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Serbia medical device government fees

Row-level verified

ALIMS current fee schedule, reviewed for 2026, in RSD.

13 fee lines100% exact amountscurrency RSDFX rates 2026-09-28reviewed 2026-08-25
Fee lineOfficial amountUSD equivalentFrequencyProvenance
Registration - Class I, up to 25 productsRSD 13,450$130Per deviceVerified
Registration - Class I, 26–100 productsRSD 10,800$105Per deviceVerified
Registration - Class I, over 100 productsRSD 8,100$78.55Per deviceVerified
Registration - Class IIa, up to 25 productsRSD 33,600$326Per deviceVerified
Registration - Class IIa, 26–100 productsRSD 26,900$261Per deviceVerified
Registration - Class IIa, over 100 productsRSD 20,200$196Per deviceVerified
Registration - Class IIb, up to 25 productsRSD 40,400$392Per deviceVerified
Registration - Class IIb, over 25 productsRSD 32,300$313Per deviceVerified
Registration - Class III, up to 15 productsRSD 67,300$653Per deviceVerified
Registration - Class III, over 15 productsRSD 53,800$522Per deviceVerified
Annual vigilance fee per registered device
RSD 1,180 Class I and IVD class A; 1,770 IVD List A/B and self-testing; 2,360 Class IIa; 3,540 Class IIb; 5,900 Class III and active implantables.
RSD 1,180–5,900$11.44–$57.22Annual, by 30 AprilVerified
Free Sale CertificateRSD 14,200$138Per certificateVerified
Commercial clinical-trial approval
Ethics Committee of Serbia charges RSD 200,000 for the first site and RSD 150,000 for each further site; non-commercial trials RSD 25,000 (further sites 18,000).
RSD 371,700$3,605Per approvalVerified
Government fees only β€” service and testing costs are separate
  • Article 12 of the current ALIMS decision (Sl. glasnik RS 98/2023, applied from 1 January 2024) sets the amount for each individual device according to class and the number of products in the request.
  • Registration renewal is 50% of the applicable registration tariff; amendments requiring a new decision cost RSD 11,800 (RSD 1,180 without a decision); conformity assessment is RSD 283,200; import approval for an unregistered device is RSD 17,700.
  • IVD and active-implantable registration rows are also published in the linked decision.
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Exact amounts verified against the ALIMS fee schedule Β· full review 2026-08-25 Β· row IDs are stable β€” cite as government-fees:serbia:registration-class-i-up-to-25