Medical devices

Within the system of health-care service provision, and for the purposes of disease prevention, diagnosis, treatment, and rehabilitation of the Serbian population, 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.

Legally regulated marketing of medical devices in Serbia has been carried out since 1993, when the field of production and marketing of medical devices was regulated for the first time in our country by the Law on Production and Trade of Medicines. Based on the Law on Medicinal Products and Medical Devices, adopted in 2010, medical devices were registered in the Register, as a requirement for their marketing in our country.

The new Law on Medical Devices was adopted in 2017, and its full implementation began at the end of 2018. In accordance with the applicable Law and by-laws adopted for its implementation (regulations), ALIMS’ activities in the field of medical devices are carried out in electronic form, in accordance with the law governing electronic operations. The application for registration of a medical device is submitted by the manufacturer, or by the authorized representative of the manufacturer of medical devices.

ALIMS maintains the “Register of Medical Devices”, including all relevant data related to medical devices registered in the Republic of Serbia. Also, ALIMS registers in the “Register of Manufacturers” all foreign manufacturers (including their representative offices and Регистрација медицинских средстава
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 the Serbian population, 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.

Legally regulated marketing of medical devices in Serbia has been carried out since 1993, when the field of production and marketing of medical devices was regulated for the first time in our country by the Law on Production and Trade of Medicines. Based on the Law on Medicinal Products and Medical Devices, adopted in 2010, medical devices were registered in the Register, as a requirement for their marketing in our country.

The new Law on Medical Devices was adopted in 2017, and its full implementation began at the end of 2018. In accordance with the applicable Law and by-laws adopted for its implementation (regulations), ALIMS’ activities in the field of medical devices are carried out in electronic form, in accordance with the law governing electronic operations. The application for registration of a medical device is submitted by the manufacturer, or by the authorized representative of the manufacturer of medical devices.

ALIMS maintains the “Register of Medical Devices”, including all relevant data related to medical devices registered in the Republic of Serbia. Also, ALIMS registers in the “Register of Manufacturers” all foreign manufacturers (including their representative offices and branches), whose medical devices are registered in the Republic of Serbia, as well as all domestic manufacturers of medical devices. Registration of a medical device is submitted on Form 1 with the appropriate documentation and proof of payment. The application may refer to the registration of multiple medical devices having the same category and risk class, manufactured by the same manufacturer, which are covered by the same certificates of conformity. The trade of registered medical devices is carried out based on a valid decision on registration.

ALIMS issues a decision on registration of a medical device, valid 60 days after the expiry of the validity term of the certificate of conformity. Medical devices can be marketed for a maximum of 90 days from the date of expiry of the decision on registration of a medical device.

In accordance with the Law, ALIMS may authorize the trade of unregistered medical devices, only at the request of import proponent (health care institution, private practice, social welfare institution, humanitarian organization, patient association and the ministry responsible for defense affairs and the ministry responsible for emergency situations).

ALIMS also issues approvals for clinical trials of medical devices and monitors their safety, i.e. vigilance, as well as the surveillance of medical devices in the market.

ALIMS regularly publishes on its official website the “Register of Medical Devices”, the “Register of Manufacturers” and the “Register of Authorized Representatives of Manufacturers of Medical Devices”.