Azerbaijan medical device regulatory resources

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

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 autho…

Legal basis: Law on Medicinal Products plus Cabinet Resolution No. 345 of 18 July 2024

The Azerbaijani device registration regime rests on the Law of the Republic of Azerbaijan 'On Medicinal Products' (Articles 1.0.8, 6.1, 6.8, 6.14, 6 2, 9 1) and on Cabinet of Ministers Reso…

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

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'…

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

Sinif 1 — low risk degree (aşağı), Sinif 2a — medium risk degree (orta), Sinif 2b — high risk degree (yüksək), Sinif 3 — higher risk degree (daha yüksək)

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

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 Mi…

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

statement: Azerbaijan operates no recognition, abridged or fast track route for medical devices. The foreign (international) registration recognition mechanism in the Cabinet's registration…

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

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…

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

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, a…

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

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…

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

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 ann…

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

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…

Azerbaijani-language labelling content and notarised IFU translation

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 instr…

Manufacturer QMS certificate and declaration of conformity required in the dossier

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 con…

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

Import CoC / PVoC

Legal metrology type approval and verification

Metrology

Radio-frequency allocation permit and radio-equipment conformity certificate

Wireless / radio

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

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…

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

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 certificat…

Sinif 2a (medium risk) — state registration · National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry

7 working days

Sinif 2b (high risk) — state registration · National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry

7 working days

Sinif 3 (highest risk) — state registration · National state registration: application to the Ministry of Health, expertise by the Analytical Expertise Center, registration certificate issued by the Ministry

7 working days

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

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 certificat…

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

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…

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

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 r…

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

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…

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

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…

No source-verified answer is published for this dimension yet.

Grounds on which the Ministry suspends a device registration

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…

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

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 w…

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

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…

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

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 withi…