Chapter 1 Serbian ALIMS Administration Information Abstract

1. Administration and Abstract

The Medicines and Medical Devices Agency of Serbia (ALIMS) is the country's administration for medical devices, responsible for market access, compliance approval, post-marketing supervision and management of medical devices.

2. Administrative Regulation

"The Official Gazette of the Republic of serbia”, No. 30/2010 107/2012105/17 and 113/2017

"The Official Gazette of the Republic of Serbia" , No. 105/2017

EU Medical Devices Regulation (MDR)

3. Risk Level Classification of Medical Device and IVD Products

Medical Device:

In vitro diagnostic reagents classification:

LIST A

①Reagents and reagent products for determining blood groups such as ABO blood group system, Rhesus Factor (C, c, D, E, e) "anti-Kell", including control and calibration materials.

②Reagents and reagent products for the detection, confirmation and quantification of markers of HIV infection (HIV 1 and 2), HTLV I and II, hepatitis B, hepatitis C and hepatitis D in human specimens, as well as control and calibration materials.

LIST B

① Reagents and reagent products for determining blood groups such as "anti - Duffy" and "anti - Kidd", as well as control and calibration materials.

② Reagents and reagent products for the detection of unacceptable anti-red blood cell antibodies, as well as control and calibration materials.

③Reagents and reagent products, as well as control and calibration materials, for the detection and quantification of similar infections (e.g. rubella, toxoplasmosis, etc.) in human specimens.

④Reagents and reagent products for the diagnosis of genetic disorders (e.g., phenylketonuria), as well as control and calibration materials.

⑤Reagents and reagent products for the detection of human infections such as cytomegalovirus and chlamydia, as well as control and calibration materials.

⑥ Reagents and reagent products for determining HLA tissue groups (DR, A, B), as well as control and calibration materials.

⑦ Reagents and reagent products for the determination of tumor markers such as PSA, as well as control and calibration materials.

⑧ Reagents and reagent products for determining trisomy 21 genetic risk specificity, as well as control and calibration materials, including related software.

⑨ Products for self-diagnosis (such as those that measure blood sugar levels), as well as control and calibration materials.

⑩ Equipment self-testing: in vitro diagnostic medical devices for non-professionals to conduct self-testing in a home environment.

Other in vitro diagnostic medical devices: Other in vitro diagnostic medical devices not classified in LIST A and LIST B.

4. Entry Requirements

Both MD and IVD require ISO 13485.

For manufacturers outside Serbia, an Authorized Representative located in Serbia is required. Authorized representatives are responsible for communicating with ALIMS and ensuring that products comply with local regulations. A certificate of product registration issued by a regulatory authority or recognized notified body in the country of origin or any proof of the safety and effectiveness of the device.

Registration requirements: The registration procedure for medical device registration in Serbia is different for medical devices with and without the CE mark.

①A medical device with the CE mark refers to a device controlled by an institution recognized by the European Union, which means that these medical devices comply with the European Union directive on medical devices. Registration shall be carried out through an administrative procedure on the basis of the relevant certificates and documents in compliance with the EU Medical Device Directive.

②Registration of medical devices without the CE mark shall be carried out on the basis of an assessment of quality, safety and efficiency tests carried out in Serbia in accordance with internationally recognized standards.

5. Registration Language

Instructions and labels are in Serbian, other registration materials can be in English.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

The registration cycle is 1-2 months:

ALIMS will register medical devices that meet the basic requirements within 30 days from the date of submission of the request.

If the application for registration of a medical device is incomplete, ALIMS will notify the applicant within 15 days from the date of receipt of the application and request the applicant to supplement the application documents within 30 days from the date of receipt of the notification.

Official Fee

Chapter 3 FAQ

Q: What is the regulatory policy for medical devices and IVDs in Serbia?

A: Regulatory regulations: Serbia has adopted the European Medical Device Directive and regulates medical devices according to relevant regulations. Its regulatory requirements cover registration, production, import, sales, use and other links.

Special requirements: Non-CE marking devices may need to be tested at a local laboratory.

Q: How long is the validity period of the medical device registration certificate?

A: In Serbia, medical device registration certificates are generally valid for 5 years. However, it should be noted that the registration certificate of Class I medical devices (non-sterile, non-measuring) and other in vitro diagnostic reagents (IVD) is valid for 5 years; For non-CE marked Class I medical devices (sterile, measuring), the registration certificate is valid for 3 years.