PERTH, Australia – With half the world’s population, Asia Pacific is quickly replacing Europe as the world’s second-largest medical device market, and China, Korea and Australia stand out as leaders, said Tim Schmid, company group chairman for Johnson & Johnson Medical Devices, Asia Pacific, during the recent Ausmedtech 2021 virtual conference.

HONG KONG – Genetron Holdings Ltd. is teaming up with JD Health International Inc. to develop full-cycle cancer management solutions encompassing both online and offline components. The partnership will focus on the six key areas of consumer health care, digitization of liver disease management, government medical associations, sharing of customer screening resources, industry, and user education as well as the consolidation of oncology doctors and experts on a single platform.

PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).

HONG KONG – Dia Imaging Analysis Ltd. has teamed up with Sonoscape Medical Corp. to deliver cardiac ultrasound artificial intelligence (AI) solutions. The partnership aims to reduce the variability associated with manual or visual analysis, and increase efficiency and accuracy throughout the analysis process. As a result, China-based Sonoscape's ultrasound devices will be offering a layer of automated AI-based analysis to support the clinician’s decision-making process, courtesy of Dia's AI-based cardiac solutions.

PERTH, Australia – The launch of Australia’s first medical device development and manufacturing facility in Melbourne is set to fast-track new treatments for people with conditions such as epilepsy, Parkinson’s disease, hearing loss, stroke and diabetes.

PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.

HONG KONG – The Vietnamese Ministry of Health (MoH) has published a draft decree intended to refine the legal framework for regulating medical devices in the country. Released under the title Official Dispatch No. 2271/BYT-TB-CT, the draft document consolidates the amendments made to the current decree and introduces new sections addressing clinical trials, the Essential Principles for Safety and Efficiency of Medical Devices, and advertising.

HONG KONG – The revisions for China’s Regulations for Supervision and Administration of Medical Devices, which promise harsher penalties and post-market enforcements, will come into effect on June 1, 2021. The revisions see authorities take a more progressive and aggressive approach to the regulatory enforcement of medical device products in China.