文档介绍：Regulations
RegulationsfortheSupervisionandAdministrationofMedicalDevicesRegulationsfortheSupervisionandAdministrationocesarethosewhichareimplantedintothehumanbody，orusedforlifesupportorsustenance，orposepotentialrisktothehumanbodyandthusmustbestrictlycontrolledinrespecttosafetyandeffectiveness。
Theclassificationcatalogueformedicaldevicesshallbestipulated，adjustedandpromulgatedbythedrugregulatoryauthorityundertheStateCouncil,inaccordancewithclassificationprinciplesafterconsultingwithhealthauthorityundertheStateCouncil。
Article6Medicaldevicesproducedandusedforthepurposeofprovidingconcretemeasuringvaluesshallcomplywiththerequirementsofthemeteringlaw。ThedetailedproductlistshallbeformulatedandpromulgatedbythedrugregulatoryauthorityundertheStateCouncil,jointlywiththemeteringauthority。
ChapterIITheAdministrationofMedicalDevicesArticle7TheStateencouragestheresearchanddevelopmentofnewmedicaldevices.”Newmedicaldevices"refertothekindofbrandnewproductvarietieswhichhavenotbeenavailableinthedomesticmarket,orforwhichthesafety，effectivenessandproductmechanismhavenotbeenrecognizeddomestically。
TheclinicaltrialsofnewmedicaldevicesofClassIIandClassIIIcanbeconductedonlyafterclinicaltrialapprovalbytherelevantauthorityinaccordancewiththerulesofthedrugregulatoryauthorityunderStateCouncil.
Newmedicaldevicesthathavecompletedclinicaltrialsandpassedexpertsevaluationandrevieworganizedbythedrugregula