This year we attended OTWorld in Leipzig, the world’s leading trade show for prosthetics, orthotics and rehabilitation technology. We came to meet manufacturers considering the Ukrainian market, and we left with a clear picture of what international companies actually want to know before entering it.
Here are the questions that came up most often, and our short answers.
Can we sell directly in Ukraine?
Not without a local Authorized Representative. Under Ukrainian regulation, a foreign manufacturer cannot legally place a medical device on the market without an Authorized Representative (AR) established in Ukraine. This is the first step regardless of your commercial model: whether you plan to work through distributors, supply prosthetic workshops directly, or both. Appointing an AR is what makes everything that follows legal.
How big is the Ukrainian market, really?
Larger than most manufacturers expect, and growing. Through the state reimbursement programme alone, over 420,000 rehabilitation devices were supplied in 2025, with prostheses a key segment. The number of patients being fitted is growing roughly 20% year on year. Few domestic workshops serve this rising demand, which drives steady demand for imported components, modules and finished devices.
How long does market entry take?
It depends on device class. For Class I and custom-made devices, the route is a self-declaration at the authority — typically around ten business days once documentation is ready. For Class IIa and higher, conformity assessment at a designated body takes roughly one to two and a half months, depending on whether the device already carries CE marking.
Is Ukraine changing its regulation?
Yes. Ukraine is transitioning from its current Technical Regulation No. 753 (equivalent to the EU’s older MDD) toward an MDR-based framework, with new infrastructure — UDI, the EMDN nomenclature, a national device database — rolling out through 2027–2029. For manufacturers, this means the market is modernising and aligning with EU practice. Entering now, with documentation kept current, avoids a scramble later.
Thinking about Ukraine?
If you met us at OTWorld or wish you had — we’re happy to walk you through what entry looks like for your specific product. Med Quality acts as your Authorized Representative in Ukraine, so you can sell here without setting up a local entity.
Book a free 15-minute regulatory assessment at medquality.com.ua.
