MEDICAL DEVICE REGISTRATION AND APPROVAL IN Serbia

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 update: December 2022

Medical Device Regulations and Classification in Serbia

REGULATORY AUTHORITY: Medicines and Medical Devices Agency of Serbia (ALIMS)

CLASSIFICATION SYSTEM:

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):

Medical Devices

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.

ADDITIONAL INFORMATION:

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: BelarusBosnia & HerzegovinaIcelandLiechtensteinMacedoniaMoldovaNorwaySwitzerlandTurkeyUkraine

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