Registers of medicine devices in Serbia

The Minister of Health of the Republic of Serbia enacted on August 20th,2018 Rulebook on the Registers maintained by the Serbian Chamber of Commerce, published in the „Official Gazette of the Republic of Serbia“ No. 65/2018 dated August 24th 2018 which shall come into force on the 1st of September 2018 and shall apply on the day of the commencement of the implementation of the Medical Devices Act (“Official Gazette of RS” No. 105/17), i.e. on December 1st , 2018, except for Article 4. Paragraph 1, item 10 which shall apply after six months from the date of application of that law.

This Rulebook prescribes data that are entered in:

• Register of issued licenses for wholesale medical devices (wholesale register);
• Wholesale register that imports medical devices from non-EU countries (Importers Register); and
• Register of specialized stores of medical devices (Register of specialized stores)

The wholesale register, the Register of the importer and the Register of specialized stores, are in electronic form established and maintained by the Serbian Chamber of Commerce and Publisher on its website.

This Rulebook is adopted for the implementation of the solutions provided by the Medical Devices Act.

The data that is registered with the Chamber of Commerce in the mentioned registers shall be submitted by the Ministry when issuing, renewing, amending, supplementing or revoking the wholesale or retail license.

The listed entities and other legal entities or individuals who have an unquestioning legal interest in the above mentioned data, can obtain a certificate on the data kept in the register from the Chamber of Commerce.