Japan All medical devices are required to satisfy the EPs that align with those defined in GHTF/SG1/N68:2012 Essential Principles of Ministry of Health, ISO 10993-1:2009 can Safety and Performance of Medical Devices. Labour and Welfare be used for its purpose, which is clearly referred to in checklist of (MHLW) EPs or certification/approval standards for each medical device. Pharmaceuticals and Medical Devices Agency (PMDA) Russia In current regulation using of standards is voluntary in premarket MD evaluation. And Regulator does not recognize any standard Russian Ministry of which 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 ISO 10993:2009 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 ISO 10993:2009 and ISO 10993-1:2013 FDA) believes these standards can successfully serve to address many of the issues associated with the biocompatibility evaluation of medical device. The standard is used by CDRH to identify the types of issues relevant to a biocompatibility risk assessment, and to determine if the currently available information (e.g., formulation, manufacturing, previously collected data, literature information) is sufficient, or if additional testing might be needed (per other parts of the 10993 standard).
Japan Ministry of Health, Labour and Welfare (MHLW) Pharmaceuticals and Medical Devices Agency (PMDA) All medical devices are required to satisfy the EPs that align with those defined in GHTF/SG1/N68:2012 Essential Principles of Safety and Performance of Medical Devices. ISO 10993-1:2009 can be used for its purpose, which is clearly referred to in checklist of EPs or certification/approval standards for each medical device. Russia Russian Ministry of Health Roszdravnadzor In current regulation using 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) ISO 10993:2009 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 ISO 10993:2009 and ISO 10993-1:2013 believes these standards can successfully serve to address many of the issues associated with the biocompatibility evaluation of medical device. The standard is used by CDRH to identify the types of issues relevant to a biocompatibility risk assessment, and to determine if the currently available information (e.g., formulation, manufacturing, previously collected data, literature information) is sufficient, or if additional testing might be needed (per other parts of the 10993 standard).
imdrf-proc-151002-biological-evaluation-n37.docx