Return of medical device inspections by market surveillance authorities in Ukraine: what should market operators prepare for?

For more than four years, there were no market surveillance inspections concerning medical devices in Ukraine. Due to the COVID-19 pandemic, a ban on planned state market surveillance measures had been in place since March 2020, and in March 2022, a moratorium was introduced under Cabinet of Ministers Resolution No. 303 “On Suspension of State Supervision (Control) and State Market Surveillance Measures during Martial Law.” The absence of inspections allowed businesses to adapt more quickly to challenges and supply the market, but on the other hand, it created risks of non-compliant and unsafe products entering circulation. On September 14, 2024, Cabinet of Ministers Resolution No. 1052 came into force, removing the moratorium on both scheduled and unscheduled inspections of medical devices. In this article, we remind you of the key aspects of state market surveillance concerning medical devices, the duties, and responsibilities of market operators – manufacturers, authorized representatives, importers, and distributors.

The legal and organizational framework for the functioning of the state market surveillance system is established by the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products” (hereinafter referred to as the Law), and the market surveillance authority for medical devices is the State Service of Ukraine on Medicines and Drugs Control (State Service on Medicines).

According to the Law, inspections can be either scheduled, according to sectoral plans, or unscheduled. The inspection sites include manufacturers, distributors, importers, warehouses, and customs warehouses, as well as sales points, places of commissioning, fairs, exhibitions, and so on.

At the same time, the State Service on Medicines also conducts inspections of compliance with licensing requirements for pharmacies, manufacturing, importing, and selling medicines and may be involved in inspections of healthcare institutions.

A specific feature of unscheduled inspections for those who have introduced medical devices into circulation is that businesses are notified of the inspection 10 working days before it starts. However, this period is shorter for inspections related to licensing conditions for business activities, where the licensee is notified of an unscheduled inspection on the day of the inspection, in accordance with the Law of Ukraine “On Licensing of Certain Types of Economic Activities.”

During inspections of healthcare institutions, pharmacies, and other operational sites, the State Service on Medicines has access to storage locations, sales points, and places of medical device commissioning and may check the labeling and accompanying documentation. Labeling non-compliance is the main reason for the inspection of a medical device. Other reasons include errors or inaccuracies in the declaration of conformity and accompanying documents, as well as complaints from consumers or other market operators.

According to the Law, market operators must retain for 10 years and provide, upon request by the state market surveillance authority, information regarding from whom the products were received and to whom they were supplied. Therefore, the inspection of licensing conditions can lead to an inspection of the entity that introduced the medical devices into circulation, whether it be the national manufacturer, authorized representative, or importer.

Every medical device market operator has certain responsibilities set by the Law, Technical Regulations on medical devices, approved by Cabinet of Ministers Resolutions No. 753, 754, and 755 (hereinafter – the Regulations), and other legislative acts.

Distributors are required to check for the presence of mandatory labeling elements and, as mentioned earlier, to retain information about the supplier for 10 years. If a distributor is unable to provide information on where the medical device was obtained, the distributor is considered to be the entity that placed the product on the market, which significantly increases their obligations and liabilities.

Entities that have placed medical devices on the market (national manufacturers, authorized representatives of foreign manufacturers, and importers) are required to place on the market only products that comply with the Regulations and other applicable legislation, to retain documentation for at least 5 years (15 years for active implantable devices) from the time the last device was placed on the market, and to provide it upon request by the state market surveillance authority. Such documentation includes:

• The declaration of conformity and certificates, along with information regarding any amendments;
• Labeling and accompanying documentation, including the user instructions;
• General product descriptions and technical documentation required by the technical regulations for medical devices;
• Documents related to the quality management system;
• Conclusions of expert evaluations and test reports for samples;
• Documents that allow for the tracking of the product’s origin and its subsequent distribution (shipping documentation or contracts);
• Documentation that confirms compliance with other applicable technical regulations (e.g., the Radio Equipment Regulation, the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation, etc.).

It is important that the technical documentation be up-to-date and accurate. Documentation may be provided to the state market surveillance authority in its original language, but upon request, it must be translated at the operator’s expense into the official state language within no more than 30 working days.

Both distributors and entities that have placed medical devices on the market are obligated to cooperate with state market surveillance authorities on measures to mitigate risks posed by the products they supply or have supplied.

Based on the results of an inspection, the State Service on Medicines may decide to:

• Confirm the product’s compliance and allow its continued circulation;
• Prohibit the sale of the product until identified violations are rectified;
• Remove the product from the market.

In case of violations, fines may be imposed on the economic entity. The amount of the fines depends on the nature and severity of the identified violations:

• For placing on the market a product that poses a serious risk, a fine of six thousand non-taxable minimum incomes of citizens (102,000 UAH) may be imposed, and for a repeated violation of the same nature within one to three years, for which the entity has already been fined, a fine of twenty thousand non-taxable minimum incomes of citizens (340,000 UAH) will be imposed;
• For placing on the market a product that does not comply with established requirements, a fine of three thousand non-taxable minimum incomes of citizens (51,000 UAH) may be imposed, and for a repeated violation of the same nature within one to three years, for which the entity has already been fined, a fine of six thousand non-taxable minimum incomes of citizens (102,000 UAH) will be imposed;
• For creating obstacles by preventing the inspection of product characteristics and failing to comply with the legal requirements of officials conducting market surveillance, a fine of ten thousand non-taxable minimum incomes of citizens (170,000 UAH) will be imposed.

Given the more than four-year absence of market surveillance inspections, we recommend that market operators update their knowledge of rights, obligations, and liabilities, as well as review their products and documentation for compliance with legislative requirements.

Anna Hnatyuk, specialist in medical device conformity assessment
and head of the Authorized Representative sector at “Cratia” 
Maksym Bahriiev, managing partner at “Cratia”