Azerbaijan Medical Device Registration: Who Can Be the Applicant

1. Key takeaways

This is one of the most distinctive design features of the Azerbaijani device system. Article 2.1.1 of the Resolution No. 345 Rules divides applicants into two categories: for medicinal products and drug substances the applicant can only be the inventor, the manufacturer, a wholesale pharmaceutical enterprise or the Ministry of Health, whereas the applicant for a medical device may be a legal entity or an individual entrepreneur that is neither a medicinal product manufacturer nor a wholesale pharmaceutical enterprise. In other words, a local trading company unrelated to pharmaceuticals, a consultancy, or even an individual entrepreneur can act as the applicant for state registration of a device.

Read together with Article 6.1 of the Law on Medicinal Products, the value of this provision becomes clearer: the medicinal product chain restricts applicants to industry insiders, while the device chain is fully open. For foreign manufacturers this means that they do not necessarily have to come forward themselves, nor do they have to look for a partner holding pharmaceutical qualifications.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024, approving the Rules on State Registration of Medicinal Products, Drug Substances and Medical Devices, Entry into the State Register and Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Collection 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024): Article 2.1.1 (definition of the applicant, including the device-specific wording), Article 4.2 (submission to the Ministry of Health by the applicant), Article 3.5 (documents evidencing authority must accompany submissions made by an authorized representative).
• Law of the Republic of Azerbaijan on Medicinal Products (Dərman vasitələri haqqında, No. 208-IIIQ, adopted December 22, 2006, effective February 28, 2007, Legislative Collection of the Republic of Azerbaijan, 2007, No. 2, item 70), as amended by Law No. 979-VIQD of July 14, 2023 (adding Articles 1-1 and 9-1 as new provisions, Legislative Collection 2023, No. 8, item 1127): Article 6.1 (general requirements of state registration and the scope of applicants), Article 1-1 (the list of provisions not applicable to devices).
• Law of the Republic of Azerbaijan on Licenses and Permits (Lisenziyalar və icazələr haqqında, No. 176-VQ of March 15, 2016), Articles 18.2.1 to 18.2.3, Article 19.9, Article 25 and Article 26.1: Articles 18.2.1 to 18.2.3 (extract from the state register of legal entities, identity card, taxpayer identification number).

3. Expert insights

Insight 1: opening the device applicant threshold is the most substantive relaxation of the 2024 rules compared with the medicinal product system. Article 2.1.1 uses an exclusionary definition, namely a legal entity or individual entrepreneur that is not a medicinal product manufacturer and not a wholesale pharmaceutical enterprise. The strength of this definition is its extremely wide coverage; the weakness is that it sets no competence threshold at all: entities without a quality system, without warehousing and without technical capability can also submit. For foreign manufacturers this is both a convenience, because the choice of channels is wide, and a risk, because the certificate holder may know nothing about compliance.

Insight 2: the applicant and the certificate holder are not the same person, and the two positions can be split. Article 2.1.1 defines the person who makes the application, while in the Annex 5 device certificate the field following this certificate is issued to names another party. In practice a local agent can submit as the applicant while another entity serves as the certificate holder. But there is only one certificate and only one holder, so the arrangement between the two must be fixed in the authorization letter; otherwise the recipients of future changes, renewals and suspension notices all become uncertain.

Insight 3: Article 3.5 leaves room for authorized submission, but the requirement is specific. If documents are submitted by a person (representative) authorized by the applicant, the application must be accompanied by documents evidencing the corresponding rights, such as a power of attorney or a contract. This is an independent document: a distribution contract cannot substitute for a power of attorney, because a distribution contract governs a purchase and sale relationship, while a power of attorney governs the authority to submit.

Insight 4: foreign legal entities can also act as applicants, but the document requirements differ. Article 3.2.2 for medicinal product applicants provides that resident legal entities submit an extract from the state register of legal entities, while foreign legal entities submit proof of registration in their country of residence. Although the device dossier does not directly apply Article 3.2, Article 4.2.10 requires the documents of Articles 18.2.1 to 18.2.3 of the Law on Licenses and Permits, where Article 18.2.1 covers legal entities and the branches and representative offices of foreign legal entities, Article 18.2.2 covers individual entrepreneurs, and Article 18.2.3 covers the taxpayer identification number. All three point to an identifiable registered presence in Azerbaijan.

4. Practical recommendations

1. When selecting the applicant, prefer an entity with a legal entity registration or a branch or representative office registration in Azerbaijan, to satisfy Articles 18.2.1 to 18.2.3 more easily.
2. State in the power of attorney all three items: the authority to submit, the certificate holder arrangement, and the recipient of future changes, renewals and suspension notices, to avoid granting submission authority without follow-up arrangements.
3. Issue the power of attorney as a standalone document and do not mix it with the distribution contract; if notarization or legalization is required locally, prepare the Azerbaijani translation together with it.
4. Run a compliance capability assessment of the partner (Azerbaijani language capability, ability to receive registered mail, ability to respond to a 10 working day deficiency notice) rather than looking only at its business license.
5. A change of applicant is a change of registration information and must be handled as a new state registration project under Article 1.5.
6. Keep scanned copies of the applicant qualification documents (register extract, identity card, taxpayer number) and their Azerbaijani translations, for reuse in the dossier and in later changes.

5. Verification checklist

• □ The type of applicant entity has been confirmed (legal entity, branch or representative office of a foreign legal entity, or individual entrepreneur).
• □ The three sets of entity qualification documents under Articles 18.2.1 to 18.2.3 have been prepared.
• □ A standalone power of attorney has been issued, covering submission authority and the certificate holder arrangement.
• □ The authorization letter designates the recipient and contact details for future changes, renewals and suspension notices.
• □ The Azerbaijani language capability of the partner and its ability to respond to a 10 working day deficiency notice have been assessed.
• □ Changes of applicant have been incorporated into the change management procedure (as a state registration under Article 1.5).

Related reading

• Article 08. The Local Footing of the Certificate Holder: Legal Entity, Branch or Individual Entrepreneur: https://www.grzanglobal.com/azerbaijan-medical-device-registration/certificate-holder-local-presence/
• Article 01. Who Regulates Medical Devices in Azerbaijan: the Ministry of Health Issues Certificates and AEC Performs Expertise: https://www.grzanglobal.com/azerbaijan-medical-device-registration/who-regulates-medical-devices-in-azerbaijan/
• Article 21. The Application Form (Annex 1): Completion Points and the Criminal Liability Declaration: https://www.grzanglobal.com/azerbaijan-medical-device-registration/application-form-annex-1/

This article was translated and published by GRZAN, the international regulatory affairs service of GRZAN Global. For professional support with medical device registration in Azerbaijan, regulatory strategy, dossier preparation and local representation, contact us at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.