【原】【麥祥時訊】澳大利亞TGA降低醫(yī)療器械年度費用

麥祥醫(yī)藥科技 2023-07-06 發(fā)布于江蘇

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由于COVID-19的原因,，澳大利亞暫停了選擇性手術,，這對部分醫(yī)療器械行業(yè)產(chǎn)生了重大影響,，為此，政府已同意將某些醫(yī)療器械的年費降低50%,。2020-21財政年度規(guī)定減少50%年度費用的醫(yī)療器械包括：在澳大利亞治療用品注冊簿（ARTG）中列為IIa,、IIb、III和AIMD類并且在2020年4月8日生效的《私人健康保險（假肢）規(guī)則（第1號）》的定義中列為假肢的醫(yī)療器械,。

2020-21假肢清單中的醫(yī)療器械年度費用
Class of medical device	Charge	Regulation
AIMD	$600	Item 7(4A)(b)
Class III	$600	Item 7(4A)(b)
Class IIa	$470	Item 7(4A)(a)
Class IIb	$470	Item 7(4A)(a)

這些費用列在2018治療用品（費用）條例中,。

有資格的贊助商無需采取任何行動，因為澳大利亞治療用品管理局(TGA)將使用2020年4月8日生效的《假肢清單》(PL),，并參照ARTG納入編號來識別那些將接受減費的醫(yī)療設備,。

減少年費的規(guī)定也適用于那些ARTG條目中包含多個產(chǎn)品，而PL中只列出條目所涵蓋的部分產(chǎn)品的醫(yī)療設備,。

贊助商將在8月收到2020-21年的年費發(fā)票,，其中將自動包含此類設備的減價費用。

In response to the suspension of elective surgery due to COVID-19 and thesignificant impact this has had on parts of the medical devices industry, theGovernment has agreed to provide a 50 per cent reduction in annual charges forcertain medical devices. The 50 per cent reduction in annual charges will beprescribed for the 2020-21 financial year for medical devices included in theAustralian Register of Therapeutic Goods (ARTG) as Class IIa, IIb, III and AIMDand which are listed prostheses as defined in the Private Health Insurance (Prostheses) Rules (No.1)2020, as in force on 8 April 2020.

Annual charges for medical devices listed on Prostheses List for 2020-21
Class of medical device	Charge	Regulation
AIMD	$600	Item 7(4A)(b)
Class III	$600	Item 7(4A)(b)
Class IIa	$470	Item 7(4A)(a)
Class IIb	$470	Item 7(4A)(a)

No action is required by eligible sponsors as the Therapeutic GoodsAdministration (TGA) will use the published Prostheses List (PL) as in force on8 April 2020 with reference to the ARTG inclusion number to identify thosedevices which will be subject to the reduced charges.These charges are in the Therapeutic Goods (Charges) Regulations 2018

The reduced annual charge would also apply to an ARTG entry where multipleproducts are included in the entry and only some products covered by the entryare listed on the PL.

Sponsors will receive an invoice in August for the 2020-21 annual charges,which will automatically include the reduced charges for such devices.