Choose one correct answer 1. Monitoring of the safety of medical devices in the Russian Federation is carried out 1) The Ministry of Health of Russia 3) By Rospotrebnadzor 2) Roszdravnadzor 2. Registration of a message about an adverse event (incident) that occurred during the application medical devices, carried out by a government agency 1) on the day of receipt of the message 3) during 5 working days 2) within 3 business days 4) within 20 working days 3. The need to appoint an official responsible for monitoring the safety of medical devices in pharmacy organizations is estab- lished 1) Federal Law No. 323-FZ of 11/21/2011 2) By Order of the Ministry of Health of the Russian Federation dated 09/15/2020 No.980n 3) By Order of the Ministry of Health of the Russian Federation dated 19. 10. 2020 No. 1113n 4. The manufacturer (or his authorized representative) must submit to the state the body responsible for monitoring the safety of medical devices, a motivated position on the facts stated in the adverse event report during the 1) 1 day from the date of receipt of the notification from the state body 2) 3 days from the date of receipt of the notification from the state body 3) 5 days from the date of receipt of the notification from the state body 4) 10 days from the date of receipt of the notification from the state body 5. A report on an adverse event (incident) related to the use of the product, containing the final informa- medical tion about it, is 1) primary 3) final 2) subsequent 6. A report on an adverse event (incident) related to the use of a medical device containing information about this event (incident) that occurred for the first time is 1) primary 3)final 2) subsequent

Question

Choose one correct answer 1. Monitoring of the safety of medical devices in the Russian Federation is carried out 1) The Ministry of Health of Russia 3) By Rospotrebnadzor 2) Roszdravnadzor 2. Registration of a message about an adverse event (incident) that occurred during the application medical devices, carried out by a government agency 1) on the day of receipt of the message 3) during 5 working days 2) within 3 business days 4) within 20 working days 3. The need to appoint an official responsible for monitoring the safety of medical devices in pharmacy organizations is estab- lished 1) Federal Law No. 323-FZ of 11/21/2011 2) By Order of the Ministry of Health of the Russian Federation dated 09/15/2020 No.980n 3) By Order of the Ministry of Health of the Russian Federation dated 19. 10. 2020 No. 1113n 4. The manufacturer (or his authorized representative) must submit to the state the body responsible for monitoring the safety of medical devices, a motivated position on the facts stated in the adverse event report during the 1) 1 day from the date of receipt of the notification from the state body 2) 3 days from the date of receipt of the notification from the state body 3) 5 days from the date of receipt of the notification from the state body 4) 10 days from the date of receipt of the notification from the state body 5. A report on an adverse event (incident) related to the use of the product, containing the final informa- medical tion about it, is 1) primary 3) final 2) subsequent 6. A report on an adverse event (incident) related to the use of a medical device containing information about this event (incident) that occurred for the first time is 1) primary 3)final 2) subsequent

Answer 1

1. Monitoring of the safety of medical devices in the Russian Federation is carried out by Roszdravnadzor (2).2. Registration of a message about an adverse event (incident) that occurred during the application of medical devices, carried out by a government agency, is done within 3 business days (2).3. The need to appoint an official responsible for monitoring the safety of medical devices in pharmacy organizations is established by Order of the Ministry of Health of the Russian Federation dated 19.10.2020 No. 1113n (3).4. The manufacturer (or his authorized representative) must submit to the state body responsible for monitoring the safety of medical devices a motivated position on the facts stated in the adverse event report within 5 days from the date of receipt of the notification from the state body (3).5. A report on an adverse event (incident) related to the use of the product, containing the final information about it, is final (3).6. A report on an adverse event (incident) related to the use of a medical device containing information about this event (incident) that occurred for the first time is primary (1).

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