Law on Medical Devices

Trade of medical devices for human use

Trade in medical devices for human use (from now on: medical device) includes wholesale and retail sale of medical devices following the provisions of the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and regulations adopted for its implementation.

Concept and classification of medical devices

Medical device (general) means any instrument, apparatus, appliance, software, implant, reagent, material and other product used alone or in combination, including software provided by the manufacturer for diagnostic or therapeutic purposes and which is software support necessary for its proper use in people intended by the manufacturer, and is used for:

  1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
  2. diagnosis, monitoring, treatment, alleviation or compensation of injury or disability
  3. investigation, replacement or modification of the anatomy or physiological or pathological process and state
  4. providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
  5. control or support of conception
  6. products intended for cleaning, disinfection or sterilization of medical devices.

The medical device, which has been described above does not fulfil, its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.

The classification of medical devices shall be carried out by the notified i.e. appointed body, in accordance with the essential requirements, except for medical devices of Class I and other in vitro diagnostic medical devices, whose classification is carried out by the manufacturer.

According to provisions of the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) types of medical devices are:

  1. General medical devices
  2. In vitro diagnostic medical devices
  3. Active implantable medical devices.

The general medical devices according to the degree of risk for the users are divided into:

  1. Class I – medical devices with low degree of risk for the user
  2. Class IIa – low to medium degree of risk for the user
  3. Class IIb – medium to high degree of risk for the user
  4. Class III – medical devices with a high degree of risk for the user.

The wholesale of medical devices

The wholesale of medical devices in the sense of the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) is the purchase and further sale to natural or legal persons for the performance of their professional or registered activity, including import, export, procurement, storage and distribution, except for the issue of a medical device to the patient for their personal needs.

The turnover, or part of the wholesale distribution of medical devices, can be performed by a legal or natural person that meets the requirements prescribed by the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation (hereinafter: wholesale).

Wholesale may entrust certain tasks of the marketing of medical devices to a large wholesale market.

Certain tasks of wholesale of medical devices, in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation, may also be entrusted by wholesale to a legal or natural person who is not wholesale.

A manufacturer based in the Republic of Serbia who, in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017), may issue a manufacturing licence to a large number of medical devices from his own manufacture program. A manufacturer with a head office in the Republic of Serbia who, in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017), does not issue a manufacture licence, is obliged to apply for a marketing authorisation for a wide range of median funds from their own manufacture programme.

Wholesale is obliged to carry out the wholesale distribution of medical devices in accordance with the licence for wholesale medical devices and the guidelines for good practice in the distribution of medical devices.

The provisions of the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the bylaws adopted for its implementation regulating the wholesale distribution of medical devices shall apply mutatis mutandis to wholesale medical supplies from donations or humanitarian aid.

Requirements for issuing a marketing authorization for medical devices in bulk

The Rulebook on Wholesale of Medical Devices (“Official Gazette of RS”, No. 84/2018) prescribes the conditions for performing the trade, i.e. part of the wholesale trade of medical devices, the manner and conditions for entrusting business to another wholesale or another legal or natural person which is not wholesale, the method of issuance, as well as the content of the license for the wholesale trade of medical devices.

The Ministry of Health shall issue a licence for the wholesale distribution of medical devices to legal or natural person who meets the requirements regarding space, equipment, personnel, as well as other requirements prescribed by the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation.

Wholesale shall have:

  • The person responsible for receiving, storing, keeping and delivering medical devices with which wholesale shall be obliged to conclude a full-time employment contract.
  • Adequate space, equipment and staff, as well as other conditions for the wholesale of medical devices.

Application for issue of a licence for the wholesale distribution of medical devices

The application for the granting of a marketing authorisation for wholesale medical devices shall be submitted to the Ministry of Health in writing and shall contain at least:

  1. The name and seat of the legal or natural person and the place of storage of medical devices
  2. A list of classes and categories of medical devices for which the wholesale market requires permission
  3. The name of the person responsible for the wholesale distribution of medical devices
  4. Statement on the territory of supply with medical devices
  5. Plan for urgent withdrawal of medical devices from the market.

The Minister of Health shall prescribe more precisely the contents of the requests and documentation for the issue of a marketing authorisation for wholesale medical devices.

Issue a licence for the wholesale distribution of medical devices

The Ministry of Health shall issue a licence for the wholesale distribution of medical devices at the latest within 60 days from the date of receipt of the application for the issue of a marketing authorisation for wholesale medical devices, if the conditions prescribed by the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation are fulfilled.

Register of issued licences for wholesale medical devices

The Register of Licences issued for the wholesale distribution of medical devices (hereinafter: the Register of Wholesale) in electronic form is established and maintained by the Serbian Chamber of Commerce, as a trusted job.

The wholesale register that imports medical devices from non-EU countries (hereinafter: the Register of Importers) in electronic form is established and maintained by the Serbian Chamber of Commerce as a trusted job.

The Serbian Chamber of Commerce, at the request of wholesalers, or other legal or natural persons having an indisputable legal interest, shall issue a certificate on the data kept in the Register of Wholesale and in the Register of Importers.

Reasons for revocation of the licence for the wholesale distribution of medical devices

The Ministry of Health may issue a decision on termination of the decision whereby the wholesale licence is issued for wholesale trade, if wholesale:

  • Ceases to fulfil the conditions for the wholesale distribution of medical devices on the basis of which the decision prescribed by the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation has been issued
  • Fails to remedy deficiencies and irregularities in the work determined by the Ministry of Health in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation within a specified period
  • Fails to perform the obligation of continuous supply of the market with a medical device for which a wholesale permit has been issued, in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation
  • Submits a request for revocation of the wholesale licence
  • Performs the wholesale turnover of forged medical devices or if they do not inform the Ministry of Health, the Medicine and Medical Devices Agency of Serbia and the manufacturer or the authorised representative of the manufacturer about the sale of a medical device suspected of being forged or found to be falsified.

If the private customs warehouse for medical devices ceases to fulfil the conditions for storage of medical devices for which the licence has been issued in accordance with Article 71, paragraph 7 and 8 of the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017), the Ministry of Health shall inform the customs authority that issued the decision on the opening of the customs warehouse.

Retail trade of medical devices

Retailing

Retail trade of medical devices is carried out in pharmacies and private practice that performs activities in accordance with the law.

Retail medical devices are also sold in specialised medical equipment shops in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation. The Ministry of Health shall issue a license for performing retail trade to a specialised shop by the decision no later than 60 days from the date of receipt of the application for the issue of a licence submitted in writing. The register of specialised medical device shops in electronic form is established and maintained by the Chamber of Commerce of Serbia as an entrusted job.

Certain types of medical devices may also be sold at other closed retail outlets in accordance with the regulations governing trade. The list of medical devices that can be sold in other places shall be published on the official website of the Medicine and Medical Devices Agency of Serbia.

A manufacturer of custom manufactured medical devices manufactured by order (custom-made device) may issue a medical device without a marketing authorisation for medical devices issued by the Ministry of Health.

Retail conditions

A medical device may be in retail if:

  1. The conformity assessment has been carried out in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation
  2. Is registered in the Register of Medical Devices and manufactured by a legal or natural person registered in the Register of Manufacturers
  3. Is marked in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation
  4. The expiry date marked on the packaging has not passed and no non-compliance with the essential requirements has been established
  5. Retail medical equipment is carried out in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation.

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