• Mob: +994777276006  Mob: +994777276006
  • office@makromed.az [email protected]
Makromed Logo
  • Home
  • About
    • About
    • Company Legal Structure
    • Gallery
    • Contact
  • Services
    • Pharmacovigilance
    • Registration of Medicinal Products
    • Registration of Food supplements (FS)
    • Other services
    • Projection and design
  • Products
    • Medicine
    • Food supplements
    • Hygiene product
    • Medical device
    • Cosmetic product
  • Pharmacovigilance
    • Online notifications
  • Training
  • Information
    • Blog
    • News
    • Legislation

INFORMATION related to state registration of medical devices

  1. Home
  2. News
  3. INFORMATION related to state registration of medical devices

Categories

  • Medicine
  • Drug
  • Interesting
  • World
  • Azerbaijan
Makromed

If you haven't found the answers to your questions in our Frequently Asked Questions section, don't worry - we're here to help!

Contact Us
INFORMATION related to state registration of medical devices

INFORMATION related to state registration of medical devices

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 Medicinal Products", except for medical products belonging to risk group I, medical products 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, Medicines 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, the acceptance of documents to the public legal entity "Analytical Expertise Center" for the import of medical devices (except for medical devices included in the I risk class) and examination of whether they are medical devices or not is temporarily suspended from 22.07.2024.

From the date of entry into force (approval) of this rule, the dates of invoices and bank payments submitted by companies should not exceed the date of approval of that rule.
Example: If the rule was approved on 19.07.2024, then applications for invoices or bank payments by 19.07.2024 will be accepted.

Please check the official website www.pharma.az regularly for updates. You can see the effective documents from the links posted on the website.

https://e-ganun.az/framework/56982 Classification of medical devices depending on the degree of risk

https://e-qanun.az/framework/56983 On approval of the list of medical devices with a higher, high and (or) medium risk level

https://nk.gov.az/az/senedler/qerarlar/derman-vasitelerinin-derman-maddelerinin-ve-tibb-v-8191

Note: until 22.07.2024, an expert opinion on whether it is a medical device has been applied for, unpaid applications will be terminated.

Makromed Logo White

MAKROMED LLC is one of the best and leading qualified consulting companies in Azerbaijan established in 2013. Now it’s a part ...

Usefull links

  • Blog
  • News
  • Legislation
  • Gallery

Training

  • Active trainings
  • Deaktive trainings
  • Structure
  • Pharmacovigilance

Services

  • Pharmacovigilance
  • Registration of Medicinal Products
  • Registration of Food supplements (FS)
  • Other services
  • Projection and design

Contact

Mob: +994777276006

Mob: +994777276006 Tel/Fax: +994124098090

office@makromed.az

[email protected]

Binagadi  district ,Svetlana Mammadova 203C Baku , Azerbaijan AZ1114

Binagadi district ,Svetlana Mammadova 203C Baku , Azerbaijan AZ1114

©2025 Makromed.az All rights reserved

  • About
  • Pharmacovigilance
  • Products
  • Contact