Australia Therapeutic Goods Act 1989
Medical Device Registration in Australia
Achieving regulatory compliance with the Therapeutic Goods Act 1989. Qserve can support you with registering and maintaining medical devices and IVDs with the Therapeutic Goods Administration (TGA) in the Australian Register of Therapeutic Goods (ARTG).
Australia's hospitable innovation environment opens the door for pioneering medical device creators. The Therapeutic Goods Administration (TGA) welcomes overseas innovators, accepting regulatory approvals from the EU or the US, enabling you to leverage your existing approvals seamlessly. Qserve guides the process for Medical Device Registration in Australia.
Regulatory Compliance in Australia
Medical Device Registration in Australia
Our regulatory consulting specialists support market access in the Australian medical device market. Based on your existing technical documentation, they can do a gap assessment to determine the overlap and possible missing elements. We know the essential requirements to receive TGA approval and can set up a strategy plan with you to guide the Medical Device Registration process in Australia.
Benefits of Qserve engagement
Worldwide support
- Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
- We specialize in helping clients achieve and maintain market access around the world.
- Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
- Qserve uses a practical approach to support you every step of the way.
Do you need assistance with Medical Device Registration in Australia or go-to-market strategy?
Qserve is your trusted partner for market access in Australia.
Contact us