Solutions
for medical devices registration in Azerbaijan.
With RedMed.
Our office in Baku is ready to obtain a 5-year Certificate for medical devices sales in Azerbaijan ,
as well to provide consultancy in regulatory affairs and marketing.
THE OVERVIEW
The Government of Azerbaijan has launched a medical device registration procedure in 2024.
A 5-year certificate will replace the previous issuance of one-time import permits
for each batch.
RedMed has been experienced with the local regulatory affairs since 2022.
We offer a full set of solutions: registrations, updates, importation services.
Our team is ready to assist with the Azerbaijan`s market entry and regulation support.
THE EXEMPTION
The medical device`s batch classified as risk class 1 according to the national registry of Azerbaijan obtains a one-time per each batch import permit.
Each time you intend to import a batch you have to obtain such a permit - ask us for help, instructions and prices for the importation services.
LEAD TIME
The lead time for the medical devices registration in Azerbaijan is up to 2 months,
from getting your documents for selection, notarization and translation to Azerbaijan language, and processing at the Regulator. Medical devices registration in Azerbaijan, once obtained, is valid for 5 years.
What Steps to follow?
Step 1. Initial documents selection, notarization and translation
We`ll need the device`s technical file information, an ISO 13485, markings example, a few reports and quality declarations. Azerbaijani Instruction for use, documentation and coordination with the Regulator is on us.
Step 2. No inspections (yet!) or tests
The Regulator checks out documentation, and does internal tests for the medical devices containing pharmaceutical or medicinal elements. No extra expenses for laboratory tests apply on customers so far - the QMS ins[ection is scheduled from Q4 2025 only.
Step 3. Getting a 5-year Registration certificate
Documents, and samples if required, get checked and expertised for about 1 months total.We pick up your Registration Certificate and can send it to yours.
Step 4. Post-marketing activities
This step can be skipped - the Regulator doesn`t demand any post-marketing reports, filling electronic systems or adverse effect information gathering as of June 2025. Yet, such procedures are expected to be introduced later, our experts keep an eye on this matter.
The state registration for medical devices in the Azerbaijan Republic conducted by Analytic Expertise Center of the Republic`s Healthcare Ministry.
The regulator`s website is pharma.az
Our procedure adheres strictly to the Azerbaijani Cabinet of Ministers` Decision N345, dated 18.07.2024 "State registration rules on inclusion into the State register, maintenance of the State register of medicals, medicinal substances and medical devices".
For detailed expenses and process lead time please contact us:
Frequently Asked Questions about the medical devices registration in Azerbaijan
Q: Does Local Authorized Representative (AR) play any role?
A: Currently the AR’s role is mostly formal and doesn`t require regulatory activities.
The Government plans to expand these responsibilities to include reporting and surveillance:
The Azerbaijani Government is planning to introduce a mandatory QMS inspection starting from Q4 2025. This development typically leads to the requirement of the local AR communicating and responding to inquiries from the Regulator. Azerbaijani local AR helps manufacturers maintain compliance with evolving regulatory requirements, and we are good to be your Authorised Representative in Azerbaijan.
Q.: Could I sell used medical devices to Azerbaijan?
A.: Yes, you can once the documentation of the device is checked at the regulator, and additionally you`ve obtained a copy of the document issued by the manufacturer on the suitability of medical devices for use. All the documents must be notarized and then translated to Azerbaijani language, and the translation will be notarized in Azerbaijan as well.
Q.: Our devices are class 2b in a country of origin. Will they be of the same risk class in Azerbaijan?
A.: The classification of medical devices and devices for in-vitro diagnostics in Azerbaijan differs significantly from the classification in the European Union and the United States. On May 21, 2024, Decisions of the Ministry of Health No. 8 (National classification of medical devices depending on the degree of risk) and No. 9 (List of products with high and medium risk levels) were adopted.
The allocation of a medical device to a certain class and the decision on its registration must be carried out in accordance with the legislation of Azerbaijan.
Q.: What are VAT rates for devices like?
A.: Azerbaijan participates in different tax agreements, please follow legislation of the country of the medical device origin for Azerbaijani import VAT rates.
Q.: Is there any kind of express registration for FDA, EC or UK, Switzerland, Japan, Korea-registered devices?
A.: So far, no. Only regular registration process applies.
Q.: How many samples required for the registration?
A.: As of 2025, samples are required only for medical devices that contain a pharmaceutical or medicinal component. In such cases, 2 samples of each item listed in the dossier must be provided. For general medical devices without medicinal content, samples are not required.
Q.: How long does it take to apply updates to the existing Registration?
A.: It could take 2-3 months total. The Registration certificate` expiration date doesn`t get renewed eventually.
Q.: What are State fees for the registration like?
A.: As of June 2025, a flat fee of 150 AZN ($89) applies. The Government intends to distinguish fee rates in accordance with risk classes - we`re waiting for this Government decree to be signed.
The fee is paid by our locally-established entity to the Regulator`s account in Azerbaijani manats.
For more information in regards of registrations, updates to existing Registration Certificates, risk class 1 entry permissions, customs and current legal environment, please write us:
hello@red-med.ru
REDMED AZERBAIJAN: BAKU, FIKRET AMIROV, 1
+994 12 493-11-66
red-med.ru
