Explore the medical device requirements currently available for Serbia, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
Registration has a defined expiry/extension cycle; exact current term should be rechecked against implementing rules before publication.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Extension service exists; file before expiry.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Changes not affecting safety/performance may be reported; other changes receive an agency decision.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Statutory Three Party Transfer Agreement
No If Change Registered
Law mirrors a detailed EU-style three-party change contract and requires prompt filing by manufacturer or new AR.
Structured from the R183 official-source atlas. Confirm the exact article or page before treating this as fact-level legal advice.
