1. We offer a wide range of services that can be provided by an authorized representative of a medical device manufacturer. This means we can assist you in all stages of the medical device manufacturing and sales process.
2. Our services include registration of medical devices with relevant authorities, organization of production and supply, quality control, and certification. We can also provide advice on legal, medical, and financial issues related to the production and sale of medical devices.
3. With many years of experience working with medical devices, our team is ready to provide professional and practical assistance to authorized representatives of medical device manufacturers. We work with all classes of medical devices, including sterile, procedural kits, and medical devices for in-vitro diagnostics.
IF YOU HAVE ANY QUESTIONS, THE COMPANY’S EXPERTS WILL PROVIDE FREE CONSULTATIONS
If a medical device manufacturer is not based in Ukraine, they must appoint an authorized representative in the country who will ensure the exchange of information, interaction with market surveillance authorities, and storage of technical documentation as per the requirements of the law. An authorized representative may be a legal entity or an individual entrepreneur who is a resident of Ukraine.
In order to obtain the status of an authorized manufacturer representative, it is necessary to send a written power of attorney or agreement to a legal entity that will assume such obligations and represent the manufacturer’s interests in Ukraine.
The obligation to appoint an authorized representative applies to all medical devices:
Each medical device (type/model) must be associated with only one authorized representative, whose name and location must be indicated on the packaging of each medical device or in the instructions for use. The manufacturer may appoint several authorized representatives for different medical devices.
An authorized representative ensures the timely exchange of information, post-marketing surveillance, and communication between the manufacturer and conformity assessment bodies, market surveillance bodies, revenue and duties authorities, and consumers. They must participate in inspections by market surveillance authorities, report incidents and facilitate conformity assessment processes.
An authorized representative has many rights and obligations, including keeping technical documentation for at least 5 years, or for active products – for at least 15 years from the date of the last product release, participating in inspections by market surveillance authorities, paying fines for the manufacturer, performing post-marketing surveillance and reporting incidents, authorizing importers, blocking gray imports, etc.
An authorized representative is registered by the State Service of Ukraine on Medicines and Drugs Control. It is required for:
