We inform you that according to the Law No. 979-VIQD dated July 14, 2023 of the Republic of Azerbaijan “On Amendments to the Law of the Republic of Azerbaijan “On Medicines”, except for medical devices belonging to risk group I, medical devices cannot be imported without state registration.
2007 of the Cabinet of Ministers of the Republic of Azerbaijan on approving the “Rules for State Registration of Medicines, medicinal substances and medical devices, Entering them in the State Register and Keeping the State Register” and “Rules for State Registration and Keeping the Register of Medicines” The decision dated 19.07.2024 on the cancellation of Decision No. 108 dated July 13 was approved.
In this regard, from July 22, 2024, the acceptance of documents to the public legal entity “Analytical Expertise Center” for import (with the exception of medical devices belonging to risk class I) and expertise of medical devices to determine whether the medical devices is a medicines is temporarily suspended.
From the date of entry into force of this rule (approval), the date of invoices and bank payments submitted by companies must not exceed the date of approval of this rule.
Example: If the rule was approved on 07/19/2024, this means that invoice applications or bank payments made before 07/19/2024 will be accepted.
Please check the official website www.pharma.az regularly for updates. To view documents that have entered into force, follow the links posted on the site.
Classification of medical devices depending on the degree of risk
https://e-qanun.az/framework/56982
On approval of the list of medical devices with a higher, high and (or) medium degree of risk
https://e-qanun.az/framework/56983
https://nk.gov.az/az/senedler/qerarlar/derman-vasitelerinin-derman-maddelerinin-ve-tibb-v-8191
Note: until July 22, 2024, unpaid applications for examination to determine whether a medical product is a medicinal product will be canceled.
