Have you thought about who is responsible for the quality and safety of imported goods? In Ukraine, this role belongs to the Authorized Representative. This is a legal entity or an individual entrepreneur who has residency.

The presence of an authorized representative for any non-resident manufacturer is a requirement of Ukrainian legislation. Therefore, one of the first steps in the process of certification of medical products or cosmetics is the appointment of the authorized representative of the manufacturer in Ukraine. The authorized representative acts as an official intermediary between the producer and the Ukrainian market, including with state institutions responsible for market surveillance.

An Authorized Representative has certain duties. These duties are defined by the Technical Regulations and legislative acts:

• be responsible for the products in circulation;
• keep technical documentation for 5-15 years from the moment of release of the last product;
• participate in inspections by market surveillance authorities;
• perform post-marketing surveillance and inform about precedents;
• authorize importers and control gray imports;
• pay fines.

Usually, foreign manufacturers choose an authorized representative according to their own requirements and preferences. This can be an existing distributor or an independent company such as Miasphera. 

Let’s consider both cases in more detail.

Situation 1: The authorized representative is a dealer-importer

If the authorized representative is a dealer-importer, the manufacturer is more dependent on its conditions. In this case, the representative-dealer often acts in his own interests, closing the supply and sales to himself and limiting the rights of the dealership to other companies. In addition, he has an additional competitive advantage – his name, as an Authorized Representative, is present on the labeling or on the instructions of all products.

Situation 2: The authorized representative is a dealer-importer

If the Authorized Representative is a company that is not involved in the sale of products, the manufacturer can independently choose any number of dealers with whom he wants to cooperate.

Important clarification! Each type of medical device must be associated with only one Authorized Representative.

As you can see, the last option has more advantages for the manufacturer, as it allows you to regulate the number of dealers and grant the right to import and distribute your products to other companies.

Miasphera offers independent outsourcing services of the Authorized Representation, because we have many years of experience.

We work with a wide range of medical, cosmetic, food and veterinary products and always keep our finger on the pulse of legislative innovations.

Contact us and take an important step towards a successful start on the Ukrainian market!