Serbia - MedStandard

Serbia

Medicines and Medical Devices Agency of Serbia (ALIMS)

Law on Medicines and Medical Devices of Serbia

82 working days

(excluding time required for the conformity assessment procedure)

country resident

5 years

Serbian

Non-CE marked devices might need to be tested in the local laboratory.

A brief algorithm for registration of medical devices in Serbia:

01

Determination of the device classification

02

Appointment of an Authorized Representative

03

Preparation of application form and registration dossier

04

Submission of a product samples for testing

05

Submission will be reviewed by the Competent Authority

06

Once approves, the registration certificate will be issued

Final price and terms procedures will be calculated according to your request