Assistant Manager
Regulatory Affairs | 5.7+ Years of Experience
Overview
Medical Devices and In-Vitro Diagnostics are overseen by the Therapeutic Goods Administration (TGA), a division of the Australian Government’s Department of Health.
Before any medical device can be supplied in Australia, the device must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA).
Official Language: English
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TGA Classification of Medical Devices Australia
Medical devices in Australia are classified based on their intended purpose and associated risk. The classification considers factors such as invasiveness, duration of use, location, and energy source. The classes range from low-risk devices (Class I) to high-risk devices (Class III and Active Implantable Medical Devices – AIMD). Similarly, In-Vitro Diagnostics (IVD) devices are classified based on their intended purpose and the level of public health or personal risk they pose.
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Australia Medical Device Registration Process
Documents Required for Medical Device Registration in Australia
- Medical Device Application: Complete and submit the required application form for the registration of the medical device.
- Technical File: Prepare a comprehensive technical file that includes detailed information about the design, manufacturing process, performance, and safety of the medical device.
- Australian Declaration of Conformity: Provide a declaration stating that the medical device complies with all relevant Australian regulations and standards.
- Manufacturer’s Evidence (CE Certificate): Submit the CE Mark Certificate or any other relevant documentation that demonstrates the compliance of the medical device with the European Union’s regulatory requirements.
- Appointment of Australian Sponsor: If you are a non-Australian manufacturer, appoint an Australian TGA Sponsor who will act as a local representative and assist with the registration process.
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How can Operon Strategist assist you in registering your medical device in Australia?
Are you looking for expert guidance and assistance in navigating the medical device registration process in Australia? Operon Strategist is here to help! Our team of regulatory experts specializes in TGA compliance and can guide you through every step of the registration journey.
Contact us today to ensure a smooth and successful registration process for your medical device in Australia. Let our experienced professionals handle the complexities while you focus on bringing your innovative healthcare solutions to the Australian market.
Don’t miss out on the opportunity to expand your market reach. schedule a consultation with Operon Strategist and get started on your Australian medical device registration journey.
Assistant Manager – Regulatory Affairs | 5.7+ Years of Experience
Medical device regulatory affairs professional specializing in medical device registration, quality management systems, regulatory submissions, and international market access.
