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Asia Pacific

Set Alert for Asia Pacific

Nexsen Targets Clinical And At-Home Markets With Rapid Diagnostic For GBS Infection

Australia-based Nexsen BioTech is developing StrepSure, a rapid lateral flow test for detecting Group B Streptococcus (GBS) infection in pregnant women. Designed to provide results within 15 minutes, with the potential to save "millions of babies’ lives,” StrepSure will be assessed in a 5,000-patient clinical trial targeted for summer 2025, which will support Australia and US submissions for market authorization. Thomas Hanly, Nexsen managing director, discusses. 

Europe United Kingdom

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

Greater Bay Area Device Adoption Can Be A Steppingstone To China Uptake

Medical devices from Hong Kong and Macao selected for use in the Guangdong-Hong Kong-Macao Greater Bay Area may potentially be fast-tracked for adoption across mainland China, according to a new industry white paper.

China Hong Kong

Global Medtech Guidance Tracker: May 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.

International Guidance Documents

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

Australia Clinical Trials

Regulatory Reliance: Thai Program With Singapore Provides Cost-Savings, Earlier Innovations

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.

Thailand Singapore

New China Tariffs Include Higher Rates For Syringes, PPE

Medical products imported from China are among a broad range of items that will be subject to higher tariffs under new federal guidelines. The plan will raise tariffs on some forms of personal protective equipment (PPE) to 25%; additionally, tariffs on syringes and needles will be set at 50%.

Trade Policy Regulation

Global Medtech Guidance Tracker: April 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Australia Calls For Companion Testing Plans For Drugs Requiring A CDx

An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.

Australia Guidance Documents

Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

Manufacturing OTC Devices

Medtechs Must Reflect On China Localization Policies As VBP Expands

China continues to roll out volume-based procurement for medical devices and pharma products and companies should plan their strategies accordingly, advises EY Parthenon’s Hua Su.

China Pricing Strategies

Australia Cuts Regulatory Burden Of Product Recalls

The Therapeutic Goods Administration says it has made a series of improvements in areas such as the recall and stakeholder communication process, reporting requirements, and the agency’s guidance materials.

Australia Recalls

Global Medtech Guidance Tracker: March 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.

Guidance Documents Regulation

China Localization – VBP Sees Global Medtechs Ponder Stay Or Exit

It is the time of year when global healthcare industry CEOs descend on China's capital to discuss strategies. A change of mood is evident among medtechs and pharmas.

China Policy

FDA Leader Looks To International Effort On Pediatric Device Development

Collaboration with Japan and Europe could help ease the development path for pediatric devices, cardiovascular device office director Bram Zuckerman said at a recent conference. Zuckerman also spoke on other cardiac device priorities at the FDA.

FDA Innovation

A More Cautious Approach To AI, And Other Policy And Regulation Trends From HIMSS 24

Risk-based AI regulations and data modernization are just a few of the top policy priorities from thought leaders attending the largest health care technology professional gathering in the world. 

Digital Health Policy
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