澳大利亞TGA注冊

澳大利亞TGA認證

澳大利亞TGA全稱是The Therapeutic Goods Administration，是澳大利亞政府衛生部的一部分，負責管理治療用品，包括處方藥、疫苗、防曬霜、維生素和礦物質、醫療設備、血液和血液制品。幾乎任何聲稱具有治療功效的產品都必須被登記在澳大利亞ARTG，然后才能在澳大利亞供應。

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

醫械產品分類確定

The manufacturer is responsible for determining the classification of a device using a set of classification rules based on the:

1.醫療器械的預期用途。

·manufacturer’s intended use of the device

2.對病人，用戶及其他人的風險等級。

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

3.植入人體的程度。

·degree of invasiveness in the human body

4.使用時限。

·duration of use

 其分類等級劃分如下表：

符合性評估

什么是符合性評估？

制造商必須能夠證明該器械以及制造該器械的過程符合澳大利亞相關法規的要求。

相關法規如下：

?Therapeutic Goods Act 1989 (the Act)

?Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)

符合性評估證據類型：

The TGA accepts the following certificates as conformity assessment evidence:

-TGA頒發的符合性評估證書（對部分企業是唯一途徑）

a TGA Conformity Assessment Certificate issued by the TGA - this is mandatory for some manufacturers

-澳大利亞EC MRA 符合性證書

certificates of conformity issued under the Australia -EC    MRA

-澳大利亞 EFTA MRA 符合性證書

certificates of conformity issued under the Australia -EFTA MRA

-由歐盟公告機構頒發的EC證書

EC certificates issued by an EU Notified Body

 符合性評估所需材料：

選擇微珂的理由：

       微珂醫藥擁有海內外專業成熟的技術團隊、以及與機構深度的戰略合作，服務于醫療器械企業，為企業提供優質的定制化服務，協助企業從產品技術要求編寫、產品檢測、臨床評價資料編寫與審核、申報與跟蹤，根據企業實際情況，進行質量管理體系建立，幫忙企業從管理到產品各環節一站式服務！