什么是符合性评估？
制造商必须能够证明该器械以及制造该器械的过程符合澳大利亚相关法规的要求。
相关法规如下：
Therapeutic Goods Act 1989 (theAct)
Therapeutic Goods (Medical Devices)Regulations 2002 (the Regulations)
符合性评估证据类型：
The TGA accepts the followingcertificates as conformity assessment evidence:
-TGA颁发的符合性评估证书（对部分企业是唯一途径）
a TGA Conformity AssessmentCertificate issued by the TGA - this is mandatory for somemanufacturers
-澳大利亚EC MRA 符合性证书
certificates of conformity issuedunder the Australia -EC MRA
-澳大利亚 EFTA MRA 符合性证书
certificates of conformity issuedunder the Australia -EFTA MRA
-由欧盟公告机构颁发的EC证书
EC certificates issued by an EUNotified Body
Part
内容
适用类别
Part 1
①全面质量保证(Full assuranceprocedure)
①适用于全部类别
②设计检验(Examination of Design)
②适用于II,AIMD类
Part 2
型式检验(Type examination)
IIb, II, AIMD类
Part 3
验证过程(Verification procedures)
|类(测量) ,lla, lb,
I, AIMD类
Part 4
产质量保证(Production assurance)
I, lla, IIb, II, AIMD类
Part 5
产品质量管理体系(Product managmentsystem) l类(测量) , lla, IIb
类
Part 6
符合性声明(免Secretary评估)
l类,l类(测量和/或无
菌) , lla类
Part 7
特殊用途器械符合性评估程序(ConformityAssessment
全部
Procedures for devices used for aSpecial Purpose)
Part 8
临床评估程序(Clinical Evaluationprocedures)
