in force 19.07.2024, register code 14202407180345), used to corroborate the identity and in-force status of the text read from the Ministry-linked PDF; §10.1 keeps the state register current through the Analytical Expertise Center.

Source Title

Ministry of Health Collegium Decision No. 8 of 21 May 2024 approving the classification of medical devices by risk degree, §3.3 and §3.4

Source Url

https://e-qanun.az/frameworks/56/f_56982.html

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
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

No maintained record.

Additional certifications and licences · 1 record
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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