Class I medical device registration with the Australian Therapeutic Goods Administration (TGA) refers to the process by which low-risk medical devices are registered for legal sale and use in Australia. Here’s what it entails:

Key Aspects of Class I Medical Device Registration

1. Definition:

   • Class I devices are considered low-risk and typically include items like bandages, non-invasive diagnostic tools, and simple surgical instruments.

2. Regulatory Framework:

   • The registration falls under the Therapeutic Goods Act 1989 and the Medical Devices Regulations 2002. These regulations establish the requirements for safety, quality, and performance.

3. Self-Declaration:

   • Unlike higher-risk devices (Class II and above), Class I devices do not undergo a detailed pre-market review by the TGA. Manufacturers self-declare compliance with the TGA's Essential Principles, which outline safety and performance requirements.

4. Australian Register of Therapeutic Goods (ARTG):

   • Registration involves listing the device in the ARTG, which serves as an official record of all therapeutic goods approved for supply in Australia. An ARTG number is provided once registration is complete.

5. Requirements for Registration:

   • Manufacturers must prepare documentation, including a Declaration of Conformity, device description, risk management plans, and labeling information. Although the TGA does not review this documentation at the time of application, it must be available for audits.

6. Post-Market Responsibilities:

   • After registration, manufacturers have ongoing responsibilities, including post-market surveillance, reporting adverse events, and ensuring continued compliance with regulatory standards.

Importance of Registration

• Registering a Class I medical device with the TGA ensures that it meets the necessary safety and performance standards, allowing it to be marketed and used in Australia. It also provides consumers and healthcare professionals with assurance regarding the quality of the medical devices they use.

Contact Us：

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