What Does Medical Device Registration in Ukraine Actually Cost? A Cost-Structure Guide for Manufacturers

The Ukrainian medical device market didn’t stop during the war. Demand shifted, it didn’t disappear: some purchasing moved into the Prozorro Market electronic catalog, and complex purchases like CT systems didn’t go away — in some segments they even grew. We covered this in more detail in “Ukrainian Medical Device Market During the War.” But however active the market is, every manufacturer eventually runs into the same question: what will this actually cost. The answer rarely comes down to one number.

RAA fee and CAB fee: two separate cost items

The cost of registration always has two parts: the fee for the regulatory consultant (RAA) managing your file, and the payment to the Conformity Assessment Body (CAB) that carries out the assessment. These are two different services, so they always appear as separate line items in a quote — never combined into one sum. The RAA fee covers document preparation, submission, and communication with the CAB and the Ministry of Health. The CAB payment covers the assessment itself: the audit, certificate issuance, or registry review.

Three routes, three different costs

Class I devices, and IVD products in the general/other category, go through self-declaration. Under this procedure you submit data to Derzhliksluzhba — this is the simplest and cheapest option, and the CAB is usually not involved. That said, when classification is unclear, we sometimes ask the CAB for written confirmation of the class — this costs extra, but lowers the risk of rejection.

Class IIa, IIb and III devices — as well as IVD List A, List B, and self-testing devices — are assessed by a Ukrainian CAB. If you hold a valid CE certificate from a recognized EU Notified Body, you can use the CE recognition route. In this case, the CAB uses the notified body’s audit results as the basis for its own Ukrainian report, instead of reviewing everything from scratch. But this isn’t a simplified, audit-free procedure: the CAB still requires the notified body’s audit reports for the full certification cycle, plus confirmation from the notified body of exactly which models the certificate covers. After registration, you’re also required to notify the CAB of any changes to the CE certificate — sometimes this is billed separately too.

If you don’t have a CE certificate, or it isn’t recognized, the CAB carries out a full Quality Management System audit against ISO 13485. Today this audit is done remotely. This isn’t a workaround — it’s a separate, fully valid route with its own document list. In other words, not having a CE mark doesn’t by itself block registration in Ukraine.

Costs that don’t show up on day one

A Ukrainian Authorized Representative is mandatory for every foreign manufacturer, regardless of class. The AR fee is structured as an annual payment, paid in full upfront, covering a full year of regulatory responsibility regardless of how fast the registration itself moves. Manufacturers who price out “the project” sometimes miss that this payment continues after the certificate is issued.

Ukrainian-language labelling and instructions for use are mandatory. Translation is billed separately from both the RAA fee and the CAB payment — the cost depends on document volume, so a product with a long IFU costs more to localize than one with a short IFU. Occasionally there are additional costs too: notarizing certain documents, or confirmation letters from the CAB. These don’t come up on every project, but it’s better to budget for the possibility than to be surprised by it.

Obligations after registration cost money too, even when nothing changes about the product. There’s a yearly technical surveillance system in place (under standard DSTU ISO/IEC 17021-1, clause 9.1.3.3) — once a year the CAB checks whether the manufacturer’s quality system still meets requirements. On top of that, you need to keep the technical file current and maintain complaint and vigilance records. None of this is included in the initial certification fee.

Changes after registration are billed separately too: a new item added to an existing line, a CE certificate reissued by the notified body, any administrative update. This is separate work, not part of the original scope.

Where the real savings are

The most expensive mistake is choosing a route without fully checking whether it fits. For example, counting on CE recognition when the certificate was issued by a notified body the Ukrainian CAB doesn’t recognize. Or filing for self-declaration on a product the CAB later reclassifies into a higher class. The second costly mistake is starting the process with an incomplete document package: gaps found during review cost more, through delay, than it would have cost to close them upfront.

A third, less obvious mistake is choosing an Authorized Representative tied to your distributor instead of an independent one. At first this looks convenient. But if the relationship with the distributor changes, you’ll need to change AR — a new procedure with new costs that could have been avoided by choosing an independent AR from the start. 

Want to see exactly which documents your device class needs, before you request a quote? Leave a request through the form at the bottom of the page and tell us your device class — we’ll send you the full document checklist, by class and by route (CE recognition or remote QMS audit). That way you know what to gather before the process even starts.