Registration in the Register of Medical Devices
Within the system of health-care service provision, and for the purposes of disease prevention, diagnosis, treatment and rehabilitation of affected population in Serbia, it is necessary to provide the widest range of quality, safe and efficient medical devices and thus prevent marketing of low-grade and unregistered products.
The marketing of medical devices in Serbia, stipulated by Law, is conducted since 1993 when the field of production and marketing of medical devices was regulated for the first time in our country on grounds of the Law on Production and Marketing of Medicines. Since then and to this day, nearly 30,000 medical devices have been marketed in Serbia.
Today, on grounds of the Law on Medicines and Medical Devices, adopted in 2010, registration in the Register of Medical Devices is performed as a condition for marketing medical devices in our country. Registration, renewal of registration, as well as amendments to the registration of medical devices in the Register of Medical Devices are all conducted in the Medicines and Medical Devices Agency of Serbia (ALIMS). ALIMS cooperates in these activities with the manufacturers of medical devices, their representative offices, agents and distributors, as well as with the Committee for Medical Devices and appointed experts – colleagues of ALIMS.
The registration procedure in the Register of Medical Devices is different for medical devices with and without the CE-mark.
Medical devices with the CE-mark refer to the devices controlled in an institution accredited by the European Union and means that these medical devices are compliant with the EU directives on medical devices. Registration in the Register shall be performed by an administrative procedure based on relevant certificates and documents on compliance with the EU directives on medical devices.
Registration of medical devices without the CE-mark shall be performed based on the evaluation of performed quality, safety and efficiency tests which are conducted in our country, in accordance with internationally accepted standards.
Issuance procedure for the Decision on registration of medical devices in the Register of Medical Devices is in accordance with the Guidelines of Good Regulatory Practice.
Documentation, in terms of data exclusivity, is especially kept in the manner prescribed by the EU. Since Serbia is not yet an EU member state, national authorization is issued – the Decision on registration of medical devices in the Register of Medical Devices for the marketing of medical devices, but relevant foreign certificates and documents are also recognized which prove the compliance with EU directives on medical devices and guarantee the quality, safety and efficiency of medical devices.
In accordance with the Law, ALIMS may authorize marketing of unregistered medical devices only at the request of certain health-care facilities for the treatment of life-threatened patients or groups of patients, as well as for some scientific or medical research. ALIMS also issues authorizations for clinical trials of medical devices and monitors their safety and vigilance.
ALIMS published database of medical devices and lists of medical devices, which are entered in the Register of Medical Devices on the ALIMS website.