The process for Class I medical device registration with the Australian Therapeutic Goods Administration (TGA) involves a series of steps to ensure that the device meets the Essential Principles of safety and performance. Below is a step-by-step guide on how to register a Class I medical device with the TGA:

Step 1: Determine the Classification of Your Device

• Verify that Your Device is Class I:
  • Medical devices in Australia are classified into different risk categories (Class I, IIa, IIb, III) based on the level of risk they pose to patients.
  • Class I devices are typically low-risk devices, such as bandages, simple wound care products, or non-sterile, non-measuring devices.
  • Refer to Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 to confirm that your device fits the Class I category.

Step 2: Appoint an Australian Sponsor

• If the manufacturer is based outside Australia, you must appoint an Australian sponsor to act as your local representative.
  • The sponsor is responsible for communication with the TGA, ensuring compliance with Australian regulations, and maintaining the device’s ARTG listing.
  • If the manufacturer is in Australia, they can act as both the manufacturer and the sponsor.

Step 3: Prepare the Required Documentation

• Technical Documentation:
  • Although Class I devices are low-risk, you must prepare technical documentation to demonstrate compliance with the Essential Principles for safety and performance. The documentation typically includes:
    • Declaration of Conformity: A statement that your device complies with the Essential Principles. For Class I devices, the manufacturer self-declares conformity.
    • Risk Management Documentation: A report showing how risks have been assessed and mitigated (aligned with ISO 14971).
    • Design and Manufacturing Information: Documentation of the design, materials, and manufacturing processes.
    • Labeling and Instructions for Use (IFU): Details on how the product is labeled and instructions for safe use.
• Quality Management System (QMS):
  • Manufacturers of Class I devices should have a QMS in place, ideally compliant with ISO 13485. While Class I devices do not undergo direct QMS auditing for inclusion, maintaining an organized system is crucial in case of future audits or investigations.

Step 4: Create a Declaration of Conformity

• Declaration of Conformity (DoC):
  • The manufacturer must create a Declaration of Conformity confirming that the device meets the Essential Principles. This document should contain:
    • Manufacturer's name and address.
    • A statement that the device conforms to all applicable regulations.
    • A description of the device (including model numbers if applicable).
    • A reference to the quality system under which the device was designed and manufactured.
    • The signature of an authorized person.
  • For Class I devices, this is a self-declaration, meaning you do not need third-party certification.

Step 5: Apply for a TGA Client ID

• Before you can apply for device registration, you or your sponsor must have a Client ID with the TGA. If you do not have one, you can request it through the TGA Business Services (TBS) portal.
  • If you already have a Client ID, this step is not necessary.

Step 6: Submit the Application Through the TGA Business Services (TBS) Portal

• Register on the TGA Business Services (TBS) Portal:

  • All applications for medical device registration must be submitted through the TBS portal.
  • You will need to create an account, or if you already have one, log in and select the option to submit a new medical device application.

• Device Inclusion Application:

  • Submit the application for inclusion of your Class I medical device in the Australian Register of Therapeutic Goods (ARTG).
  • The application will require details such as:
    • Device classification and description.
    • Manufacturer and sponsor details.
    • Declaration of Conformity.
    • Evidence that the device complies with the Essential Principles.

• Application Fee:

  • As of 2024, there is no application fee for registering Class I devices (non-sterile, non-measuring).

Step 7: Receive Confirmation from the TGA

• TGA Review:
  • For Class I devices, the registration process is straightforward because the TGA does not conduct an in-depth review of the technical documentation at the time of registration.
  • Once you submit your application and it is processed, the device will be included in the ARTG.
• ARTG Number:
  • Upon successful registration, the TGA will issue an ARTG number for your device. This number confirms that your device is listed and can legally be sold in Australia.
• Timeline:
  • The inclusion of Class I devices in the ARTG is generally quick and may be completed within a few days to a few weeks.

Step 8: Ongoing Compliance and Post-Market Obligations

• Post-Market Surveillance:

  • After your device is included in the ARTG, you must continue to monitor its safety and performance through post-market surveillance. This includes reporting any adverse events or incidents related to the device to the TGA.

• Maintain Technical Documentation:

  • Ensure you keep all technical documentation, such as the Declaration of Conformity, risk management reports, and labeling information, up to date and available in case the TGA requests an audit.

• Annual Fees:

  • Pay the annual ARTG listing fee (around AUD 1,080 as of 2024) to maintain the device's registration. Failure to pay the fee may result in cancellation of the ARTG listing.

• Notify the TGA of Changes:

  • If there are significant changes to the device, its intended use, or its manufacturing process, you must notify the TGA, and in some cases, submit an updated application.