Trade of medical devices in Serbia

The trade of medical devices is another category of regulated trade that is regulated by strict rules and a series of conditions whose fulfillment is required.

The Law on Medical Devices (“Official Gazette of the RS”, No. 105/2017 “Law“) appears as the basic law, while the sphere of trade is elaborated in detail by a series of rulebooks which elaborate both the basic rules and the classification of medical devices and additional conditions for the trade of certain categories of medical devices.

As it could be directly concluded at the very beginning, the permission of the Ministry of Health is necessary for the trade of medical devices. However, in order for a medical device to be placed on the market, it is necessary for it to be subjected to registration with the Agency for Medicinal Products and Medical Devices (“ALIMS“), except for those medical devices that can be placed on the market without registration and are in a significant minority compared to the before mentioned.

Registration of a medical device

The procedure and conditions for registration are prescribed by the Law and the Rulebook on the registration of medical devices (“Official Gazette of RS”, No. 84/2018, 58/2021). Actively legitimized to initiate the procedure of registration of a medical device before ALIMS is:

1) manufacturer of a medical device (manufacturer with a registered office in the Republic of Serbia or a representative office or branch of a foreign manufacturer with a registered office in the Republic of Serbia);

2) authorized representative of the manufacturer.

The applicant for registration of a medical device must have a person responsible for documentation, employed full time for work in the process of registration, amendment, supplementation, extension or deletion of registration of a medical device in accordance with the Law.

The specified responsible person must have completed medical, dental, pharmaceutical, technological, electro-technical, mechanical, chemical or legal faculty in accordance with the Law.

The applicant must have a person responsible for vigilance and monitoring of medical devices on the market, a full-time employee who performs vigilance work and who has completed medical, dental, pharmaceutical, technological, electro-technical, mechanical, chemical or other appropriate faculty. depending on the type of medical device, as well as additional education in the field of vigilance.

Exceptionally, the applicant may have one person responsible for documentation and vigilance, depending on the number of represented classes and categories of medical devices, planned turnover, as well as the benefits of education and experience of the responsible person, which is decided by the Agency in the medical device registration procedure, extensions or amendments to the registration.

Medical devices are registered according to category and class, with the submission of a declaration and certificate of conformity of the medical device, ie that the properties of the medical device are in accordance with the basic requirements prescribed by the Law and Rulebook on basic requirements for medical devices (“Official Gazette of RS”, No. 105 / 2017). In addition to the main conditions, which are essential for the registration of a medical device, the Rulebook on registration of a medical device prescribes the submission of other evidence of compliance of the applicant with the mandatory regulations, which are listed in detail in the cited rulebook.

Trade authorization of medical devices

The trade of medical devices includes the wholesale and retail trade of medical devices in accordance with the Law and the relevant regulations governing the wholesale and retail trade of medical devices.

  • Wholesale

Wholesale of medical devices in the sense of the Law is the purchase and further sale to natural or legal persons to perform their professional or registered activity, and includes import, export, procurement, storage and distribution, except for issuing medical devices to patients for their personal needs.

The trade may be performed by a legal or natural person who meets the conditions prescribed by the Law and the Rulebook on Wholesale of Medical Devices (“Official Gazette of RS” No. 84/2018).

A manufacturer with a registered office in the Republic of Serbia to whom, in accordance with the Law, the Ministry of Health issues a production permit, may carry out wholesale trade in medical devices from its own production program.

Otherwise, a manufacturer based in the Republic of Serbia to whom the Ministry does not issue a production license in accordance with the Law is obliged to submit a request for the issuance of a wholesale license for medical devices from its own production program.

Wholesale is obliged to perform wholesale trade of medical devices in accordance with the license for wholesale trade of medical devices and guidelines of good practice in the distribution of medical devices, which are prescribed by the Rulebook on guidelines of good practice in the distribution of medical devices (“Official Gazette of RS” no. 94/2018).

Wholesale trade of medical devices may be performed by a legal or natural person who meets the requirements in terms of space, equipment, staff, as well as other requirements.

Wholesale is required to have:

1) the person responsible for the reception, storage, safekeeping and delivery of medical devices;

2) appropriate space, equipment and staff, as well as other conditions for wholesale trade in medical devices.

The wholesaler is obliged to conclude a full-time employment contract with the mentioned persons.

Wholesale is obliged to ensure constant availability of responsible persons, or it can also appoint other persons with appropriate qualifications who have the authority to perform the activities of that person.

The application for the issuance of a license for the wholesale trade of medical devices shall be submitted to the Ministry in writing, which shall contain:

1) name and seat of the legal or natural person and place of storage of medical devices;

2) a list of classes and categories of medical devices for which a wholesale trade is sought;

3) name of the person responsible for wholesale trade of medical devices;

4) a statement on the territory of supply of medical devices;

5) plan for urgent withdrawal of medical devices from the market.

The Ministry shall issue a license for wholesale distribution of medical devices no later than 60 days from the day of receipt of the request for issuance of a license for wholesale distribution of medical devices, if the conditions prescribed by the Law and cited bylaws are met. The permit is issued for a period of five years. The decision on the request for the issuance of a permit is finally in the administrative procedure, so an administrative dispute can be initiated against it.

The Register of issued licenses for wholesale trade of medical devices in electronic form is established and maintained by the Chamber of Commerce of Serbia.

  • Retail

Retail sale of medical devices is performed in pharmacies and private practices that perform activities in accordance with the Law, and the Law on Health Care (“Official Gazette of RS”, No. 25/2019).

Retail sale of medical devices is also performed in specialized stores of medical devices in accordance with the Law and the Rulebook on retail sale of medical devices in specialized stores (“Official Gazette of RS”, No. 65/2018).

Certain types of medical devices may also be sold at other closed points of sale where retail trade is carried out in accordance with the regulations governing trade.

The list of medical devices that can be sold in other places referred to in paragraph 8 of this Article is published on the official website of ALIMS, and the register of specialized stores of medical devices, as well as in the case of wholesale, is established and maintained in electronic form by the Serbian Chamber of Commerce.

Retail sale of medical devices can be performed in a specialized store if:

1) is manufactured by a legal or natural person who has a license for the production of that medical device;

2) is registered in accordance with the Law;

3) the conformity of the medical device with the basic requirements has been assessed in accordance with the Law and regulations adopted for its implementation;

4) is marked in accordance with the Law;

5) its lifespan marked on the packaging has not expired, ie if non-compliance with the basic requirements has not been determined in accordance with the Law and regulations adopted for its implementation;

6) trade in medical devices is performed in accordance with the Law.

Only those classes and categories of medical devices that can be issued or sold in a specialized store in accordance with the purpose determined by the manufacturer and the certificate of conformity of the medical device may be sold in a specialized store. Medical devices cannot be issued or sold contrary to all of the above.

The cited rulebook on retail sale of medical devices in specialized stores prescribes appropriate conditions in terms of space, staff, plan for urgent withdrawal of medical devices from the market, the sign of a specialized store.

In addition to the evidence on all of the above, the following is submitted to the Ministry of Health with the request for a permit for retail trade in a specialized store:

1) business name and registered office of a legal or natural person who performs retail trade in medical devices;

2) identification number;

3) class and category of medical devices that are the subject of the license for retail sale of medical devices;

4) address of the specialized store;

5) name and contact (mobile phone, e-mail) of the person responsible for the retail sale of medical devices.

The Ministry shall issue a decision to issue a license for retail trade in a specialized store within 60 days from the day of receipt of the request for issuance of a license submitted in writing. The permit is issued for a period of five years. The decision on the request is finally in the administrative procedure and an administrative dispute can be initiated against it.