MainStandardized proceduresObtainment of licenses and permits in UkraineRegistration of medical equipment or medical products in Ukraine

Registration of medical equipment or medical products in Ukraine

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COST AND TERM

The cost of medical equipment/medical product registration service is negotiable.

Additionally it is required to pay the official fee:

  • 850 UAH for registration of medical equipment;
  • 340 UAH for registration of a medical product.

Additionally Client must pay for an expertise the cost of which is set by an agreement with expertise center and an applicant.

Term of registration certificate obtainment is 3 month.

What we do
  • consult Clients;
  • prepare and submit documents that are required for registration of medical equipment and medical products to the State Inspectorate for Quality Control of Medicines ;
  • obtain certificate of state registration of medical equipment and medical products.

REQUIRED DOCUMENTS

To provide service of medical equipment or medical product registration Client provides the following documents:

  • manual (instruction) on  medical product use;
  • certificate of origin of a medical product;
  • certificate of medical product compliance  with the requirements of quality and safety;
  • notarized copies of regulatory documents, information about standards, regulatory framework that serves as a base of product manufacturing;
  • documents on determination of medical product safety class based on the potential risks of use and also materials of preclinical and clinical examination/testing;
  • catalogue of medical products;
  • conclusion certificate of state metrology certification (for measuring instruments);
  • label or labeling sample for a medical product;
  • notarized copy of state registration certificate or an extract from the Unified State Register of enterprises, organizations and institutions;
  • original of payment order about state duty payment with bank’s notation.

It is required to provide triplicate of all the listed documents (originals, notarized copies or copies attested by the authority that issued it) translated into Ukrainian.

Important to know

All medical products made in Ukraine or imported to Ukraine are subject to state registration in accordance with the List of the Ministry of Healthcare of Ukraine.

Certificate of medical product registration serves as a legal ground of its importing to Ukraine, its use and distribution.

The validity term of the registration is unlimited. For medical products made in Ukraine that have not passed qualification tests the validity term is 2 years.

If a medical product includes a medical drug the validity term cannot exceed the term of registration certificate for such drug.

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When term, cost and procedure of registration are agreed Client signs an agreement of legal services provision. Client delivers the listed documents personally or via courier. When all the required documents are prepared and signed by Client our lawyers file the documents to the State Service of Ukraine on Medical Drugs.

Within the agreed term our firm delivers medical product registration certificate (for Clients located in other regions via courier). After provision of accreditation certificate work completion certificate is signed.

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