Service Scheme for Medical Device
Export to Australia
I. If you are a manufacturer
1. We will determine the classification and the declaration path based on the product information provided by you, such as the product name and intended use, in accordance with Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
2. If you have a local office or distributor in Australia to act as the sponsor for your products, we will serve as an agent to help you register. If you do not have a local office or distributor in Australia to act as the sponsor for your products, you need to appoint a representative in Australia to be the sponsor. We will serve as an agent to help you complete the registration.
3. You need to sign a consulting contract with us and pay the service fee.
4. You should prepare and submit the technical documentation, declaration of conformity, and other materials for registration.
5. After the registration is completed, TGA issues an ARTG listing certificate.
6. Your products can be normally exported to Australia.
7. You need to keep export-related records and provide them for your sponsor for review by TGA.
II. If you are a trader
1. We will determine the classification and the declaration path based on the product information provided by your manufacturer, such as the product name and intended use, in accordance with Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
2. If you have a local office in Australia to act as the sponsor for your products, we will serve as an agent to help you register. If you do not have a local office in Australia to act as the sponsor for your products, you need to appoint a representative in Australia to be the sponsor. We will serve as an agent to help you complete the registration. In such a case, the ownership of the registration shall remain with the sponsor.
3. You or the interested party need to sign a consulting contract with us.
4. You should prepare and submit the technical documentation, declaration of conformity, and other materials for registration.
5. After the registration is completed, TGA issues an ARTG listing certificate.
6. Your products can be normally exported to Australia.
7. You need to keep export-related records and provide them for your sponsor for review by TGA.
III. If you are an OEM
1. We will determine the classification and the declaration path based on the product information provided by your manufacturer, such as the product name and intended use, in accordance with Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
2. If you have a local office in Australia to act as the sponsor for your products, we will serve as an agent to help you register. If you do not have a local office in Australia to act as the sponsor for your products, you need to appoint a representative in Australia to be the sponsor. We will serve as an agent to help you complete the registration. In such a case, the ownership of the registration shall remain with the sponsor, and the OEM shall be authorized by the sponsor.
3. You or the interested party need to sign a consulting contract with us.
4. You should prepare and submit the technical documentation, declaration of conformity, and other materials for registration.
5. After the registration is completed, TGA issues an ARTG listing certificate.
6. Your products can be normally exported to Australia.
7. You need to keep export-related records and provide them for your sponsor for review by TGA.
Quotation Scheme for Medical Device
Export to Australia
Quotation principle for TGA services in Australia
The quotation for TGA services in Australia mainly considers the product risk levels and the responsibilities we need to undertake.
1) Determine the product risk levels;
2) Determine whether we should become a temporary sponsor or only act as an agent;
3) Determine whether the enterprise needs us to prepare the technical documentation meeting the TGA requirements.
