TGA Registration in Australia
Medical device manufacturers must register in the Australian Register of Therapeutic Goods (ARTG) supervised by the Therapeutic Goods Administration (TGA) before exporting any medical devices to Australia. SUNGO has an office in Melbourne, which can help enterprises register medical devices with TGA, so that their products can be exported to the Australian market smoothly.
Medical device classification in Australia
TGA uses a four-level classification system. Based on the hazards to the human body, the risks are divided into Categories I (including sterile and measurement devices), IIa, IIb and III. Australia’s classification rules are almost the same as those of the EU. Like the regulatory systems in most countries, TGA’s regulatory control of medical devices is enhanced with the increase of risk levels.
Representatives of foreign manufacturers in Australia - sponsors
Each company that does not have a fixed place of business in Australia must appoint a representative in Australia, i.e. the sponsor. The sponsor is responsible for medical device registration and after-sales activities, such as adverse event reports and product recalls. The name and address of the Australian sponsor must appear on the device label. Generally speaking, the sponsor is a supplier, that is, an individual or entity that imports products from overseas to Australia. The sponsor needs to control the quality and compliance of the packaging, labels, advertising materials and products in every batch of goods entering Australia and bears legal responsibility.
Registered agents in Australia
Medical device manufacturers must register in the Australian Register of Therapeutic Goods (ARTG) supervised by the Therapeutic Goods Administration (TGA) before exporting any medical devices to Australia. The agents can help the manufacturers or related parties register in the ARTG, and provide related technical support.
Services provided by SUNGO
SUNGO has an experienced TGA registration team that can help you successfully enter Australia’s booming medical device market. Our consultants have rich experience in conducting conformity assessment for various device types. We can provide the following services:
· Determine the classification of your device.
· Evaluate the requirements for your device to be registered with TGA.
· Research the correct GMDN code for your medical device.
· Prepare the TGA technical documentation.
· Perform the technical documentation review to ensure the completeness and compliance.
· Submit the device to TGA for registration.
For anti-epidemic products, SUNGO can act as an agent, providing relevant technical services and ultimately helping the enterprises complete the TGA registration. For other products, SUNGO can provide temporary sponsor services during the registration, providing relevant technical support for the enterprises and helping them finally complete the registration. After the registration is completed, each enterprise needs to find a suitable sponsor as soon as possible and complete the transfer to the sponsor.
TGA registration process
Step
Specific task
SUNGO’s service
1
Determine the classification according to Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002. If the device has been CE certified, the classification may be the same. TGA usually recognizes the CE certificate from a European notified body.
SUNGO can serve as an agent to provide classification confirmation and declaration path confirmation services.
2
If you do not have a local office in Australia, designate an Australian sponsor to act as the liaison between the manufacturer and TGA, and the sponsor’s name and address must appear on the device label.
If you have a sponsor, SUNGO can provide the agent services, assisting you in completing the registration.
3
Prepare the technical documentation, declaration of conformity, and other materials to be submitted for registration.
SUNGO can act as the agent to provide the technical services such as writing the related technical documentation and drafting the declaration of conformity.
4
For all the devices except the Class I non-sterile and non-measurement devices, the manufacturer’s conformity certification materials (such as CE certificates) must be submitted in the eBS system for TGA’s review.
SUNGO can act as the agent to submit the application materials in the eBS system.
5
Class III medical devices will be subject to Level 2 application review. The design documents need to be reviewed by TGA.
SUNGO can act as the agent to provide the technical support.
6
For all types of medical devices, registration applications shall be submitted online in the eBS system. The application shall include the intended use, classification and GMDN code, and the application fee shall be paid.
SUNGO can act as the agent to submit the application materials in the eBS system.
7
TGA may approve or reject your application. If approved by TGA, TGA will issue an ARTG listing certificate, and your listing will be published in the ARTG database on the TGA website.
SUNGO can act as the agent to assist you in obtaining the registration certificate.
8
After the registration is completed, your products can be exported to Australia successfully.
SUNGO can act as the agent to provide technical services for the compliance issues you encounter in post-market surveillance.
9
TGA will collect the annual fee for the next fiscal year in July each year. TGA will send the annual fee bill to your sponsor, and the sponsor will make the payment to TGA.
SUNGO can act as the agent to assist you in completing the annual update.
