Medical Device Registration and Approval in Serbia
General country-specific regulatory information is provided on this page for medical device registration and approval in Serbia.
Last updated on November 17th, 2021.
Medical Device Regulations and Classification in Serbia
REGULATORY AUTHORITY: Medicines and Medical Devices Agency of Serbia (ALIMS)
Medical Devices: I/IIa/IIb/III
IVDs: List A/List B/Self-testing/Others
TIMEFRAME: The official timeline for the registration process is 82 working days (excluding time needed for the conformity assessment procedure).
SPECIAL REQUIREMENTS: Non-CE marked devices might need to be tested in the local laboratory.
LOCAL FEES (New Application):
Class I: USD 118 (up to 25 products); USD 95 (26-100 products); USD 71 (more than 100 products).
Class IIa: USD 294 (up to 25 products); USD 236 (26-100 products); USD 177 (more than 100 products).
Class IIb: USD 353 (up to 25 products); USD 283 (more than 25 products).
Class III: USD 589 (up to 15 products); USD 471 (more than 15 products).
AIMD: USD 589 (up to 10 products); USD 471 (11-25 products); USD 353 (more than 25 products).
In-vitro Diagnostics (IVDs)
List A and B: USD 141 (up to 25 products); USD 118 (26-100 products); USD 103 (more than 100 products).
Self-Testing: USD 118 (up to 25 products); USD 94 (more than 25 products).
Other: USD 118 (up to 25 products); USD 103 (26-100 products); USD 95 (101-200 products); USD 72 (more than 200 products).
LOCAL FEES (Manufacturer): No manufacturer registration is required.
LICENSE VALIDITY: The validity of the registration certificate will follow the validity of the certificate of conformity (plus 60 days after the expiry date), except for Class I medical devices (non-sterile, non-measuring) and other IVDs, the registration certificate will be valid for 5 years.
LICENSE TRANSFER: License transfer or changes to the AR of the manufacturer is possible and considered as an amendment.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: Foreign manufacturer without any representative office or branches that residing in the Republic of Serbia must appoint a legal or natural person with a head office in the Republic of Serbia to become their authorized representative.
Changes following the implementation of the EU MDR must be anticipated:
- Class I medical devices (sterile, have a measuring function or are reusable surgical instruments) whose conformity certificates were issued before May 26, 2021.
- Certificates issued in accordance with the requirements of Directives 93/42/EEC and 90/385/ EEC shall remain valid until the date specified on the certificate but no later than May 26, 2024.
Other Europe (non-EU) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Switzerland, Turkey, Ukraine
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