Class II medical device registration with the Therapeutic Goods Administration (TGA) in Australia refers to the regulatory process that devices in this category must undergo to be approved for use in the Australian market. Class II devices are considered medium-risk and typically require a conformity assessment to ensure they meet safety and performance standards.

Overview of Class II Medical Device Registration

• Definition: Class II medical devices include a wide range of products such as surgical instruments, some diagnostic devices, and products that require clinical evaluation to demonstrate their safety and efficacy.
• Regulatory Framework: The TGA regulates the supply of medical devices under the Therapeutic Goods Act 1989, ensuring that devices meet the required standards for safety and performance.

Steps to Apply for Class II Medical Device Registration

1. Determine Device Classification

   • Verify that your device falls under Class II based on its intended use and risk profile.

2. Prepare Documentation

   • Collect necessary documentation, including:
     • Technical File: Contains detailed information about the device, including design, intended use, manufacturing processes, and risk management.
     • Quality Management System (QMS): Evidence of compliance with ISO 13485 or similar standards.
     • Clinical Evidence: Data demonstrating the safety and effectiveness of the device.
     • Labeling Information: Drafts of device labeling, including user instructions and promotional materials.

3. Select the Appropriate Conformity Assessment Pathway

   • Choose between different pathways based on your device type, such as:
     • TGA Conformity Assessment: For devices that require a higher level of assessment.
     • In-vitro Diagnostic (IVD) Pathway: If applicable.

4. Engage a Conformity Assessment Body (CAB)

   • If required, select and work with a TGA-recognized CAB to assess your device's compliance with relevant standards.

5. Complete the TGA Application Form

   • Access the TGA Business Services portal and fill out the relevant application forms for medical devices.

6. Submit the Application

   • Submit your application along with the necessary documentation and payment of fees through the TGA Business Services portal.

7. Respond to TGA Queries

   • Be prepared to provide additional information or clarification if requested by the TGA during their evaluation process.

8. Receive Registration

   • Once your application is approved, your device will be listed on the Australian Register of Therapeutic Goods (ARTG), allowing you to market and supply the device in Australia.

9. Post-Market Obligations

   • Comply with ongoing obligations related to post-market surveillance, including adverse event reporting and maintaining your QMS.

Resources

• TGA Medical Devices Page: TGA Medical Devices
• TGA Business Services Portal: TGA Business Services

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn