Registration of medical products in Ukraine: procedure, documents, terms

The introduction and utilization of medical devices are permissible only following the completion of the product's conformity assessment procedure in accordance with the Technical Regulations and upon obtaining a Certificate of Conformity issued by the authorized Certification Body.

The conformity assessment procedure is categorized into several types, contingent upon the risk class of the medical device and its specific characteristics. 

The assessment procedure may be conducted through self-declaration, manufacturer audits, batch assessment procedures, or by acknowledging the results of work carried out by a European notified body. 

Simultaneously, the classification of a medical device (I, IIa, IIb, or III) is contingent upon the potential risk associated with its application. 

Criteria for classification encompass: 

• Duration of usage
• Invasiveness
• Contact with the human body and/or interaction with it
• Method of introducing the medical device into the human body (e.g., anatomical or surgical)
• Application for vital organs and systems of the human body
• Utilization of energy sources in conjunction with the medical device

The class and characteristics of the medical device also dictate the necessity for involving the Certification Body and conducting a manufacturer audit. The higher the class, the more significant the risk, and the more intricate the certification procedure.

The following documents are to be submitted for the conformity assessment procedure:

For medical devices falling under self-declaration:

1. Confirmation letter for self-declaration from the certification body
2. Technical file
3. Translations of manufacturer documentation into the Ukrainian language
4. Declaration of Conformity to Technical Regulations
5. Copy of the agreement from the manufacturer and power of attorney for the authorized representative

For undergoing conformity assessment with the involvement of a conformity assessment body:

1. Documents from the manufacturer for initial assessment (Quality Certificate, compliance certificate with regulatory requirements, etc.)
2. Declaration of conformity
3. Clinical assessment of the medical device
4. Manufacturer's application for conformity to the quality management system (for assessment)

Based on the Declaration of Conformity, Clinical Assessment, Auditor's Report, and after the manufacturer's audit by the Assessment Body, a Certificate of Conformity to local Technical Regulations is issued. After obtaining the certificate, these products can be introduced to the market.

The cost of assessment services depends on the class of the medical device, the quantity of medical devices to be assessed, the country of the manufacturer, and the number of locations to be audited. Additionally, it is contingent upon the availability of all necessary documents and tests from the manufacturer.

Audit duration: a minimum of 30 calendar days.

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Which authorities are empowered to conduct assessments?

Authorities accredited by the National Accreditation Agency of Ukraine, in compliance with specific international and domestic technical standards.

The document that typically presents the most challenges is the catalog of medical products. The difficulties often arise not only from the fact that it's challenging to locate but also because, even when found, there's a likelihood that it may not be suitable for the declaration procedure. Our legal experts, working on this aspect of the declaration process, usually assist in determining or modifying the catalog to ensure it allows for registration with the State Medical Service.

If you are uncertain about proceeding with the entire procedure, feel free to reach out to our legal experts for an initial consultation or the development of a Roadmap. We will analyze your situation and provide a step-by-step plan to achieve your goal. Whether to proceed independently or to order the complete certification of medical products is a decision for you to make.

Learn more about the registration of medical equipment or medical devices here.