Regulatory Update: Serbia

On June 8, 2023, the Serbian Food and Drug Agency (ALIMS) introduced an Important Notice regarding reporting in the ALIMS information system for the Surveillance System for medical devices on the Market.

This notice outlines two types of reporting that are now required:

1) Post-Market Surveillance Report (PMSR): This reporting applies to Class I medical devices (except Is, Im, Ir) and Class A or other IVDs. Manufacturers are expected to update the post-marketing monitoring report (PMSR) as necessary and submit it to the Agency upon request.

2) Periodic Safety Update Report (PSUR): For medical devices falling under Is, Im, Ir, IIa, IIb, III, AIMD categories and IVDs in List A, List B, self-testing, class B, class C, and class D, periodic safety update reports (PSUR) must be maintained. The update frequency varies, with some categories requiring submissions at least once every two years while others are due annually.

In addition, there is a new deadline for reporting in the "Surveillance System for Medical Devices on the Market," which can be found here with the FULL resource. Cyrillic and English translations are available. 

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