医疗器械​澳大利亚TGA认证哪里可以做？

澳大利亚TGA全称是The Therapeutic GoodsAdministration，是澳大利亚政府卫生部的一部分，负责管理治疗用品，包括处方药、疫苗、防晒霜、维生素和矿物质、医疗设备、血液和血液制品。几乎任何声称具有治疗功效的产品都必须被登记在澳大利亚ARTG，才能在澳大利亚供应。

The Therapeutic Goods Administration (TGA) is part of theAustralian Government Department of Health, and is responsible forregulating therapeutic goods including prescription medicines,vaccines, sunscreens, vitamins and minerals, medical devices, bloodand blood products. Almost any product for which therapeutic claimsare made must be entered in the Australian Register of TherapeuticGoods (ARTG) before it can be supplied in Australia.

医械产品分类确定

The manufacturer is responsible for determining theclassification of a device using a set of classification rulesbased on the:

1.医疗器械的预期用途。

·manufacturer’s intended use of the device

2.对病人，用户及其他人的风险等级。

·level of risk to patients, users and other persons (theprobability of occurrence of harm and the severity of thatharm)

3.植入人体的程度。

·degree of invasiveness in the human body

4.使用时限。

·duration of use

 其分类等级划分如下表：

符合性评估

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 (the Act)

Therapeutic Goods (Medical Devices) Regulations 2002 (theRegulations)

符合性评估证据类型：

The TGA accepts the following certificates as conformityassessment 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 Assessment Certificate issued by the TGA - thisis mandatory for some manufacturers

-澳大利亚EC MRA 符合性证书

certificates of conformity issued under the Australia-EC    MRA

-澳大利亚 EFTA MRA 符合性证书

certificates of conformity issued under the Australia -EFTAMRA

-由欧盟公告机构颁发的EC证书

EC certificates issued by an EU Notified Body

 符合性评估所需材料：