Azerbaijan Medical Device Registration

• Healthcare Transformation in Azerbaijan: Mandatory Insurance and Regulatory Dynamics

Overview

The Azerbaijan healthcare system underwent significant structural changes with the full implementation of mandatory health insurance in 2021. Administered by the Azerbaijani Management Union of Medical Territorial Units (TABIB), a public legal entity under the State Agency for Compulsory Health Insurance, the insurance scheme covers primary, inpatient, emergency, and specialized outpatient care. 

It also includes services such as laboratory services, physiotherapy, and invasive radiology, providing comprehensive medical coverage to citizens through various healthcare providers. The Ministry of Health plays a regulatory role in the healthcare system, overseeing public education, research, the development of medical equipment, and disease prevention. 

The government’s focus on implementing a health insurance program has directed investment toward ensuring widespread access to basic healthcare services, with less emphasis on modernizing and subsidizing equipment for public hospitals. Private hospitals have become prevalent, catering to those who can afford to pay. As of 2020, Azerbaijan had a total of 1,174 hospitals, with 656 of them being private. Notably, there is a notable U.S. business presence, particularly in the supply of hospital and laboratory equipment.

The importation of medical equipment and pharmaceuticals into Azerbaijan is a relatively straightforward process. The Law of the Republic of Azerbaijan on Medicinal Products governs the registration and permitting requirements for pharmaceutical products, medical devices, and related items. To import medical products into Azerbaijan, the product must be registered with the relevant executive authority.

Regulatory Authority

CSEEA Analytical Expertise Centre

The Analytical Expertise Center (AEC) was established in 2007 by the Ministry of Health of Azerbaijan Republic to strengthen state control over the quality, efficiency, and safety of medicines.

As a regulatory authority, AEC works with the World Health Organization (WHO), the Global Fund, and other international and private organizations. Its activities have expanded significantly in recent years, and it is an observer member of the European and US Farmakopeya.

AEC also serves as the teaching and training center for Azerbaijan Medical University’s Faculty of Pharmacy, offering specialized courses and training for students and post-graduate students.

Link for Ministry of Health

http://www.pharma.az/

Local Regulation

Law Of the Republic of Azerbaijan, “On Medicinal Products”

Classification

No Classification

Listing or Registration Requirements

• State registration of medical devices is not carried out in Azerbaijan.
• For the import of medical devices and medical equipment, it is necessary to obtain a confirmation letter regarding the classification of such products.
• Obtain a hygiene certificate from the Republican Center for Hygiene and Epidemiology of the Republic of Azerbaijan.
• Start Marketing your device in Azerbaijan.
• Resident or non-resident can be Authorised Rep

Documents Required for Registration

Registration Timeline

1-1.5 months

Registration Fee

License Validity

5 Years

How to import Medical Equipment?

A letter of authorization and a hygienic certificate are required.

Special Labelling Requirements

• Documents must be submitted in either in Russian, English, or in Azerbaijani
• Labelling in Turkish is allowed
• The instructions (user manual) should be submitted in Azerbaijani.

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

Pharmacovigilance

The Applicant is not obligated to establish and uphold a pharmacovigilance system. However, the Applicant must provide details on adverse events that meet specific criteria, encompassing all adverse events within the initial 5 years following registration, and all serious adverse events, to the competent authority. Reporting of information regarding serious and unexpected adverse events of the medicinal product should be expeditiously submitted to the competent authority, with a deadline not exceeding 3 days.

How OMC Medical can assist you with the process?

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk