Medical Device Single Audit Program

GPTKB entity

Predicate	Object
gptkbp:instanceOf	regulatory program
gptkbp:abbreviation	gptkb:MDSAP
gptkbp:acceptsAuditReports	participating regulatory authorities
gptkbp:administeredBy	gptkb:IMDRF gptkb:International_Medical_Device_Regulators_Forum
gptkbp:appliesTo	medical device manufacturers
gptkbp:auditPerformedBy	authorized auditing organizations
gptkbp:auditStandard	gptkb:ISO_13485 country-specific requirements
gptkbp:benefit	facilitates international market access improves regulatory oversight reduces audit duplication
https://www.w3.org/2000/01/rdf-schema#label	Medical Device Single Audit Program
gptkbp:launched	2014
gptkbp:purpose	streamline medical device audits allow a single audit to satisfy multiple regulatory authorities
gptkbp:regulates	gptkb:Therapeutic_Goods_Administration gptkb:Pharmaceuticals_and_Medical_Devices_Agency gptkb:Health_Canada gptkb:U.S._Food_and_Drug_Administration gptkb:Brazilian_Health_Regulatory_Agency
gptkbp:scope	quality management system audits
gptkbp:status	voluntary
gptkbp:statusInAustralia	voluntary
gptkbp:statusInBrazil	voluntary
gptkbp:statusInCanada	mandatory for Class II, III, IV medical devices
gptkbp:statusInJapan	voluntary
gptkbp:troopContributingCountries	gptkb:Australia gptkb:Brazil gptkb:Canada gptkb:Japan gptkb:United_States
gptkbp:website	https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap
gptkbp:bfsParent	gptkb:MDSAP
gptkbp:bfsLayer	7