Alims ALiMS Vlada Republike Srbije
ALiMS
Granting of Marketing Authorisations for Medical Devices

In Serbia Marketing Authorisation granting for Medical Devices has started in 1995 in accordance with the Law on Manufacturing and Marketing of Medicines and Medical Devices that was in force from 1993 to 2004.

Manufacturing and marketing of medical devices in Serbia was for the first time regulated by this law. From that time till today about 4000 Marketing authorisations for medical devices were issued. Today, in accordance with the new Law on Medicines and Medical Devices the Marketing Authorisations for Medical Devices, as well as Marketing Authorisation renewals and variations are issued by the Medicines and Medical Devices Agency of Serbia.

In performing the task the Agency cooperates with the manufacturers of the medical devices, their representative offices, distributers as well as with the Committee for Marketing Authorising of Medical Devices and with indipendent experts advisers to the Agency.
The procedure for Marketing Authorising of a medical device depends on wether the device has a CE mark or not. For medical devices with a CE mark, i.e. sertified by an accredited EU institution, Marketing Authorisation is granted based on the assessment of the manufacturers documentation only (technical file and administrative data).

Medical Devices that do not posses the CE mark, Marketing Authorisations are granted based on results of quality, efficacy and safety evaluations performed in Serbia according to internationally recognized standards. The Marketing Authorisation procedures for medical devices are harmonised with the Good Regulatory Practice Guidelines.

Data exclusivity documentation is protected as prescribed by EU. According to the Law on Medicines and Medical Devices domestic manufacturers of medical devices without CE mark are given a 5 year transition period to ajust to the EU regulation requirements.