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Asia Pacific

Set Alert for Asia Pacific

Australia Consults On Stricter Rules For Personalized And 3D-Printed Devices

The strict regulatory oversight that applies to conventionally produced implants would also start applying to similarly high-risk 3D printed implants under new proposals from Australia's Therapeutic Goods Administration.

Australia Policy & Regulation Medical Device
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#APMTF2017: Insights On Innovation – Soundbites From APAC Medtech Forum 2017

The third edition of the Asia-Pacific Medtech Forum took place this week on Nov 7-9 in Singapore and included a solid line-up of speakers from industry, as well as regulatory and government authorities and thought leaders. Medtech Insight was at the event, busy Tweeting choice soundbites from the likes of Baxter International's José Almeida, Boston Scientific's Michael Mahoney, Microsoft's Simon Kos, Verb Surgical's Scott Huennekens and Japan's vice-minister of health at Japan's Ministry of Health, Labour and Welfare Yusuhiro Suzuki, among other notable figures.

Asia Pacific Market Access

India Settles On Classifications For Nearly 600 Devices, IVDs

The final list of medical devices and IVDs classifies products according to India’s imminent new rules for medtech products. It contains about 100 fewer entries than the original draft issued in June.

Asia Pacific India

Growing Medtech Ecosystem In Asia-Pacific Makes Fertile Ground For Disruption

The annual Asia-Pacific MedTech Forum will take place this week on Nov 7-9 in Singapore, boasting a line-up of speakers that includes leaders of medtech's big players and heads of their APAC businesses. Innovation is the overarching theme for the third edition of the event, highlighting how far some of the countries in this region have come in terms of developing a strong medtech ecosystem that encourages a disruptive, entrepreneurial culture. On the eve of the meeting, Medtech Insight caught up with Fredrik Nyberg, CEO of APAMed, the Asia Pacific medical device industry association and key organizer of the forum, for a quick chat about the region's changing medtech landscape and APACMed's role in facilitating this change.

Asia Pacific Market Access

India-US Tensions Grow In Device Pricing Cap Controversy

India's price capping for medical devices is threatening to snowball into a trade tit-for-tat with the US. The US Trade Representative is intervening on the matter at the behest of industry. While a middle path is probably still possible, pro-health groups in India have decried the “reprehensible” US move, and others are suggesting a tax on US luxury goods should the issue escalate.

Policy & Regulation United States

Asia Reg Roundup: Vietnam's Medtech Filers Under More Deadline Pressures

Stakeholders aired concern in Vietnam this summer about the amount of time available for companies to meet the new national device regulatory system's July 1 deadline for class A, lowest-risk, medical device applications. There are now worries over whether the next deadline, December 31, will be met for the higher-risk category devices, according to local experts Jack Wong and May Ng in this regional update that also includes updates from Malaysia, Bangladesh and Hong Kong.

Asia Pacific Regulation

China's High Demand For Aesthetic Solutions Brings Attractive Opportunities

China is the world's third largest market for aesthetic devices and the value of this market is expected to exceed $20bn by 2020. To fully capitalize on this opportunity, Israeli maker and one of the leading suppliers of energy-based devices to the country, Sisram Medical, is looking to grow its portfolio through acquisitions and in-house R&D.

Aesthetics China
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