| Regulatory Authority | Medicines and Medical Devices Agency of Serbia (ALIMS) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | Medical Device Laws | Click Here |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines | Medical device classification rules is based on Annex VIII; Chapter III of EUMDR 2017/745 |
| Registration Process | Registration in the Register of Medical Devices | Click Here |
| Registration Timeline | 3 months |
| Technical Documentation Format |
The applicant must prepare technical documentation for the device. This includes its design, intended use, performance characteristics, clinical evaluations, labeling, and instructions for use. This step is vital to demonstrate the device’s compliance with safety standards. |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Serbian or English Language |
| Labeling Requirements |
The label should include the manufacturer’s name and address, the device’s intended use, and storage or handling instructions. The instructions for use must also be in Serbian. |
| Clinical Trials Information |
Clinical trials of medical devices are carried out based on the following: |
| Database | Search for medical devices | Click Here |
| Declaration of Conformity |
Article 224: Marketing authorisation with a Certificate of conformity issued in accordance with regulations that are valid until this Law comes into operation are valid for 90 days from the expiration date on the Certificate of conformity on the grounds of which the marketing authorisation was issued. | Click Here |
| Post Market Surveillance |
Medical Devices Vigilance | Click Here |
| Adverse Event Reporting Timelines | Marketing authorisation holder is obliged to keep records of all suspected serious adverse reactions to medicinal product that have been reported by health or veterinary professionals, or of which he can reasonably be expected to be aware, an |
| Advertising and Promotions |
Advertising of medical devices includes: 1) advertising of medical devices through the public media, including the Internet, advertising in public places and other forms of advertising medical devices (by mail, visits, etc.); 2) promotion of medical devices to healthcare professionals who prescribe medical devices and/or who use medical devices, by informing them at professional meetings, in professional magazines and other forms of promotion; 3) providing free samples to the professional public; 4) sponsoring scientific and promotional gatherings attended by the professional public | Click Here |
| Additional Information | Marketing authorisation is valid for five years, starting from the date the decision to grant the marketing authorisation is made |
| Contact Phone | Fax +381 11 3951 131, +381 11 3951 147 |
| Contact Email | hygia@alims.gov.rs |
| Contact Address | 458 Vojvode Stepe Street, Belgrade 11221, Serbia |