Authorized representative for medical devices in Ukraine
The first step for a foreign manufacturer of medical devices planning to launch its products on the Ukrainian market is to appoint an authorized representative. This person or company, registered in Ukraine, acts as an official intermediary between the manufacturer and local regulatory authorities.
Why is this important?
The choice of an authorized representative is critical to ensuring that products comply with all requirements of Ukrainian legislation.
Role and responsibilities of an authorized representative agreement
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Legal responsibility
An authorized representative acts on behalf of the manufacturer, ensuring that products comply with Ukrainian regulations. He is also responsible for compliance with all legal requirements governing the circulation of medical devices.
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Post-market surveillance
The authorized representative monitors the safety and performance of products after they have been placed on the market. This includes collecting and analyzing data on possible side effects or incidents related to the use of the product.
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Documentation
The Authorized Representative keeps and maintains all necessary technical documentation, ensuring its availability for review by regulatory authorities. This includes certificates, test reports, and declarations of conformity
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Communication with government authorities
The authorized representative acts as the key contact person between the manufacturer and government authorities, such as the State Service of Ukraine on Medicinal Products. He is responsible for the timely submission of reports and responses to inquiries regarding the product.
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Legal information
In accordance with legal requirements, the authorized representative ensures that their contact information is available on the product label, packaging, and in the instructions for use.
Rights of an authorized representative agreement
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Initiation of conformity assessment
The authorized representative has the right to initiate conformity assessment procedures, submit the necessary documentation and product samples to the assessment bodies
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Negotiations
ensuring that the products comply with all requirements of Ukrainian legislation
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Termination of sales
In case of non-compliance or risks to consumers, the authorized representative has the right to initiate the withdrawal of products from the market
Conclusion of an authorized representative agreement
An official agreement between the manufacturer and the authorized representative clearly defines the responsibilities, rights, and functions of each party
We provide support - from conformity assessment to product monitoring