Russian manufacturer CEO received criminal term
The CEO of the chart paper factory in Belgorod received a criminal term for the manufacture and distribution of an unregistered medical device.
Thanks to the united actions of Roszdravnadzor and law-enforcement agencies in the territory of the Russian Federation, the manufacture and distribution of the unregistered thermal paper for medical video printers were discontinued. All products have been withdrawn from circulation.
Moscow’s Golovinsky District Court delivered a judgement against the CEO of ZAO “Chart Paper Factory” (Belgorod), which found him guilty of committing a crime as stipulated in Part 1 of Article 238.1 of the Criminal Code of the Russian Federation: on the manufacture and sale of an unregistered medical device: thermal paper for medical video printers.
The court found that the CEO of ZAO “Chart Paper Factory” had illegally manufactured unregistered medical devices (equivalent to the paper for ultrasound examination) using the equipment of the enterprise which he illegally supplied to the State Funded Health Care Facility of Moscow “Municipal Polyclinic No. 45 of the Moscow Health Department”.
Roszdravnadzor became involved in operational activity through the suspicions of law-enforcement agencies regarding the legality of the products supplied to the medical institution.
After an expert examination of the thermal paper, the specialists of the Federal State Budgetary Institution “All-Russian Research and Testing Institute of Medical Technology” of Roszdravnadzor concluded that “the roll thermal paper manufactured by ZAO “Chart Paper Factory”(Belgorod) for a medical video printer is not the chart paper and has been recognised by its properties and range of application to be an unregistered medical device, as not being compliant with the registration certificate issue no. FSR 2009/06045 and TU 9398-004-22261422-2009 for chart tapes”.
Based on the relevant expert report Roszdravnadzor published and posted an information notice “On an Unregistered Medical Device” on its official website with the requirement to have it withdrawn from circulation (No. 01И-1547/16 dated 11/08/2016).
In accordance with the judgement of Moscow’s Golovinsky District Court and the appellate resolution of the Moscow City Court, the CEO of ZAO “Chart Paper Factory” was sentenced to imprisonment for up to 3 years.
In accordance with Article 73 of the Criminal Code of the Russian Federation, the imprisonment was suspended with a probation period of six months.
Moreover, the money will be collected from the culpable entity in favor of the Moscow State Budgetary Healthcare Institution “Municipal Polyclinic No. 45 of the Moscow Health Department” for repayment of the financial losses incurred.
All unregistered products have been withdrawn from circulation on the territory of the Russian Federation.
In Russian – http://www.roszdravnadzor.ru/news/11757