Medical device registration in Azerbaijan
We help manufacturers and distributors bring medical devices to the Azerbaijani market: we determine the risk class from the declaration of conformity, assemble the registration dossier and file with the competent authority. If a device can be imported without registration, we arrange the import permit.
What's included
- Device classification and choice of procedure: registration or import without registration
- Review of manufacturer documents: CE/FDA, ISO 13485, declaration of conformity
- Preparation of the dossier, instructions and labels in Azerbaijani
- Appointment of an authorised representative in Azerbaijan
- Filing, responding to authority queries, obtaining the registration certificate
- Support with the first import and customs clearance
How it works
Classification
We determine the risk class and procedure.
2–3 daysDossier
We collect and translate documents and prepare the application.
2–4 weeksFiling and review
We file with the authority and respond to queries.
as per the authority's rulesCertificate and import
We obtain the registration certificate and support the import.
1–2 weeksDocuments required
- Declaration of conformity and manufacturer certificates (CE, ISO 13485)
- Technical description, instructions for use, labels
- Power of attorney from the manufacturer to the authorised representative
- Manufacturer's corporate documents
Checklist: documents for a residence permit and an LLC in Azerbaijan
A 2-page PDF: what to prepare before you travel, where an apostille is needed and where notarisation is enough, and the order of filing.
- Document list for LLC registration and for each residence permit ground
- Table: apostille vs notarisation — by country
- Document list and timelines for every step
- Common mistakes that get a file returned
Frequently asked questions
Is registration needed if the device has CE marking?
CE simplifies the review but does not replace national registration for most classes. For some categories import without registration is possible — we check for your device.
Who can be the applicant?
The manufacturer through an authorised representative in Azerbaijan, or a distributor holding a power of attorney from the manufacturer. We can act as the authorised representative.
What about consumables and software?
Medical software and consumables are also classified as medical devices; the procedure depends on the risk class.
Verified 5 Nov 2026. Sources: taxes.gov.az, migration.gov.az, e-qanun.az.
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