Streamlining Medical Device Export Procedures: Ministry of Health’s New Regulations Simplify International Trade
Wholesale trade of medical devices is carried out by legal or natural persons who have been issued a permit by the Ministry of Health for conducting wholesale trade or parts of wholesale trade, specifically in the case of import/export.
“In the “Official Gazette of the Republic of Serbia,” No. 105/2017, the Law on Medical Devices (hereinafter: the new Law) was published, which came into force on December 1, 2017, and has been applicable since December 2, 2018. As of the date of the implementation of this law, the Law on Medicines and Medical Devices (“Official Gazette of the Republic of Serbia,” No. 30/2010 and 107/2012 – hereinafter: the old Law) regarding medical devices for human use ceases to be valid.
The Customs Administration addressed the Ministry of Health with a request for interpretation of certain provisions of the new Law to resolve certain ambiguities. Additionally, the Ministry of Health was asked to state its position on certain matters that were not explicitly regulated by the old Law and were also not explicitly regulated by the new Law. By act number: 011-00-253/2018-06 of December 13, 2018, the Ministry of Health provided the Customs Administration with an interpretation of certain provisions of the new Law. Consequently, we hereby inform you of the following.
Right to import/export medical devices (permit for wholesale trade of medical devices and permit for manufacturing medical devices)
According to Article 70 of the new Law, wholesale trade of medical devices (which includes import, export, procurement, storage, and distribution of medical devices) is carried out by legal or natural persons who have been issued a permit by the Ministry of Health for conducting wholesale trade or parts of wholesale trade, specifically in the case of import/export.
Furthermore, a manufacturer based in the Republic of Serbia, to whom the Ministry of Health issues a permit for manufacturing in accordance with the new Law, can conduct wholesale trade of medical devices from its own production program. Additionally, a manufacturer based in the Republic of Serbia, to whom the Ministry of Health does not issue a permit for manufacturing in accordance with the new Law, is required to submit an application for the issuance of a permit for wholesale trade of medical devices from its own production program.
In order to prove the right to import/export medical devices, one of the following documents must be provided:
- Permit for conducting wholesale trade of medical devices or parts of wholesale trade – import/export, or
- Permit for manufacturing issued to a domestic manufacturer (for products listed in that permit), or
- Permit for wholesale trade of medical devices from its own production program.
In addition to the aforementioned documents issued by the Ministry of Health, when importing/exporting medical devices, documents proving that a specific medical device (registered or not) can be imported or exported from the Republic of Serbia must also be submitted. These documents are issued by the Agency for Medicines and Medical Devices of Serbia (ALIMS).
The specific documents required by ALIMS in the customs procedure depend on the individual case, which is further described in the subsequent points of this document.
Import/export of registered medical devices
In addition to the documents issued by the Ministry of Health, which prove the right to import/export of a particular person, when importing/exporting registered medical devices, it is necessary to submit the registration certificate of the medical device issued by ALIMS.
The new Law prescribes that medical devices can be placed on the market or used only if they have undergone conformity assessment. Since conformity assessment of medical devices is only one of the prerequisites for issuing a registration certificate for medical devices, documents proving that conformity assessment has been carried out do not need to be submitted when importing/exporting the same.
2.1. Import/export of registered medical devices after the expiration of the registration certificate issued in accordance with the old Law
The validity period of the registration certificate of medical devices (registration certificate) issued in accordance with the old Law is prescribed by the transitional and final provisions of the new Law. Specifically, Article 133, paragraph 1 of the new Law prescribes that the registration certificate for a medical device issued in accordance with the old Law is valid until the expiration of the period for which it was issued. Since the new Law does not prescribe a period in which the import/export of medical devices can be carried out after the expiration of the registration certificate of the medical device (as was the case according to the old Law), the import and export of medical devices can be carried out until the expiration of the period stated in the registration certificate.
2.2. Import/export of registered medical devices after the expiration of the registration certificate issued in accordance with the new Law
Article 52 of the new Law prescribes that medical devices registered in accordance with the new Law can be on the market for 90 days from the date of the expiration of the registration certificate. The same article also stipulates that within this period, the import of medical devices for which the registration certificate has expired cannot be performed unless a request for its extension has been submitted.
Therefore, medical devices for which the registration certificate issued under the new Law has expired can be exported within 90 days from the date of the expiration of the registration certificate, along with the submission of the registration certificate that has expired.
During the specified period, they can also be imported if a request for the extension of registration has been submitted to the Medicines and Medical Devices Agency. In this case, in addition to the expired registration certificate, a confirmation from ALIMS of the completeness of the request for the extension of registration must be submitted.
