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Medical devices
— Market requirements for medical devices
— Establishment of marketing authorization
— Renewal of registration and changes
— Dossier structure (necessary documents)
— State registry of medical devices
— Sanitary epidemiological conclusion
— Certification of medical devices
— Ukrainian legislation
— Portfolio

Dossier structure (necessary documents)

Below you can find list of documents required for state marketing authorization (registration) of medical device in Ukraine. 

Please consider that list of documents is generalized and can be applied for most of products. Therefore some specific groups of products such as medical devices for in-vitro diagnostics, active implants, ophtalmic products etc. have slightly different requirements. Please contact us for detailed list of documents applied for your type of products. 

List of documents required for state registration (marketing authorization) of medical device in Ukraine: 

  1. Application form (form of document will be developed by us and sent for your approval). 
  2. List of all modifications, models, parts, disposables that will be shipped as a parts of medical device, with (and for) medical device or will be shipped to Ukraine later.
  3. Power of Attorney issued on the name of Cratia (form of the document will be sent by us). 
  4. Instructions for use, user’s manual, technical characteristics.
  5. Brochure (description of the device with a photo) or catalogue of devices.
  6. Certificate of origin of medical devices.
  7. Certificate of marketing authorization of medical devices in manufacturer’s country (or Exportation certificate or Free sales certificate).
  8. Certificates of marketing authorization from other countries (Russian Federation, other CIS countries).
  9. Certificate of state registration of manufacturer(s) legal entity (certificate of incorporation). 
  10. Manufacturing license, other applicable manufacturer’s certificates.
  11. CE certificate and Declaration of conformity to MDD Directive 93/42/ЕЕСor relevant Directive for IVD. Declaration of conformity should include safety class of medical devices. 
  12. Certificates ISO 9001; ISO 13485. Other available certificates on quality management system or established standards.
  13. Protocols of the preclinical and clinical studies, other studies and scientific information. Literature (articles) on medical use of the device. Recommendation letters from doctors regarding use of medical device. Any other evidences of safety and efficiency use of medical device in other countries.
  14. Certificates of analysis/quality (if applicable).
  15. If sterility is applied - certificate of sterility, description and validation of sterilization method.   
  16. Labeling information according to international standard EN 980.
  17. Certificate of state registration of Applicant’s legal entity (certificate of incorporation), if Applicant differs from manufacturer. 
  18. Document that explains relations between Applicant and manufacturer, if Applicant is different from manufacturer. It can be Power of Attorney, Letter of Authorization etc. 

Dossier structure (necessary documents) | Cratia

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Documents under points 3, 7, 9, 11, 12, 17 and 18 require proper legalization. 

If you have any quesitons - you can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting at our office.