- In which cases should an Authorized Representative in Ukraine be appointed?
- What are the responsibilities of the Authorized Representative?
- May I appoint a distributor as an Authorized Representative?
- How to guarantee the confidentiality of technical documentation for medical devices?
Do you want to bring your medical products to the Ukrainian market?
If you are a foreign manufacturer of medical devices and your company does not have a representative office in Ukraine, it is mandatory for you to appoint your Authorized Representative.
Pursuant to Ukrainian laws, an authorized representative is any legal entity or individual entrepreneur, resident of Ukraine or a representative office of a foreign business entity registered in accordance with the legislation of Ukraine, which/who has duly confirmed authority from the manufacturer to perform the duties established by technical regulations.
Your Authorized Representative is the interlink between you and national competent authorities, as well as consumers.
The Authorized Representative will:
– assist in conformity assessment procedures as required by applicable laws;
– be your contact person in Ukraine (name, address, contacts are indicated on each package of products);
– keep the technical documentation for the products, which must be submitted at the request of the competent authorities, if necessary;
– take any necessary measures in case of receiving notifications of incidents with medical devices.
It is possible to appoint your distributor as the Authorized Representative, but this practice is not recommended as most distributors are not prepared to perform the functions of an Authorized Representative.
It is wiser to choose an individual representative who is well acquainted, first of all, with any issues of regulatory policy and legislation in the matter of circulation of medical devices, and not with the issues of sales and marketing.
If you are still thinking about appointing a distributor or an independent company as an Authorized Representative, answer the following questions:
– Is your distributor aware of regulatory policies and legislation regarding the circulation of medical devices?
– Does your distributor monitor legislative changes in circulation of medical devices in order to inform you on such changes in due time?
– In case you have several distributors in Ukraine, are you sure there will be no conflict of interest when appointing one of distributors as the Authorized Representative, because the name and contact information of the Authorized Representative is placed on each package of the product?
– Are you sure that the distributor will be able to represent you before competent authorities?
– If your distributor does not know how to respond to requests from the competent authorities, does any of your company’s employees have such knowledge?
– Do you want the technical file for your products to be saved by the distributor?
Our company has implemented special documented methods to ensure the storage and guarantee the confidentiality of technical documentation entrusted by manufacturers for storage within performance of our functions of the Authorized Representative.
Thus, we guarantee the confidentiality of technical documentation for medical devices.