Who is an Authorized Representative?

 

The Authorized Representative serves as an intermediary between the foreign manufacturer and Ukrainian authorities, including conformity assessment bodies, market surveillance authorities, customs, and consumers. Their responsibilities include:
 

  • Maintaining technical documentation for a specified period.
  • Participating in market surveillance inspections.
  • Reporting product-related incidents.
  • Authorizing importers and combating “gray” imports.

 
Each medical device type or model may have only one Authorized Representative, though a manufacturer can appoint different representatives for different products.
 
Choosing an Authorized Representative
An Authorized Representative can be an importer, distributor, or a third-party entity unrelated to the supply chain. Some manufacturers prefer a third-party Authorized Representative to avoid conflicts of interest and maintain neutrality in interactions with all distributors.
 
 

Formalizing Authorization.

 
Appointing an Authorized Representative is formalized through a power of attorney and/or a contract. A power of attorney is convenient for submission to external organizations but transfers rights unilaterally. A contract, however, defines rights and obligations of both parties, limits the Authorized Representative’s liability, and establishes interaction procedures.
 
 

How ProPravo Can Help?

 
Our law firm, ProPravo, offers comprehensive services for appointing and supporting an Authorized Representative in Ukraine:

 

  • Preparation and legalization of required documents.
  • Consultations on Ukrainian legislative requirements.
  • Support in interactions with state authorities.
  • Ensuring product compliance with market requirements.

 
 
Contact us for professional assistance and to ensure the legal entry of your products into the Ukrainian market.