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：
1.Therapeutic Goods Act 1989 （the Act）
2.Therapeutic Goods （Medical Devices） Regulations 2002 （the Regulations）
符合性评估证据类型：
The TGA accepts the following certificates as conformity assessment evidence：
1.TGA颁发的符合性评估证书（对部分企业是唯一途径）
a TGA Conformity Assessment Certificate issued by the TGA - this is mandatory for some manufacturers
2.澳大利亚EC MRA 符合性证书
certificates of conformity issued under the Australia -EC MRA
3.澳大利亚 EFTA MRA 符合性证书
certificates of conformity issued under the Australia -EFTA MRA
4.由欧盟公告机构颁发的EC证书
EC certificates issued by an EU Notified Body
