On November 29th, 2022, MGI robotic ultrasound system MGIUS-R3 was granted access to the Australian market by Australia's Therapeutic Goods Administration ("TGA"). This marks another milestone in MGI's international footprint followed by the China NMPA qualification and European CE certification in 2020, allowing it to enter the Chinese and EU market to provide state-of-art long-distance ultrasound diagnostic services.
Australia is well-known for its rigorous standards in the production and import of medical devices, recognized as one of the countries with strict regulations and great market access difficulty in the world. The TGA certification proves MGI's robotic ultrasound system meets the TGA standards in the quality system and manufacturing facilities. This also means that the robotic ultrasound system officially enters the Australian market, providing local users access to the innovative ultrasound technology.
MGIUS-R3 is the world's first ultrasound device that enables doctors to make diagnoses by remotely controlling the ultrasound probe. The product combines robotic technology, remote real-time control system and high-resolution ultrasound imaging. Its humanized design can enable both doctor and patient to achieve real-time communication through the interactive screen, and its flexible manipulator system can simulate manual operation throughout the process to perfectly reproduce expert techniques.
MGI is committed to playing its part to "lead life science innovation". The success in obtaining the TGA certification speaks volumes about MGI's innovation in ultrasonic devices. With international qualifications TGA certification, NMPA qualification and European CE certification MGI's product portfolio provides more high-quality services to patients all over the world, especially for those areas with scarce medical resources.