澳大利亚TGA证书办理流程：
在澳洲的备案需要由澳洲当地的SPONSOR(对销售医疗器械负法律责任的个人或公司，通常指经销商)来完成，其合规流程为：
(1)指定SPONSOR：只有通过澳大利亚的代理人才能够提出申请，代理人这里有一个专有名词叫“Sponsor”,简单来说就是进口商。
(2)完成技术文档：低风险的I类器械没有强制性质量体系和上市前评价的明确要求，但要求制造商提供相关文件证明其安全有效性。
(3)提交TGA进行备案;
(4)获得证书。
特别提醒：澳大利亚己与欧盟达成互认协议。这意味着，合格评定证书由TGA颁发的也被欧盟认可，TGA也认可欧盟CE认证。已获CE认证的用户，可提交CE证书及相关资料，获得TGA证书。
IDVEAR公众号
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Tel：0755-33509057
Adress：Building 2, Building B, Building 103-110, Baoxin Science and Technology Park Factory Area, No. 9 Guangyuan Fifth Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province.
E-mail：hitolin@ivdear.com
IVDEAR can undertake the whole process of technical guidance and services such as prospective clinical, who Eul, variant virus research (Delta, Omicron ba.1, ba.2), IVDD CE, ivdr CE, Australian TGA, British CTDA, European HSC common list, European service, British service, etc.
If you have products that have been tested and certified or want to know more about them, please contact IVDEAR！
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