Time Frame for Applying for Class I Medical Device Registration with the Australian TGA

The registration process for a Class I medical device with the Australian Therapeutic Goods Administration (TGA) is generally quick and streamlined, given the low-risk nature of these devices. Here's an overview of the time frame and key steps in the review process:

Time Frame for Application

• Submission: Once you submit your application through the TGA Business Services (TBS) portal, the TGA processes Class I device applications quickly because they are self-declared by the manufacturer.
• Processing Time:
  • For non-sterile, non-measuring Class I devices, the inclusion in the Australian Register of Therapeutic Goods (ARTG) can take as little as a few days to a few weeks.
  • This is because the TGA does not conduct a detailed review of the technical documentation for Class I devices at the time of application. The process mainly involves verifying that the correct information has been submitted and that the application is complete.

Factors That Can Impact Processing Time

1. Completeness of Documentation:

   • Ensuring that all required information (e.g., Declaration of Conformity, device description, sponsor details) is accurate and complete can expedite the process. Missing or incorrect details may cause delays.

2. TGA Workload:

   • While Class I device applications are usually processed quickly, the time frame may be influenced by the TGA's overall workload at the time of submission.

3. Australian Sponsor:

   • If the manufacturer is based outside of Australia, the presence of a well-prepared and experienced Australian sponsor can help speed up the process.

Review Process for Class I Devices

For Class I medical devices, the TGA's review process is relatively simple compared to higher-risk devices (e.g., Class IIa, IIb, or III). Below are the key elements of the review process:

1. Self-Declaration by Manufacturer

• For Class I devices, the manufacturer self-declares that the device meets the Essential Principles for safety and performance, which are similar to international standards (e.g., EU’s CE marking).
• The manufacturer must prepare a Declaration of Conformity, asserting that the device complies with Australian regulatory requirements. This is submitted along with the application, but the TGA does not verify these claims at the time of submission.

2. Submission via the TGA Business Services (TBS) Portal

• The TGA checks that the application contains the necessary details, such as:
  • A description of the device.
  • Manufacturer and sponsor details.
  • The appropriate classification of the device.
  • Submission of the Declaration of Conformity.
• As part of this process, the TGA may also verify that the manufacturer or sponsor has the required Client ID and sponsor ID (if applicable).

3. ARTG Listing (Inclusion in the Register)

• Once the application is complete and all requirements are met, the device is added to the Australian Register of Therapeutic Goods (ARTG).
  • Upon inclusion in the ARTG, the manufacturer or sponsor will receive an ARTG number, indicating that the device is now legally approved for sale in Australia.

4. Post-Inclusion Audits and Compliance

• While the initial registration process is relatively straightforward, the TGA can conduct post-market audits or request technical documentation later on. The TGA may ask for:
  • The full technical documentation (e.g., risk assessments, design details, and manufacturing processes).
  • Evidence of compliance with the Essential Principles.
• If the device fails to meet safety or performance requirements, the TGA can take regulatory action, including suspending or cancelling the ARTG listing.

Summary of Time Frame and Review Process

• Time Frame: The processing time for Class I medical device registration is generally a few days to a few weeks, depending on the completeness of the application and the TGA's workload.

• Review Process:

  • The TGA performs a minimal review for Class I devices, focusing on verifying that the application contains the correct details.
  • No pre-market assessment of the technical documentation is required, as the manufacturer self-declares compliance.
  • Post-inclusion audits may occur, requiring the manufacturer to provide technical documentation upon request.