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.
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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.
