General information

Опубліковано 09.05.2022 о 07:16

Division for State Market Surveillance over the Circulation of Medical Devices provides such activities

Development of the market surveillance legislation and regulations.

Development of sectoral plans for state market surveillance, monitoring the implementation and revision of these plans.

Dealing with proposals, inquiries, complaints, applications, appeals, messages from consumers (consumer association), as well as executive authorities, law enforcement agencies, executive bodies of local councils, public consumer organizations (consumer associations) on matters within the competence of the Division.

Monitoring the causes and number of appeals of consumers (users) to protect their right to safety of medical devices, the causes and number of accidents and cases of harm to human health as a result of their consumption (use).

Ensuring the maintenance of the Register of persons responsible for the introduction of medical devices, active implantable medical devices and in vitro diagnostic medical devices, and the Journal of Consumer (User) appeals for protection of their right to medical devices safety. 

Ensuring storage of the State Register of medical equipment and medical devices.

Participation in inspections of the characteristics of medical devices, including the selection of their samples for their examination (testing).

Participation in the preparation and implementation of proposals on international cooperation, participation in relevant international and national conferences.

Maintenance of the national information system of the state market surveillance and the system of the mutual rapid alert  notification system.

Monitoring information from foreign reporting systems about medical devices that pose a serious risk.

Interaction with territorial authorities, state-owned enterprises  are in the management of the State Service on Medicines and Drugs Control,  on the implementation of state policy in the sphere of state market surveilliance.

Dealing with reports of territorial authorities of the State Service of Ukraine on Medicines and Drugs Control  on their implementation of state market surveillance and their summarizing.

Monitoring the actions of business entities on the withdrawal from circulation and/or recall of medical devices in respect of which a decision on withdrawal from circulation and/or recall has been made.

Monitoring the actions of business entities to withdraw from circulation and/or recall medical devices regarding which a decision was made to withdraw from circulation and/or recall. 

Timely warning of consumers (users) on the detected danger posed by medical devices.

Establishing cooperation with business entities to prevent or mitigate the risks that constitute medical devices provided by these businesses in the marketplace.

Ensuring the operation and improvement of certain processes of the quality management system of the State Service for Quality Management within the competence of the Division.

Generalization of the results of the implementation of state market supervision by the State Service of Ukraine on medicines and Drugs Control as well as its territorial authorities, the analysis of the causes of identified violations.

Development and submission of proposals to revise the requirements established in technical regulations, if they provide an adequate level of protection of the public interest, in accordance with the established procedure.

Review of documents in order to make a decision on the feasibility of clinical trials of medical devices in accordance with the requirements of technical regulations.

Informing the authorities, local authorities and the public about the results of market surveillance.

Informing state bodies, local authorities and the public about the results of market surveillance.

Preparation of materials for boards, meetings, seminars, meetings on issues within the competence of the Division.

Providing trainings and advanced training of market supervision officials.

Participate in the generalization of data and proposals for analysis and improvement of the management quality system of the State Service of Ukraine on medicines and Drugs Control.

Interacts with the authorized quality person  on the implementation of the requirements of the quality management system of the State Service of Ukraine on Medicines and Drugs Control.

Participates in the organization and conducting of personnel training on the requirements of quality management system of the State Service of Ukraine on medicines and Drugs Control, including the requirements of Ukrainian and EU legislation, and other regulatory documents on issues within the competence of the Division.

Providing methodological and advisory assistance to business entities and citizens on the tasks assigned to the Division.

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