To apply for Class I medical device registration with the Australian Therapeutic Goods Administration (TGA), follow these steps:

1. Confirm Classification

• Ensure your device is classified as Class I (low risk) under the Australian medical device classification rules.
• Class I devices are typically non-invasive and low-risk, such as bandages or surgical instruments.

2. Ensure Compliance with Essential Principles

• Ensure your device meets the Essential Principles for safety and performance as per the Australian regulations.
• Prepare the technical documentation demonstrating compliance, such as design, risk management, and clinical evaluation documentation.

3. Obtain Manufacturer's Evidence

• If you are not the manufacturer, obtain a Manufacturer’s Declaration of Conformity and other necessary evidence, confirming the device complies with regulatory requirements.
• For domestic manufacturers, the manufacturer must have a Conformity Assessment Certificate.

4. Create a TGA Business Account

• Register for a TGA Business Services (TBS) account, which allows you to interact with the TGA for submissions and fees.
• You will need an Australian Sponsor (an individual or company responsible for regulatory compliance in Australia).

5. Submit Manufacturer’s Evidence

• Upload the manufacturer’s evidence to the TGA through the TBS portal. This includes the declaration and any other relevant certificates or reports.

6. List the Device on the ARTG

• Once the manufacturer’s evidence is accepted, proceed with submitting an application to list your device on the Australian Register of Therapeutic Goods (ARTG).
• Class I devices can generally be self-declared without requiring direct review from the TGA (unless they are sterile or have a measuring function, which would be Class Is or Im).

7. Pay the Fees

• Pay the required application fees for the listing. Note that Class I devices have the lowest fees among medical devices in Australia.

8. Maintain Compliance

• After listing, the device and manufacturer must continue to comply with post-market surveillance and ongoing obligations, including adverse event reporting and annual compliance checks.

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