2.3. Import/export of registered medical devices in cases where the importer/exporter is not the holder of the registration certificate for the medical device
If the importer/exporter is not the holder of the registration certificate for the medical device, it is necessary, in addition to the aforementioned documents, to submit, when importing/exporting medical devices, an authorization from the holder of the registration certificate (manufacturer of medical devices or authorized representative of the manufacturer) granting authorization/consent to the specified importer/exporter to carry out the import/export of specific medical devices.
Import/export of unregistered medical devices
Medical devices that are not registered in the Republic of Serbia, in accordance with the provisions of the new Law, are imported with the approval of ALIMS. These medical devices are imported in cases such as when they are intended for a specific patient or group of patients, when imported as donations or humanitarian aid, for scientific research, or in cases of emergency.
As the Ministry of Health, through the aforementioned act, informed the Customs Administration that it is of the opinion that the export of these imported medical devices can be carried out based on the same approval, we hereby inform you that the export of these unregistered imported medical devices can be done based on that same approval from ALIMS.
Export of medical devices subject to contract manufacturing and export of medical devices manufactured exclusively for export
The Ministry of Health informed the Customs Administration that, in accordance with the provisions of Article 63 of the new Law, legal and natural persons on the territory of the Republic of Serbia who perform manufacturing or part of the manufacturing of a medical device on behalf of a manufacturer outside the territory of the Republic of Serbia (contract manufacturing), as well as legal and natural persons who manufacture or part of the manufacture of a medical device exclusively for export, are obliged to report this manufacturing activity to the Ministry
Export of medical devices subject to contract manufacturing and export of medical devices manufactured exclusively for export
The Ministry of Health has informed the Customs Administration that, in accordance with the provisions of Article 63 of the new Law, legal and natural persons on the territory of the Republic of Serbia who carry out manufacturing or part of the manufacturing of a medical device on behalf of a manufacturer outside the territory of the Republic of Serbia (contract manufacturing), as well as legal and natural persons who manufacture or part of the manufacture of a medical device exclusively for export, are obliged to report this manufacturing activity to the Ministry of Health, and no manufacturing permit is issued for this activity.
As the Ministry of Health believes that the export of these products can be done based on evidence of contract manufacturing (e.g., a contract), when exporting the mentioned medical devices, in addition to the permit mentioned in point 1 of this document, it is necessary to provide evidence of contract manufacturing.
Return of medical devices exported from the Republic of Serbia
In the case of the return of medical devices that were exported from the Republic of Serbia, the Ministry of Health is of the opinion that their import can be carried out by submitting the documents based on which their export was performed, along with the consent of the manufacturer or the authorized representative of the manufacturer.
Therefore, in this case, in addition to the documents based on which the export of medical devices was carried out, it is necessary to provide the consent of the manufacturer or the authorized representative of the manufacturer.
Import of spare parts for medical devices
Regarding the import of spare parts for medical devices, the Ministry of Health stated in the aforementioned act that if a product is designated or otherwise specified as a spare part for medical devices, the provisions of the new Law do not apply, and the same does not apply to the case when the spare part is also a medical device.
Therefore, when importing spare parts for medical devices, it is necessary to determine whether the specific product being imported is also a medical device or not.
If the manufacturer has not declared a specific product as a spare part, but there is a suspicion that it may be a medical device, ALIMS, as the body responsible for determining the status of products in terms of whether they are medical devices or not, must provide an opinion on this matter. In that case, when importing the respective product, it is necessary to provide either the opinion of ALIMS that the specific product is not a medical device or the registration certificate of the medical device, which is also issued by ALIMS.
Import/export of medical devices undergoing clinical trials, as well as drugs and medical devices used in conducting clinical trials of medical devices
The import of a medical device undergoing clinical trials, as well as products (drugs and medical devices) used in conducting clinical trials, is carried out by a person who has obtained a wholesale trade permit for medical devices from the Ministry of Health, based on the approval of the clinical trial or the approval for the import of those products, issued by ALIMS.
An integral part of the ALIMS approval for conducting a clinical trial is the list of products (medical devices and drugs) used in the clinical trial (hereinafter: List), which includes the name and quantity of these products.
7.1 Import of medical devices and drugs imported for the purposes of the clinical trial of a medical device, which are covered by the List
If a product covered by the List (which is an integral part of the ALIMS approval for conducting a clinical trial) is imported for the purposes of the clinical trial of a medical device, ALIMS does not issue a separate approval for the import of these products, and the import is carried out by submitting the approval for conducting the clinical trial of the medical device.
