 State registration of medical device is an obligatory requirement for import, sale and marketing of device in Ukraine. State registration is performed centralized in Department of regulatory policy of medicinal products and goods of healthcare area of Ministry of Health of Ukraine that is located in Kiev.
Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate of medical device is issued for 5 years and can be renewed before expiry.
First registration of the device must be performed professionally and very seriously, since:
- For some groups of medical devices correct registration can free from taxation (VAT tax) or reduce custom duties; incorrect registration can make device less competitive.
- After first import of the device all the information will be included to the customs internal database, future changes of custom commodity code will be almost impossible.
- Incorrect listing of modification can lead to impossibility of import of some or even all modifications of medical device.
- Not professional preliminary expertise of the documents and incorrect presentation of the dossier can lead to withdrawal (cancelling) of registration.
- Mistakes in names of the devices and/or manufacturing sites, incorrect labeling and other mistakes can lead to deny of import of medical device
We offer you full and overwhelming assistance of professional team that performs registration of more than 120 medical devices per year. We do know all aspects of state registration, we can advice the best solution for your group, we will avoid all treats and risks, we will perform the registration in shortest terms.
Procedure of cooperation between Cratia and new Customer can be presented in brief as following scheme:
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You send us first inquiry. Please specify the exact list of medical devices that you intend to register. Brochure, instruction of user’s manual, photo and composition will be very useful to determine and classify the device. |
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We carefully check the information, make our suggestions regarding custom commodity code, VAT taxation, safety class of the device and announce approximate price. We send you list of required documents, necessary forms and our comments regarding presentation and legalization of documents. |
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If the price is acceptable from your side, we sign the Confidentiality Agreement. You prepare the documents, we provide you with answers on all your questions and inquires. |
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If the price accepts, we sign the Confidentiality Agreement. You prepare the documents, we provide you with answers on all your questions and inquires. You send us the dossier. |
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We make the preliminary expertise, arrange translations, prepare and adopt with you Application and Annex (listing), package labeling and instruction for use (user’s manual), combine the dossier in accordance with local requirements and submit it to State Authority. |
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If required – we will apply for import of the samples of the device, assist you in prepare of custom documents, receive samples on our name and perform the custom clearance. We are authorized by custom offices as importer. |
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Upon the Power of Attorney issued on our name we represent your interests and manage the entire registration procedure: preliminary expertise, technical expertise, specific studies (sterility, metrological etc.), safety (toxicological) studies, medicinal (efficiency) studies. |
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After positive conclusion from all expertise and studies the product is included to the session of the State Authority. Adoption on the session means that product is registered in Ukraine. Original registration certificate and Annex will be transferred to you by World Courier. |
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Prices:
Average amount of service fee and budget for state fees are usually determined within one-two days after we receive preliminary information regarding device and list of modifications that should be registered. To make our reply more precise please send us:
- brochure, instruction of user’s manual, photo and/or composition;
- your suggestions regarding custom commodity code;
- information regarding location of manufacturing site(s), if not mentioned elsewhere;
- information regarding amount of modifications;
- information regarding registration in other CIS countries, copies of registration certificates if available;
Every inquiry is very valuable for us and we will definitely reply on your e-mail / fax / call.
Total budget for registration will consist from:
____1. Expenses for translation, localization, printing & copying the dossier: app. 400 – 1000 EURO (depends on language of the dossier, amount of materials etc.);
____2. State fees that include:
______a) issue of the decision on custom code by Chamber of commerce;
______b) payment for technical expertise;
______c) payment for specific expertise if necessary (sterility, metrology etc.);
______d) payment for safety (toxicological) expertise;
______e) payment for medicinal (efficiency) expertise;
______f) payment of state fee to Treasury of Ukraine;
______Budget for state fees can vary from 2000 to 7000 EURO (depends on class & type of ______device, necessity of specific studies, amount of modifications, structure of the dossier etc.);
____3. Cratia fee varies from 500 to 1200 EURO (depends on class & type of device, presence of all necessary documents, terms of registration etc.);
We are open and independent company that works officially. Our rights and obligations to represent your interests are determined by Power of Attorney; all terms, fees, timelines and all other information will be settled in Agreement.
We accept only bank payments in UAH, USD or EURO. We provide all necessary finance bookkeeping documents (Contract, Order, Invoice, Acts etc.).
Timing
Time to achieve new registration of medical device depends is app. 6-7 weeks from submission of the dossier. Timing and penalties will be included to the Contract.
If you are interested in services of our company in the field of state registration of the medical devices – you can find the following additional information at our website:
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