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澳大利亚TGA降低医疗器械年度费用
日期:2020年09月25日

由于COVID-19的原因,澳大利亚暂停了选择性手术,这对部分医疗器械行业产生了重大影响,为此,政府已同意将某些医疗器械的年费降低50%。2020-21财政年度规定减少50%年度费用的医疗器械包括:在澳大利亚治疗用品注册簿(ARTG)中列为IIa、IIb、III和AIMD类并且在2020年4月8日生效的《私人健康保险(假肢)规则(第1号)》的定义中列为假肢的医疗器械。


这些费用列在2018治疗用品(费用)条例中。

有资格的赞助商无需采取任何行动,因为澳大利亚治疗用品管理局(TGA)将使用2020年4月8日生效的《假肢清单》(PL),并参照ARTG纳入编号来识别那些将接受减费的医疗设备。

减少年费的规定也适用于那些ARTG条目中包含多个产品,而PL中只列出条目所涵盖的部分产品的医疗设备。

赞助商将在8月收到2020-21年的年费发票,其中将自动包含此类设备的减价费用。



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.


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.


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