澳大利亚的医疗设备注册

澳大利亚医疗器械的分类 

在澳大利亚，医疗设备按照澳大利亚治疗用品（医疗器械）规定为2002年进行分类。医疗器械根据其预期目的进行分类。特别是，分类规则考虑人体中的侵入程度，持续时间使用，使用位置以及器件是否依赖于身体或重力以外的能量源。  

Different Device Classes and Associated Risk: 

Class	Risk
Class I	低的
I类（提供无菌）	低的-medium
Class I (incorporating a measuring function)
级别
IIB类	Medium-high
III级	High
AIMD（有源植入医疗设备）	High

IVD医疗器械的分类： 
IVD medical devices are classified based on their intended purpose and the health risk or personal risk that may arise from an incorrect result. 

Class	Risk
1级IVD	No public health risk or low personal risk
Class 2 IVD	低的public health risk or moderate personal risk
Class 3 IVD	Moderate public health risk or high personal risk
Class 4 IVD	High public health risk

阅读更多文章-9个不同国家的医疗设备注册指南（OperonStrategy.com）

Australian TGA Sponsor 

Medical device or IVD manufacturers which are not based in Australia are obliged to have in-country representative, called an Australian Sponsor or TGA Sponsor. TGA Sponsor plays vital role in medical device registration in Australia process and post-market compliance by acting as a liaison between the manufacturer and the TGA. Australian TGA Sponsor’s name must appear on device and labelling. 

 基本原则 
制造商需要演示compliance with the essential principles before applying for inclusion on the Australian Register for Therapeutic Goods (ARTG). These essential principles put forth the fundamental design and manufacturing requirements for medical devices. There are six general essential principles that apply to all devices (relating to health and safety, including long-term safety, with benefits outweighing the risks), and a further nine essential principles about design and construction that apply to devices on a case-by-case basis. Six general essential principles include the following:  

• Medical devices should follow the prescribed measures of health and safety.
• Medical devices are needed to design and construct as per the safety norms.

• Medical devices needs to demonstrate their intended purpose 
• 他们需要长期更安全。 
• Due to transport or storage medical devices should not be adversely affected.
• 医疗器械的好处超过了任何不良影响。 

Pre-market Assessment: Conformity Assessment of Medical Devices  

符合性评估是对证据和程序的系统和持续审查，以确定医疗器械的安全是可接受的，并且设备按预期执行，因此，符合基本原则。基于设备分类，必须选择适当的符合性评估路由。已经拥有CE认证的设备在欧洲通知机构在满足TGA要求方面具有更多优势。TGA考虑了医疗器械单一审计计划（MDSAP）审计报告，以来，澳大利亚是参加MDSAP的合作伙伴之一。 

市场授权：在艺术中纳入医疗器械 

• Inclusion of lower risk devices in the ARTG 
  对于没有测量功能的I类医疗设备，不旨在提供无菌，因此必须提交制造商对设备的符合性符合性声明的副本，必须包括在ARTG中包含设备。这些设备的赞助商还必须能够根据请求提供其他文档（例如，标记，使用和设备性能的使用证明，等待）到TGA。 
• Inclusion of all other devices in the ARTG (Except lower risk) 
  任何申请纳入ARTG中的医疗设备必须包括申请表所需的特定信息，包括来自TGA或其他可比海外监管机构的符合性评估认证以及产品评估的证据。TGA可以基于应用程序中提供的信息批准在ARTG中包含一个设备，或者TGA可以选择审计评估的应用程序。如果TGA批准，那么将发出Anaustalian的治疗货物（ARTG）上市人数。 

Post Market Assessment of Medical Devices 
Once a device is approved, manufacturers must continue to monitor the performance and safety of their devices and ensure continued compliance with the essential principles. The data generated from safety and adverse event reports, complaints, newly identified risks, literature, new clinical investigations, significant regulatory actions and other surveillance activities such as registries must be used by the manufacturer to review the performance, safety and benefit-risk assessment of the device. 在澳大利亚的简要医疗设备注册中，如果制造商希望合法提供，则设备需要包含在Artg中。

For the medical device registration in Australia, manufacturer should check whether their product is with the relevant guidelines or not, the entire process may need 3 to 8 weeks or more depending upon the product specifications. The manufacturer need to be aware of their financial and legal responsibility.