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 lead time for the medical devices registration in Azerbaijan is up to 3 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 or tests
The Regulator usually gets samples of each item in the Application, and does internal testing within a week on average. No extra expenses for laboratory tests apply on customers so far.
Step 3. Getting a 5-year Registration certificate
Documents and samples get checked for about 1 month total. We pick up your Registration Certificate and can send it to yours.For detailed expenses and process lead time please contact us:
Frequently Asked Questions about the medical devices registration in Azerbaijan
Q.: Do I need a local Authorized Representative (AR) to complete the registration?
A.: A sole locally-established AR is not required currently, yet plans to introduce them to fulfil reporting functions exist. We will notify our customers on the terms and conditions once such a law comes into force.
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, Japan, Korea-registered devices?
A.: So far, no. Only regular registration process applies.
Q.: How many samples required for the tests?
A.: The legislation requires 3 samples of each items stated in Registration dossier.
Q.: How long does it take to apply updates to the existing Registration?
A.: It could take 1-2 months total. The Registration certificate` expiration date doesn`t get renewed eventually.
Q.: What are State fees for the registration like?
A.: As of October 2024, 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