Medical Device Registration with the Australian TGA

CMC Medical Devices offers medical device and IVD registration with the Australian TGA

We provide Sponsor services in Australia to ensure regulatory compliance and facilitate the entry of your products into the Australian market. CMC Medical Devices PTY LTD supports you as a TGA sponsor and regulatory consultant to ensure compliance with the technical requirements of TGA regulations and post-market compliance.

TGA Sponsor in Australia

Manufacturers of medical devices and IVDs who are not based in Australia must select a representative in the country, known as an Australian Sponsor or TGA Sponsor.

Your TGA Sponsor plays a crucial role in the device registration process and post-market compliance, so it is important to select an independent and highly qualified representative.

CMC acts as a professional sponsor for medical device and IVD companies located worldwide.

The Sponsor acts as a liaison between you and the Therapeutic Goods Administration (TGA), as specified by the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. The Sponsor assumes the regulatory representation of the product in the Australian market and is responsible for registering your device with the TGA.

To maintain control over your device and IVD registration, we recommend that you designate a “third-party” sponsor who is not commercially involved in the sale of your products and acts solely as your regulatory representative in Australia.

Our functions as a TGA Sponsor for Australia

  • Register your medical device(s) and IVD(s) with the TGA before commercialization.
  • Act as your primary point of contact with the TGA.
  • Ensure that your technical file is available for inspection by the TGA.
  • Authorization to place our name and address on the labels, packaging, instructions for use, etc. of your device.
  • In-house regulatory experts to liaise between you and the TGA.
  • Assistance with surveillance: Reportable recalls/Adverse events reporting to the TGA, in cooperation with you and your distributors.
  • Protection of your confidential documentation: the Sponsor may only show it to the TGA.
  • Represent you before the TGA for consultation in case of a medical device recall.
  • Secure online access to information and labeling symbols, technical file templates, quality system procedures (QSP or SOP), medical device regulations, surveillance guidelines, classification guidelines, market recalls/reportable adverse events, harmonized standards, and more.

Select CMC as Your TGA Sponsor in Australia

Complete the contact form and one of our consultants will get in touch as soon as possible.

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Frequently asked questions about TGA Registration

No, while the sponsor ensures that the products comply with Australian regulations and manages communication with the TGA, the foreign manufacturer is ultimately responsible for the quality and safety of their products.

Yes, your distributor or any other individual/entity based in Australia can act as your TGA sponsor. However, it’s essential that they are qualified and willing to assume the regulatory responsibilities associated with this role.

The cost varies depending on the sponsor’s services and the type of therapeutic goods being registered. It’s important to choose a reliable sponsor who can ensure compliance with TGA regulations.

Without a TGA sponsor, your company cannot legally supply therapeutic goods in Australia. The sponsor is the official point of contact and is required for regulatory approval, ongoing compliance, and communication with the TGA.

Why appoint CMC Medical Devices as your TGA Sponsor?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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