7.2 Import of medical devices and drugs not covered by the List, which are imported for the purposes of the clinical trial of a medical device
In the case where there is a subsequent need to import a certain product (medical device, drug) for the purposes of the clinical trial of a specific medical device, for which the approval for conducting the clinical trial has already been issued, and that product is not explicitly listed in the List (i.e., it is not covered by the List), ALIMS issues a separate approval for the import of that product. In this case, when importing products not covered by the List, in addition to the ALIMS approval for conducting the clinical trial of the medical device, it is necessary to provide an additional ALIMS approval for the import of the specific product.
7.3 Export of unused quantities of medical devices that were part of a clinical trial
According to the opinion of the Ministry of Health and in accordance with the new Law, the export of unused quantities of medical devices that were part of a clinical trial is carried out based on the documents on which they were imported into the Republic of Serbia and a statement from the principal investigator that these are unused quantities.
The same applies to other products used in the clinical trial of medical devices (drugs, other medical devices).
7.4 Labeling of medical devices undergoing clinical trials
Although Article 35 of the new Law stipulates that a medical device undergoing clinical trials must be additionally labeled with the words “for clinical trial,” according to the opinion of the Ministry of Health, there is no need for the Customs Administration to verify this information, considering that the approval of the clinical trial, including the assessment of whether the medical device is labeled in the prescribed manner, is carried out by ALIMS.
Import/export of medical devices intended for trade fairs, exhibitions, presentations, etc.
In accordance with Article 19 of the new Law, a medical device intended for display at business fairs, exhibitions, presentations, etc., does not need to meet the requirements prescribed by the new Law and regulations adopted for its implementation, provided that it is prominently labeled with a warning that the medical device does not comply with basic requirements and that its sale or use for any purpose is prohibited until it complies with the basic requirements.
Therefore, when importing/exporting these medical devices, it is not necessary to provide a registration certificate or approval for the import of unregistered medical devices. However, according to the opinion of the Ministry of Health, their import/export as part of wholesale trade can only be carried out by persons registered for wholesale trade of medical devices, and in this regard, in these cases, it is necessary to provide a permit for wholesale trade of medical devices or parts of wholesale trade – import/export.
Import/export of medical devices with specific serial numbers for repair
Article 69 of the new Law stipulates that the export for repair of a medical device with a specific serial number, which was in use in the Republic of Serbia, and the import of the same medical device with the same serial number does not constitute a sale within the meaning of the said Law.
Furthermore, the Ministry of Health provided an opinion that this procedure can also apply to temporary import for the repair of a medical device.
Therefore, in accordance with the opinion of the Ministry of Health, temporary export/temporary import of a medical device with a specific serial number for repair, as well as its return after repair (re-import/re-export), can be carried out without providing the documents prescribed by the new Law.
Import/export of medical devices custom-made for a specific patient
The import/export of medical devices custom-made for a specific patient, according to the opinion of the Ministry of Health, can be carried out by persons who have obtained a permit from the Ministry of Health (as described in point 1 of this document), provided that they have evidence of the purpose of the specific medical device – an order from the appropriate healthcare professional who, at their own responsibility, specifies the design characteristics of that medical device and designates it for a specific patient (e.g., dental prosthetics, etc.).
Transit of medical devices and re-export of medical devices (purchase of goods abroad for their sale abroad)
According to the provisions of Article 69 of the new Law, the transit and import for export of a medical device do not constitute a sale within the meaning of that Law. Therefore, when conducting customs procedures in these cases, it is necessary to comply with customs regulations.
Storage of medical devices
Article 71 of the new Law stipulates that a person engaged in wholesale trade of medical devices must meet the conditions regarding space, equipment, personnel, as well as other conditions prescribed by this Law and regulations adopted for its implementation. The same article also stipulates that the aforementioned conditions must be met by the customs warehouse that conducts activities in accordance with customs regulations and stores medical devices.
The Ministry of Health provides an opinion on the fulfillment of the aforementioned conditions, based on which the customs authority issues an approval for the management of the warehouse.
Trade of medical devices that are also precursors or low-active controlled substances
In addition to all the above, it is necessary to consider the following.
If certain medical devices fall within the competence of the Ministry of Health not only under the Law on Medical Devices but also under the Law on Substances Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances (“Official Gazette of the Republic of Serbia,” No. 107/2005), i.e., precursors, or the Law on Psychoactive Controlled Substances (“Official Gazette of the Republic of Serbia,” No. 99/2010 and 57/2018), the import/export/transit of these medical devices must comply with the conditions prescribed by these laws as well.