Russia Unveils New Clinical Trial Requirements for Medical Devices
Russia's Ministry of Health has issued an order establishing a requirement that medical organizations obtain approval before conducting clinical trials on medical devices and setting forth procedures for ensuring compliance.
According to the order, before undertaking a clinical trial, a medical organization must submit an application to Russia's Federal Service on Surveillance in Healthcare, Roszdravnadzor, together with a host of required documents.
Information to be submitted includes the entity's address and contact information; license for medical practice indicating the medical activities involved in the medical device testing to be conducted; the entity's charter; information on its intensive care unit, if the trial involves a high risk device; measures for ensuring protection of confidential information; information on bed space, structure, staffing; and history of regulatory compliance.