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

Step-by-Step Guide for Class I Medical Device Registration

1. Confirm Device Classification

• Ensure your device qualifies as a Class I medical device. Class I devices are considered low-risk, such as simple non-invasive instruments or products like bandages. Review the Australian Therapeutic Goods (Medical Devices) Regulations 2002 for classification guidelines.

2. Appoint an Australian Sponsor (if needed)

• If you are an overseas manufacturer, you must appoint an Australian sponsor who will act as the local representative. The sponsor:
  • Must have an Australian address.
  • Is legally responsible for submitting the application and ensuring compliance with TGA regulations.

3. Prepare Required Documentation

While the TGA does not review technical documentation for Class I devices during the registration process, you need to prepare it and have it ready for potential post-market audits. Required documentation includes:

• Declaration of Conformity: A formal statement that your device complies with the Essential Principles (safety and performance).
• Device Description: A clear description of the device, including its design, materials, and intended use.
• Risk Management Plan: Documentation proving that you have identified and mitigated risks associated with the device.
• Labeling and Instructions for Use (IFU): Proper labeling and instructions for use must be included, explaining the safe usage of the device.

4. Obtain a TGA Client ID

You must have a TGA Client ID to submit an application. If you do not already have one, you can apply for a Client ID via the TGA Business Services (TBS) portal.

5. Submit Application via the TGA Business Services (TBS) Portal

• Log in or register on the TGA Business Services portal.
• Select Medical Device Application: Choose the option for applying for Class I device registration.
• Complete the Online Application:
  • Provide the necessary details, including the device’s description, classification, manufacturer, and sponsor details.
  • Submit your Declaration of Conformity.
  • Ensure all information is correct before submitting the application.
• No Application Fee: For non-sterile, non-measuring Class I devices, there is no application fee required.

6. Receive ARTG Number

Once the TGA processes your application (usually within a few days to a few weeks), the device will be added to the Australian Register of Therapeutic Goods (ARTG). You will receive an ARTG number, signifying that the device is now legally approved for supply in Australia.

7. Post-Market Obligations

• Post-Market Surveillance: After registration, you must monitor the safety and performance of the device.
• Adverse Event Reporting: Any adverse events must be reported to the TGA.
• Maintain Documentation: Be ready to provide technical documentation if requested by the TGA during a post-market audit.

8. Pay Annual ARTG Listing Fees

• There is an annual charge (around AUD 1,080 as of 2024) to maintain the ARTG listing for the device.
• Failure to pay the annual fee may result in the cancellation of the registration.

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