In the ever-evolving landscape of healthcare, the safety and efficacy of medical devices are paramount. In Australia, the Therapeutic Goods Administration (TGA) stands as the vigilant guardian, overseeing the registration and regulation of medical devices that impact public health. Let's delve into the intricacies of medical device registration in Australia and unravel the pivotal role played by the TGA.
This white paper focuses on Classification of medical devices in Australia, conformity assessment and MDSAP requirements, Document and Sponsor Requirements for Medical Device Registration in Australia along with detailed registration pathway of medical devices in Australian market and the role of Australian Sponsor. Authored by our expert Pawan Sadhnani, this comprehensive guide provides essential knowledge for a successful registration process. Elevate your understanding today by downloading this insightful resource
Pawan Sadhnani
Expert, Freyr Solutions
Pawan Sadhnani is an accomplished Strategy Consultant specializing in the Medical Device, SaMD (Software as a Medical Device), and IVD (In Vitro Diagnostics) domains. His commitment lies in delivering comprehensive end-to-end regulatory solutions, guiding organizations through complex compliance landscapes for successful market access and global expansion.
Pawan excels in crafting tailored regulatory strategies that cater to the unique needs of healthcare industry stakeholders. He adeptly navigates organizations through intricate compliance requirements, ensuring seamless transitions and strategic implementations.
