Overview of the Medicines and Medical Devices Agency of Serbia (ALIMS) and Medical Device Regulation

Medicines and Medical Devices Agency of Serbia (ALIMS) - Overview

The Medicines and Medical Devices Agency of Serbia (ALIMS) (Serbian: Agencija za lekove i medicinska sredstva Srbije) is the national competent authority under the aegis of the Ministry of Health of the Republic of Serbia. Founded on October 1, 2004, ALIMS regulates and monitors the development, manufacturing, and trade of both human and veterinary medicinal products and medical devices within the country.

Key Roles and Responsibilities

ALIMS ensures that medical technologies available in the Serbian healthcare market meet the highest standards of safety, quality, and efficacy through several key regulatory mechanisms:

• National Registration: Unlike EU member states with centralized database notifications, Serbia mandates a national registration process through ALIMS. This applies even to devices that already bear the CE mark. Approved items are compiled into the official "Register of Medical Devices".
• Authorized Representation: For foreign manufacturers, appointing a local authorized representative based in Serbia is mandatory. This representative serves as the primary regulatory liaison and manages registration submissions.
• Vigilance and Incident Reporting: Coordinates the national materiovigilance network via its electronic system (ePortal MS). ALIMS systematically tracks Manufacturer's Incident Reports (MIRs), Field Safety Corrective Actions (FSCAs), and coordinates with healthcare institutions through designated vigilance coordinators.
• Market Surveillance: Performs post-market controls in collaboration with the Ministry of Health to ensure products on the market remain safe, perform optimally, and feature compliant Serbian-language labeling and instructions for use.
• Clinical Investigations: Reviews, evaluates, and issues legal authorizations for conducting clinical trials and investigations for medical devices on Serbian territory.

Regulatory Framework

The regulatory environment under ALIMS is governed by:

• The Serbian Law on Medical Devices (2017), which replaced older frameworks to facilitate strict alignment with European standards.
• Progressive harmonization with the European Union's Medical Device Regulation (MDR) - Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) - Regulation (EU) 2017/746.