On October 29, 2020, the State Medical Service of Ukraine as a body of state market supervision of medical devices published a draft sectoral plan of state market supervision for 2021, adding a justification to it.
Thus, during the development of the draft sectoral plan of DLS, the types of products are considered to be at increased risk, the results of monitoring the causes and number of cases of harm to human health due to consumption (use) of products, analysis of information obtained through international product notification systems. poses a serious risk, appeals from consumers (users), executive authorities, law enforcement agencies, and the results of the territorial bodies of the State Medical Service for state market surveillance in 2020, as well as the epidemiological situation with the spread of coronavirus disease (Covid-19 ).
The list of types of products that belong to the high degree of risk:
- medical devices – the purpose of products for a certain category of consumers (users) (in particular, children depending on age, pregnant women, the elderly, people with disabilities), which such products can be used, the use of chemical and biological substances, that may adversely affect human health or pose a serious risk;
- in vitro diagnostic medical devices – the purpose of products for a certain category of consumers (users) (in particular, children depending on age categories, pregnant women, the elderly, people with disabilities), which such products can be used.
This draft plan is currently being discussed.