RAA (Regulatory Affairs Agency) is an independent agency for medical device registration in Ukraine. We help foreign and Ukrainian manufacturers bring their products to the market: from classification and the technical file to the entry in the State Service register. We also act as the manufacturer’s Authorized Representative in Ukraine. Our clients include manufacturers from Europe, Asia and the USA.
Who is behind RAA
Serhii Kharchenko
Founder of RAA, Regulatory Affairs & Quality Specialist
I have worked in regulatory affairs and certification of medical products since 2001. I lead every RAA project personally.
- Roche Ukraine, Diagnostics2017–2023 · registration of IVDs, medical devices and software as IVD, SOPs, Veeva Vault RIMS, EMEA/APAC regulatory support
- Regulatory Affairs Specialist for EU manufacturers2014–2017 · CE marking of Class I–III devices, technical documentation, clinical evaluation, Notified Body submissions
- B. Braun, Carl Zeiss, Ontex2001–2014 · product registration and certification, customs clearance, procurement
Certificates: BSI (UK) — ISO 13485, Design Dossier; BioPharma Institute (USA) — GMP documentation. Working languages: English, Ukrainian.
Why an independent Authorized Representative
You don’t depend on one distributor
You can work with several partners in Ukraine and change them without stopping supplies.
Registration stays under your control
The documents and the register entry stay with the manufacturer, not with the distributor.
No conflict of interest
We don’t sell your products and don’t compete with your partners.
One contact for everything
We deal with the State Service, Conformity Assessment Bodies and your distributors.
How we work
- RequestYou send a description of the device and the documents you already have.
- AnalysisWe define the risk class, the procedure and the list of documents, and give you the cost and timeline.
- DocumentsWe prepare the technical file, the Declaration of Conformity and the translation of labelling and IFU.
- SubmissionWe submit the documents to the Conformity Assessment Body or the State Service and handle all correspondence.
- After registrationWe remain your Authorized Representative and help with any changes.
Our services
Authorized Representative →
We represent foreign manufacturers in Ukraine
Medical device registration →
Self-declaration, CE recognition, full conformity assessment
CE marking MDR / IVDR →
EU market entry strategy, technical documentation
Practical cases →
How we solved our clients’ problems
Tell us about your device — we will tell you where to start.