JERELO provides full range of regulatory consulting services regarding circulation of medical products for both international and Ukrainian medical device companies.
If your company is going to sell medical devices in Ukraine, your products will need to comply with Ukrainian regulation requirements on medical devices and some other applicable regulations and legislation.
It is important to mention, that apart from technical regulations on medical devices (No. 753, 754, 755), the sphere of medical devices is governed by numerous other legislation provisions such as the Law of Ukraine “On General Safety of Non-Food Products”, The Law of Ukraine “On the State Market Supervision and Control of Non-Food Products”. In some other cases, in regard of particular medical devices, there are some others additional technical regulations applicable.
It’s also worth mentioning that besides the numerous regulations applicable, a constant regulatory and legislative changes can become one of the most troublesome challenges facing medical device companies seeking approval of a new product.
Thus it’s a complex process of medical products delivery on the market, which requires special knowledge and comprehensive understanding of the relevant legislation.
This work implies cooperation with the Authorized representative in the territory of Ukraine while drafting application forms, developing labeling for Ukrainian market, interaction with the conformity assessment body, consulting on issues of import and placing medical products on the market and so on.
JERELO provides expertise for all aspects of the medical device regulatory approval cycle and always aware of the best working conformity route for your Company.
With the help of JERELO you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements.
Special attention should be paid to class I medical devices self-declaration procedures. Despite the simplified compliance procedure for class I medical devices (non-sterile, non-measuring), there are still some mandatory requirements of applicable technical regulations to be performed. In order to conduct self-declaration correctly and comply with all requirements of technical regulation, JERELO provides services for class I medical devices compliance.
For more information, please contact us:
☎ +38 095 692 26 08
For any additional questions, you may always contact our specialists by phone +38044 360 30 11.