2026-07-27
Qualtech's recent webinar provided practical insights into medical device market entry in Australia and New Zealand, covering Australia's ARTG inclusion process, post-market obligations, new UDI requirements, and New Zealand's WAND notification framework. The session also highlighted key regulatory updates and practical considerations for manufacturers planning expansion into the ANZ market.
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2026-07-28
Starting July 2026, the Australian Therapeutic Goods Administration (TGA) will implement an overall increase in regulatory fees and annual charges for medical devices and in vitro diagnostic (IVD) devices. This article provides a detailed 2025 versus 2026 fee comparison, highlighting an upward adjustment of approximately 4.7% to 6.3% across various submission and maintenance categories. It also includes strategic insights from Qualtech on leveraging overseas approvals and managing hidden compliance costs to optimize long-term operational budgets and market access strategies
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2026-07-27
HSA has recently stepped up its efforts to combat illegal and unregistered health products through both consumer advisories and enforcement activities. In its latest announcements, HSA warned against the online purchase of contact lenses and reported the removal of 959 illegal health product listings, with unregistered contact lenses accounting for over 82% of the cases. The authority also reminded sellers that non-compliance may result in enforcement actions, including product seizures, investigations, prosecution, fines and imprisonment. These developments highlight Singapore's continued focus on protecting public health and strengthening oversight of regulated medical devices.
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