Licensing or Management Quality Assessment?
Roszdravnadzor is not intending to license, but suggests correction of its authority in respect of licensing of medical products.
Head of Roszdravnadzor Mikhail Murashko told about that. He said that the administration he leads is planning to refuse licensing as such, but to assess the degree to which the institution depending on the class of risk and the type of medical product is using its knowledge and certificates within the framework of manufacture.
“We are planning, — says Murashko, — to switch to another procedure, abandoning the procedure of production licensing. The key approach to the new system of control will be not only “document expertise of materials”, but also “assessment of quality management system for production of medical devices”.