Streamlining Medical Device Export Procedures in Serbia
In the Republic of Serbia, the wholesale trade of medical devices has undergone significant changes due to the implementation of the new Law on Medical Devices. These changes, which took effect on December 1, 2017, have streamlined the import and export procedures for medical devices, making international trade more accessible and efficient.
Medical Device Import/Export Permits:
According to Article 70 of the new Law, wholesale trade of medical devices, including import, export, procurement, storage, and distribution, can only be conducted by legal or natural persons with a permit issued by the Ministry of Health. Manufacturers based in Serbia with permits for manufacturing can also conduct wholesale trade of medical devices from their own production program. To prove the right to import or export medical devices, specific documents such as permits for wholesale trade or manufacturing must be provided.
Import/Export of Registered Medical Devices:
For registered medical devices, it is necessary to submit the registration certificate issued by the Agency for Medicines and Medical Devices of Serbia (ALIMS) along with the required permits. Import/export of registered medical devices can be carried out even after the expiration of the registration certificate, as per specific provisions mentioned in the new Law.
Import/Export of Unregistered Medical Devices:
Medical devices not registered in Serbia can be imported with approval from ALIMS, and based on this approval, they can also be exported. This applies to cases such as donations, scientific research, emergencies, or use for specific patients or patient groups.
Export of Medical Devices Undergoing Clinical Trials:
The export of medical devices undergoing clinical trials is carried out based on documents related to their import, along with a statement from the principal investigator confirming they are unused quantities.
Import/Export of Medical Devices for Trade Fairs, Exhibitions, etc.:
Medical devices intended for display at trade fairs, exhibitions, or presentations can be imported/exported by persons registered for wholesale trade of medical devices. However, these devices need to be prominently labeled to indicate that they do not comply with basic requirements.
Import/Export of Medical Devices with Specific Serial Numbers for Repair:
Medical devices with specific serial numbers can be temporarily exported for repair, and the import of the repaired devices (re-import) does not constitute a sale under the new Law.
Import/Export of Custom-Made Medical Devices:
Custom-made medical devices for specific patients can be imported/exported by individuals with permits from the Ministry of Health. Documentary evidence of the medical device’s purpose and a healthcare professional’s order specifying its design characteristics are required.
The new Law on Medical Devices in Serbia has significantly simplified the import and export procedures for medical devices. Wholesale trade of medical devices is now exclusively conducted by entities with proper permits issued by the Ministry of Health. Additionally, specific guidelines for the import/export of registered, unregistered, custom-made, and clinically tested medical devices have been provided, making international trade more accessible and efficient for businesses in the medical device industry.
PS. It is essential for companies engaged in medical device trade to comply with the provisions of the new Law to facilitate smooth and compliant operations in the country.
📢 Notification: To get detailed information on the topic “Streamlining Medical Device Export Procedures: Ministry of Health’s New Regulations Simplify International Trade,” please visit the following link: https://statt.rs/streamlining-medical-device-export-procedures-ministry-of-healths-new-regulations-simplify-international-trade/