PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).

HONG KONG – Singapore-based X-Zell Biotech Pte. Ltd. has emerged as the winner of the Medtech Innovator Asia Pacific 2020 Accelerator program, as determined by a live virtual audience vote. Winning the competition, organized by Medtech Innovator and the Asia Pacific Medical Technology Association (APACMed), earned X-Zell a $150,000 non-dilutive grand prize to advance its business goals and mission.

PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.

KARACHI, Pakistan – Pakistan is taking steps to produce coronary stents domestically as a way to improve the delivery of health care at home and, perhaps, tap into a growing global market. N-ovative Health Technologies Pvt. Ltd., spun out of the National University of Science and Technology (NUST), started mass production of cardiac stents and angioplasty balloon catheters in October. It is the first such manufacturing facility in the country.

PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.

HONG KONG – Los Angeles-based medical device accelerator Medtech Innovator and Asia Pacific Medical Technology Association (APACMed) have picked five finalists to compete for the title of the 2020 Asia Pacific Grand Prize winner, out of more than 170 applicants. Cartosense, Healthy Networks, Remidio, Sporogenics, and X-Zell were selected for the Medtech Innovator Asia Pacific competition, now in its second year.

PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test. A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test.

Taiwan’s FDA rolled out two new supplementary regulations on periodic safety updates and adverse event notifications for medical devices in October. They are part of its Medical Device Management Law that was reported on Jan. 15. As Taiwan is stepping up innovation of and regulation for medical devices, the nation for the first time decided to separate the regulation of medical devices from pharmaceutical products.

HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration.