The Medicines and Medical Devices Agency of Serbia (ALIMS) is the country’s regulatory authority for medical devices, responsible for market access, compliance approval and post-market supervision of medical devices.
Link to the Agency’s official website:https://www.alims.gov.rs/english/medical-devices/
Database link: https://www.alims.gov.rs/english/
‘The Official Gazette of the Republic of Serbia’, Nos. 30/2010, 107/2012, 105/2017 and 113/2017
‘The Official Gazette of the Republic of Serbia’, No. 105/2017
EU Medical Devices Regulation (MDR)
Medical Device:
In vitro diagnostic reagents classification:
LIST A
① Reagents and reagent products used to determine blood groups in the ABO system, Rhesus Factor (C, c, D, E, e), “anti-Kell” and other blood groups, including control and calibration materials.
② Reagents and reagent products for the detection, confirmation and quantification of markers of HIV infection (HIV-1 and HIV-2), HTLV-I and HTLV-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 the determination of 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-erythrocyte antibodies, as well as control and calibration materials.
③ Reagents and reagent products for the detection and quantification of viral infections (such as rubella and toxoplasmosis) in human specimens, as well as control and calibration materials.
④ Reagents and reagent products for the diagnosis of hereditary diseases (e.g. phenylketonuria), as well as control and calibration materials.
⑤ Reagents and reagent products for the detection of human infections (e.g. 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 tumour markers (e.g. PSA), as well as control and calibration materials.
⑧ Reagents and reagent products for determining the genetic risk of trisomy 21, as well as control and calibration materials, including associated software.
⑨ Products for self-testing (e.g. products for measuring blood glucose levels), as well as control and calibration materials.
⑩ Self-testing devices: in vitro diagnostic medical devices intended for self-testing by non-professionals in a home setting.
Other in vitro diagnostic medical devices: other in vitro diagnostic medical devices not classified under LIST A or LIST B.
An authorised representative is a legal entity or natural person domiciled in the Republic of Serbia who has been solely authorised in writing by a foreign manufacturer to carry out, on its behalf, all procedures required by law in Serbia.
Both MD and IVD require ISO 13485 certification.
Manufacturers based outside Serbia must appoint an Authorised Representative located in Serbia. The Authorised Representative is responsible for liaising with ALIMS and ensuring that the products comply with local regulations. A product registration certificate or any other documentation certifying the safety and efficacy of the device must be issued by the regulatory authority of the country of origin or by a recognised Notified Body.
Registration Requirements: The registration procedures for medical devices with and without the CE mark in Serbia differ.
① Medical devices bearing the CE mark are those controlled by bodies recognised by the European Union, indicating that these devices comply with the EU Medical Devices Directive. Registration shall be carried out through an administrative procedure based on relevant certificates and documentation demonstrating compliance with the EU Medical Devices Directive.
② The registration of medical devices without the CE mark shall be based on an assessment of quality, safety and performance testing conducted in Serbia in accordance with internationally recognised standards.
Registration application form (Form 1);
EC Certificate or Declaration of Conformity;
Written authorisation and certified translation;
ISO 13485 certificate or other quality system certification;
Summary of technical documentation (design, performance, clinical evaluation, etc.);
Instructions for use (IFU) and labelling in Serbian. ALIMS will further promote fully electronic submission via the ePortal from 2025 onwards.
If the conformity assessment procedure requires the involvement of a conformity assessment body, one of the following bodies must be selected to carry out the conformity assessment within the relevant scope:
1. A certification body (i.e. an accreditation body) whose head office is located in a Member State of the European Economic Area or in a country that has concluded a mutual recognition agreement on conformity assessment procedures with the European Commission;
2. Or a designated or authorised body with an office in the Republic of Serbia.
Instructions and labels must be in Serbian; other registration documents may be in English.
The registration process takes 1–2 months:
ALIMS will register medical devices that meet the basic requirements within 30 days of the applicant submitting the request.
If the medical device registration application is incomplete, ALIMS will notify the applicant within 15 days of receiving the application and require the applicant to submit supplementary documents within 30 days of receiving the notification.
Official Fees
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.
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.