Regulatory solutions
for medical devices in Azerbaijan.
With RedMed.
Our Baku office provides comprehensive expertise to obtain a 5-year Certificate in Azerbaijan, along with guidance
in regulatory compliance and strategic market development
THE OVERVIEW
The Government of Azerbaijan has launched a medical device registration procedure in 2024.
A 5-year certificate now replaces 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 regulatory solutions: registrations, updates, importation services.
Our team is ready to assist with the Azerbaijan`s market entry and building strategic opportunities with locals.
THE EXEMPTION
A batch of medical devices classified as risk class 1 according to its national registration, obtains a one-time per each batch import permit.
Each time you intend to import a batch you have to obtain such 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 5 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, composition data, markings example, a few reports and quality declarations. Azerbaijani documentation and coordination with the Regulator are on us.
Step 2. No inspections (yet!) or Tests
After paying State fee for each modification you intend to register, the Regulator reviews our dossier and does internal tests for the medical devices containing pharmaceutical or medicinal elements. The QMS inspections terms for all of 2a, 2b and 3 classes reportedly to be introduced in near future, as of 2026 these Inspections are not required.
Step 3. Getting a 5-year Registration Certificate
We get the dossier submission result within 3 months since the submission. Once ready, the drafts being sent to the Ministry of Healthcare for final approval - expect not less than one month for this procedure.We pick up your Registration Certificate from the Ministry of Healthcare - since this date, you are able to import devices to Azerbaijan with no limitations.
Step 4. Post-Marketing Activities
Although the Regulator doesn`t demand any post-marketing reports or filling electronic importation systems at the moment, as your AR, we still need to address adverse effect information, apply changes and updates to the dossier, make recalls and answer all of inquiries.
Our dedicated expert keeps an eye on this matter.
No Active UDI System for Medical Devices
While Azerbaijan currently operates a national track and trace system exclusive to pharmaceuticals, manufacturers should anticipate future regulatory expansion. Globally and regionally, similar frameworks transition to cover medical devices shortly after successful implementation for pharma (we`ve seen that trend in Russia and Uzbekistan).
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: Yes, as only local tax resident can apply for the Registration. The Regulator doesn`t require to put the AR`s credentials on the markings and IFU though. The post-marketing activities currently being under legal development - we submit no annual reports, clinical monitoring plans etc at the moment. The Government plans to expand AR responsibilities to include reporting common in other countries.
We are good to be your Authorised Representative in Azerbaijan. This role can or cannot involve importation and bulk sales - we are ready to do it for you, or you are good to select own distributor and import with his help.
The Regulator does not restrict imports to Authorized Representatives only. Any local entity holding a valid Registration Certificate is permitted to import medical devices into 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. Then, translated to Azerbaijani language, and the translation will be notarized in Azerbaijan as well - we provide this service locally.
Q.: Our devices are class 2b in a country of origin. Will they be of the same risk class in Azerbaijan?
A.: As a part of our service, we will determine risk class for your devices in Azerbaijan. 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, where we can find devices` risk classes.
Q.: Is there any kind of express registration or recognition 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 2026, samples are required only for medical devices that contain a pharmaceutical or medicinal component (pre-filled syringes, specific bandages etc). In such cases, 3 samples of each item listed in the dossier must be provided - as well, a State tests fee applies. For general medical devices, IVD or IVD reagents, SaMD, AI-powered devices, tests are not required.
Q.: Has any UDI, track-and-trace system for medical devices been implemented in Azerbaijan?
A.: No UDI system applies locally for medical devices, unlike in Russia, Uzbekistan or, starting from late 2026, in Kazakhstan.
Q.: Do we need a specific registration path for AI-containing devices, IVD devices for Azerbaijan?
A.: The Regulator doesn`t outline any specific requirements for AI-powered medical devices, or for IVD or IVD reagents in Azerbaijan in 2026. The State fee remains the same, no samples or specific tests required, and the timings stay within standard 5 months 'all-in'.
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. The Update fee applies.
Q.: What are State fees for the registration like?
A.: As of 2026, a flat fee of 150 AZN ($90) applies. This fee is paid for every modification of the devices you intend to register - the Regulator issues its own Registration certificate for each model/modification. Say, you have 4 types of endoscopic washers belonging to 1 family of devices - still, there will be 4 different certificates issued, with 4 sizes of the State fee paid.
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 settled 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
