First online factory audit under EAEU regulation
For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad.
The FGBU VNIIIMT of Roszdravnadzor with the participation of Roszdravnadzor specialists began for the first time the remote inspection of medical device manufacturing located abroad (the manufacturing site, Tianjin Huahong Technology Co., Ltd, is located in the People’s Republic of China, the medical device is sterile disposable lancets).
During the inspection, Roszdravnadzor experts will hold working meetings via videoconference with the management of the Chinese company. They will also be able to view the company’s manufacturing sites and warehouses using live video.
Based on the results of all the activities carried out, Roszdravnadzor will make a decision on the medical device registration.
The manufacturing inspection format using remote interaction tools is in demand in order to allow medical devices to be put into circulation on the territory of the Eurasian Economic Union with the emerging threat of the spread of epidemic diseases or other force majeure circumstances, when the inspector cannot physically be present at the manufacturing site.
Reference: Inspection is carried out during the medical device’s registration within the Eurasian Economic Union for compliance with the Requirements for the implementation, maintenance and evaluation of a quality management system for medical devices, depending on the potential risk of their use, approved by Decision No. 106 of the Council of the Eurasian Economic Commission dated 10 November 2017.