Customs clearance of medical devices
Importing medical devices has its own peculiarities, which is why their customs clearance often causes difficulties for inexperienced importers. Based on resolutions and decisions, the customs authorities may grant tax benefits for medical products.
Errors in the documents can lead to delays in the preparation or the need to label medical devices, which entails additional costs for cargo storage and payment of customs duties without benefits.
The government strictly regulates and controls the import of medical devices.
According to the law, medical devices are subject to a reduced VAT rate of 7%. However, it is subject to compliance with the requirements of the Technical Regulations on Medical Devices, as well as a number of additional conditions.
The 7% VAT rate may be applied if the goods are medical devices, which is confirmed by one of the following documents
- a certificate of conformity required by the technical regulations for medical devices;
- a clinical trial authorization.
The inclusion of goods in the State Register of Medical Equipment and Medical Devices is not required from 01.07.2017 due to changes in legislation.
To apply the 7% VAT rate, it is necessary to comply with the requirements set forth in the technical regulations, such as the availability of a declaration of conformity, labeling with the conformity mark and inclusion of responsible persons in the relevant register.
Requirements for labeling medical devices
The following laws regulate the labeling of medical devices:
- Law of Ukraine No. 1023-XII “On Protection of Consumer Rights”;
- Law of Ukraine No. 2736-VI “On General Safety of Non-Food Products”;
- Law of Ukraine No. 5029-VI “On the Principles of the State Language Policy”;
- Resolution No. 753 “On Approval of the Technical Regulations on Medical Devices” and others.
The labeling of medical devices must contain the mark of compliance with technical regulations, the name of the product, the country of origin, and the data of the manufacturer and authorized representative. The text must be in Ukrainian, translation is allowed.
Classification of products and conformity assessment procedures
Medical devices are classified by classes, and each class has different conformity assessment procedures:
- Class I medical devices and in-vitro diagnostic devices are subject to a “self-declaration” procedure without the involvement of a designated authority.
- In-vitro diagnostic devices for self-monitoring require the involvement of a designated body at the verification stage.
- For sterile devices and active implantable medical devices, an audit of the manufacturer or recognition of the EU certificate is required.
A professional approach to the transportation of medical devices is essential for successful imports.
Grand Logistics Company offers comprehensive solutions for the international transportation of medical devices, taking into account all the nuances of their customs clearance and labeling. We guarantee reliable and fast delivery in compliance with all legal requirements. Contact us today and order the transportation of medical devices from professionals!
