Russia In current regulation of standards is voluntary in premarket MD evaluation. And Regulator does not recognize any standard which Russian Ministry of could provide presumption of conformity. Health But when on the market, some types of MD have to be certified for Roszdravnadzor particular mandatory standards (list of mandatory standards and types of MD is available on Regulator’s web site). It should be noted, that this regulation is to be canceled on 01/01/2016. The United States of IEC 62304:2006 is recognized by the US FDA medical device America program as a consensus standard for which a person may submit a declaration of conformity in order to meet a premarket submission US Food and Drug requirement or other requirements to which a standard is applicable. Administration (US US FDA by recognizing IEC 62304:2006 is acknowledging that the FDA) process activities and tasks identified in this standard when used with a good quality management system and risk management system can help assure safe design and maintenance of software used in medical devices.
Russia Russian Ministry of Health Roszdravnadzor In current regulation of standards is voluntary in premarket MD evaluation. And Regulator does not recognize any standard which could provide presumption of conformity. But when on the market, some types of MD have to be certified for particular mandatory standards (list of mandatory standards and types of MD is available on Regulator’s web site). It should be noted, that this regulation is to be canceled on 01/01/2016. The United States of America US Food and Drug Administration (US FDA) IEC 62304:2006 is recognized by the US FDA medical device program as a consensus standard for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirements to which a standard is applicable. US FDA by recognizing IEC 62304:2006 is acknowledging that the process activities and tasks identified in this standard when used with a good quality management system and risk management system can help assure safe design and maintenance of software used in medical devices.