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AUSTRALIAN TGA SPONSER
An Australian TGA sponsor is a legal entity or individual appointed by a non-Australian manufacturer of therapeutic goods. Their role is to ensure regulatory compliance with the Therapeutic Goods Administration's (TGA) requirements for marketing and selling the manufactured products in Australia.
The TGA is a regulatory body tasked with ensuring the safety, quality, and efficacy of therapeutic goods in Australia.
Non-Australian manufacturers of medical devices and in vitro diagnostic (IVD) products, not physically located in Australia, are required to appoint a representative in Australia. This representative, known as an Australian TGA sponsor, is a legal entity or individual appointed by the non-Australian medical device manufacturer to ensure regulatory compliance and serve as a liaison with the Therapeutic Goods Administration (TGA) on behalf of the manufacturer.
The Australian TGA sponsor plays a crucial role in facilitating the entry process, managing the Device Registration process, ensuring post-market compliance, and overseeing the supply of therapeutic goods in the Australian market.
Amstermed Australia PTY LTD specializes in offering comprehensive sponsorship services to medical device and in vitro diagnostic (IVD) manufacturers in Australia.
With a profound understanding of the Therapeutic Goods Administration (TGA) regulatory framework, we provide customized solutions to assist you in navigating the intricate approval process and successfully launching your products in the market.
As your sponsor, Amstermed Australia takes on the responsibility of product registration, ARTG listing, monitoring, reporting adverse events, and ensuring compliance with other regulatory requirements. We actively engage with the Therapeutic Goods Administration on behalf of the non-Australian manufacturer, facilitating effective communication throughout the regulatory process.
1
Regulatory compliance
Ensuring compliance with TGA regulations for medical devices and IVDS.
2
Application submission
Preparing and submitting accurate and complete applications for inclusion in the ARTG.
3
Post-market surveillance
Monitoring the safety and performance of products and reporting adverse events to the TGA.
4
Labeling and advertising compliance
Reviewing and approving product labelling and advertising materials for regulatory compliance.
5
Liaison with the TGA
Acting as the primary contact for communication with the TGA and providing requested information.
6
Compliance with regulatory changes
Staying up-to-date with TGA regulations and promptly implementing necessary adjustments.
7
Post-market obligations
Fulfilling post-market obligations, including monitoring, recalls, corrections, and reporting.
8
Record-keeping
Maintaining accurate and comprehensive documentation related to regulatory approvals and post-market activities.
9
Cooperation with authorities
Collaborating with the TGA during regulatory inspections or audits.
