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.
Power of Attorney issued on the name of Cratia (form will be sent by e-mail). Document should be legalized.
Instruction for use, user’s manual, technical characteristics.
Brochure (description of the device with a photo) or catalogue of devices.
Certificate of origin issued on the headed paper of manufacturer.
Certificate of State registration of medical devices in manufacturer’s country (Exportation certificate or Free sales certificate). Document should be legalized.
Certificates of registration from other countries (Russian Federation, other CIS countries etc.).
Certificate of state registration of manufacturer(s) legal entity (usually that document is issued by Chamber of Commerce or by other state authority). Document should be legalized.
Manufacturing license, other applicable manufacturer’s certificates. Document should be legalized.
CE certificate (CE mark). Document should be legalized.
Certificate of compliance to Directive 93/42/ЕЕС or relevant Directive for IVD (Declaration of conformity with mentioned safety class referred to Directive 93/42/ЕЕС). Document should be legalized.
Certificates ISO 9001; ISO 13485. Other standard compliance certificates. Document should be legalized.
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.
Certificates of analysis/quality (if applicable).
If sterility is applied - certificate of sterility, description and validation of sterilization method.
Labeling information according to international standard EN 980.
Certificate of state registration of Applicant’s legal entity (usually that document is issued by Chamber of Commerce or by other state authority), if Applicant is different from manufacturer. Document should be legalized.
Document that explains relations between Applicant and manufacturer, if Applicant is different from manufacturer. It can be Power of Attorney, Letter of Authorization etc.
Documents must be provided in Russian, Ukrainian or English language. In case if original document is provided in other language – at least translation into English is obligatory.
All printing, translation and copying works will be done by Cratia.
If you are interested in services of certification of the medical devices – you can find following additional information at our website:
Marketing license and state registration of medical devices, health instruments, healthcare equipment in Ukraine. Regulatory affairs on medical devices, approval of marketing permission on medical device. Ukraine, Kiev, Cratia Ltd.
Marketing approval, regulatory affairs on medical devices, medical and healthcare goods in Ukraine. State registration of medical devices. Ukraine, Kiev, Cratia Ltd.
