Asia

South Korea’s Regulatory Science Council Targets Enhanced Standards

 
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The head of the Korea Regulatory Science Center discusses why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.

Global Medtech Guidance Tracker: September 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

China Moves From Administrative Orders To Medtech Law – Consultation Underway

 
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After high-level deliberations, a draft Medical Device Administration Law to supersede the series of medical devices administrative orders has been issued by the Chinese State Food and Drug Administration. A stakeholder consultation is underway.

Medtech Warming Up To Benefits Of Australia’s Teletrials Initiative

 
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The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.


Global Medtech Guidance Tracker: August 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

Bleep Bloop Blood: Vitestro’s Automated Blood-Drawing Robot Cleared For EU Market

 

Vitestro's automated blood drawing robot received CE marking on August 28. The company is limiting release of the robot over the next 12 months to a small number of selected hospitals, with plans to scale up production thereafter.

Global Medtech Guidance Tracker: July 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.

Inspections Of Chinese Syringe Manufacturer Prompts Additional Warnings

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.


Trunzo: ’We’ve Come A Long Way To Get To Regulatory Reliance’

 
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Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.

Quantum Surgical Plans Expansion In Asia, Additional EU, US Indications For Oncology Surgical Robot Epione

 

Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.

EU Confidence In China Market Still On Downward Trend

 
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The anticipated business rebound for China after its post-COVID reopening of markets in 2023 has not materialized and structural market issues continue to affect EU firms' China sentiment.

China Market For Medtech: Opportunity Or Headache?

 
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Medtech companies have typically seen a “mixed picture of growth” in China in the past year or two, but it is a market that requires ongoing commitment, a panel of experts argued at the MedTech Forum 2024.


Global Medtech Guidance Tracker: June 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

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. 

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.

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

 
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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.


Global Medtech Guidance Tracker: May 2024

 
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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.

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.

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

 
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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.

New China Tariffs Include Higher Rates For Syringes, PPE

 
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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%.