TGA认证注册咨询|当确定优先申请人时相应的符合性评估或加入ARTG的申请将优先考虑

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The purpose of this guidance is to help manufacturers and sponsors understand legislative requirements and TGA processes, and provide guidance on how to comply with these requirements.

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This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative requirements and regulatory processes in Australia. It is the responsibility of each manufacturer or sponsor to understand and comply with legislative requirements. If necessary, manufacturers and sponsors should seek professional advice.

This document may be updated over time as required. Feedback on the guidance is always welcome.

About these guidelines

The purpose of these guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination or a medical devices (priority applicant) determination. These guidelines generally refer to such determinations, in either case, as ‘priority applicant determinations’.

For a medical device, including an in vitro diagnostic medical device (IVD), priority applicant determinations provide for a person to be a priority applicant in relation to either:

•an application for a conformity assessment certificate issued by the TGA or

•an application for inclusion in the Australian Register of Therapeutic Goods (ARTG).

When a priority applicant determination is made, the corresponding application for conformity assessment or ARTG inclusion will undergo priority consideration. This means that application will be allocated ‘front-of-queue’ priority throughout the relevant assessment processes by the TGA.

Obtaining a priority applicant determination does not, of itself, guarantee approval of the application for conformity assessment or inclusion. These applications must still be assessed against, and satisfy, the relevant legislative requirements, in order for conformity assessment certification to be issued, and/or for a kind of device to be included in the ARTG.

For more information about applications for TGA conformity assessment or for ARTG inclusion refer to Standards, guidelines & publications (medical devices & IVDs).

Priority applicant determinations cease to be in force after 6 months if no application for TGA conformity assessment or ARTG inclusion (as relevant) is made.

The two types of priority applicant determinations

If you seek priority consideration in relation to a medical device, you only need to apply for one type of priority applicant determination.

Conformity assessment (priority applicant) determination

If you need a TGA-issued conformity assessment certificate, then the relevant priority applicant determination to apply for is a conformity assessment (priority applicant) determination.

If you obtain TGA conformity assessment, the process for inclusion in the ARTG does not require audit and typically occurs within a short period of time after the application for inclusion is lodged and the relevant application fee is paid. A separate application for a medical devices (priority applicant) determination seeking priority consideration in the inclusion process is not necessary.

Medical devices (priority applicant) determination

If you do not need a TGA-issued conformity assessment certificate (for example, you may already have overseas conformity assessment), and you seek priority consideration in the inclusion process, then the relevant priority application determination to apply for is a medical devices (priority applicant) determination.

If you do not require ‘front-of-queue’ priority consideration (for your conformity assessment application or inclusion application), you do not need to apply for a priority applicant determination.

Legislative framework

The relevant legislation regulating medical devices is:

•Therapeutic Goods Act 1989 (the Act) particularly Chapter 4 of the Act

•Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

The legislative framework for conformity assessment (priority applicant) determinations and medical device (priority applicant) determinations involves separate, but equivalent, provisions.

The Act contains framework provisions including that if a priority applicant determination is in force, it may be published on the Department’s website (sections 41ECA and 41FKA, respectively).

本指南的目的是帮助制造商和赞助人理解立法要求和TGA流程，并就如何遵守这些要求提供指导。

本指南仅供参考，鼓励制造商和赞助商熟悉澳大利亚的法律要求和监管流程。每个制造商或赞助商有责任理解并遵守法律要求。如有必要，制造商和赞助商应寻求专业建议。

本文件可根据需要随时更新。欢迎对指导意见进行反馈。

关于这些准则

本指南旨在帮助申请人寻求合格评定（优先申请人）决定或医疗器械（优先申请人）决定。这些指南通常将此类决定称为“优先申请人决定”。

对于包括体外诊断医疗器械（IVD）在内的医疗器械，优先申请人决定规定，在下列情况下，个人应为优先申请人：

•TGA签发的合格评定证书申请，或

•申请列入澳大利亚治疗品登记册（ARTG）。

当确定优先申请人时，相应的符合性评估或加入ARTG的申请将优先考虑。这意味着TGA将在整个相关评估过程中为应用程序分配“队列前”优先级。

获得优先申请人决定本身并不保证合格评定或列入申请获得批准。这些应用仍然必须根据相关的立法要求进行评估，以发布符合性评估证书，和/或将一种设备纳入ARTG。

有关TGA符合性评估或ARTG纳入申请的更多信息，请参阅标准、指南和出版物（医疗器械和IVD）。

如果没有申请TGA合格评定或ARTG纳入（如相关），优先申请人决定在6个月后失效。

两种类型的优先申请人决定

如果您寻求医疗器械的优先考虑，您只需要申请一种类型的优先申请人确定。

合格评定（优先申请人）确定

如果您需要TGA颁发的合格评定证书，则要申请的相关优先申请人决定是合格评定（优先申请人）裁定。

如果您获得TGA符合性评估，加入ARTG的过程不需要审核，通常在提交纳入申请并支付相关申请费后的短时间内进行。医疗器械（优先申请人）确定的单独申请无需在纳入过程中寻求优先考虑。

医疗器械（优先申请人）确定

如果您不需要TGA颁发的合格评定证书（例如，您可能已经进行了海外合格评定），并且您在纳入过程中寻求优先考虑，则要申请的相关优先申请决定是医疗器械（优先申请人）裁定。

如果您不需要“排队等候”优先考虑（对于您的合格评定申请或纳入申请），您不需要申请确定优先申请人。

立法框架管理医疗器械的相关立法是：

•《1989年治疗用品法》（法案），特别是该法案第4章

•《2002年治疗用品（医疗器械）条例》（条例）。

合格评定（优先申请人）决定和医疗器械（优先申请人）决定的立法框架涉及单独但相当的规定。

该法载有框架条款，其中包括，如果优先申请人的决定生效，则可在该部网站上公布（分别是第41ECA和41FKA节）。