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As we step into the brisk embrace of November, we are excited to extend a warm welcome to our valued partners, clients, and friends in the healthcare ecosystem.
This edition of the Access-2-Healthcare Newsletter arrives with a harvest of insights, regulatory updates, and upcoming events to empower you in the dynamic world of medical devices. We extend our sincere appreciation for your trust in Access-2-Healthcare to achieve your milestones and overcome your challenges together. We are shaping a future where healthcare solutions are not just innovative but also have a lasting impact on patient care and industry excellence. |
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Production, import, or sale of medical devices that are exempt according to Section 27
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Submitting an application to manufacture, import, or sell medical devices that are exempt according to Section 27 is a channel for accessing medical devices that are needed to diagnose, treat, cure diseases or abnormal conditions of the body or for research, analysis, quality standards, and safety of medical devices.
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New Australian Clinical Trials website |
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The Australian Government Department of Health has just launched an upgraded and refreshed Australian Clinical Trials website. It provides an easier way to find and understand information about clinical trials in Australia. There's a new and improved clinical trial search to help people locate a trial they may want to take part in.
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Australia, Japan and UNICEF ramp up cooperation with Vietnam in health digital transformation. |
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The 2023 International Conference on Digital Health got underway in Hanoi on November 8 as part of efforts to step up cooperation between Vietnam and Australia in health digital transformation. The two-day event provided an opportunity for researchers and experts in the field of digital health and health care to come together to share policies, strategies, initiatives, and experiences in applying digital technologies in the health sector.
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In support of the Government of Vienam’s priority to achieve digital transformation across all its work, the United Nations Children’s Fund (UNICEF) teamed up with the Government of Japan to support the Health Ministry in transforming digital health information for children. On November 7, 22 laptops, 168 desktops, and 20 barcode readers were distributed in Gia Lai province as part of the support from the Government of Japan and UNICEF to strengthen the digital health system in Vietnam.
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The governments of Namibia and China launched the China-Namibia paired hospital cooperation mechanism at Walvis Bay Hospital, in the port town of Walvis Bay, about 395 km from Windhoek, the Namibian capital. The event also marked a medical equipment donation valued at 1.07 million Namibian dollars (about 55,000 U.S. dollars) by the Zhejiang Provincial Hospital of Traditional Chinese Medicine. The donated items include essential medical equipment like ventilators, patient monitors, defibrillation monitors, baby incubators, portable suctions, a telemedicine collaboration platform, and a cloud imaging system.
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The November 2023 Prescribed List of Medical Devices and Human Tissue Products (Prescribed List) has been amended to clarify the condition placed on the billing codes listed in Part A for surgical guides and bio models and to correct the technological, data entry, and editorial errors in the benefits for six billing codes and references to the sections of the Rules. The delegate of the Minister for Health and Aged Care has made the Private Health Insurance (Medical Devices and Human Tissue Products) Amendment Rules (No. 2) 2023 (MDHTP Amendment Rules). The MDHTP Amendment Rules were registered on the Federal Register of Legislation on November 10, 2023, and will commence on November 11, 2023.
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Heart Failure start-up Acorai secures €2.3 million in grant funding from the European Commission. |
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Acorai, a start-up medical device manufacturer from Sweden, announces selection for a €2.3 million grant with a follow-on €10 million investment offer from the European Innovation Council (EIC). Only a handful of companies that apply for the EIC accelerator are successful, and Acorai was among the top applicants who received the maximum funding amount. |
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NYU Langone Health Performs World’s First Whole-Eye & Partial-Face Transplant
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A surgical team from NYU Langone Health performed the world’s first whole-eye and partial-face transplant for a 46-year-old military veteran from Arkansas who survived a work-related high-voltage electrical accident. The surgery included transplanting the entire left eye and a portion of the face from a single donor, making this the first-ever human whole-eye transplant in medical history and the only successful combined transplant case of its kind.
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Ready for Manufacture Joint Ventures – the dos and don’ts
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Recently, we were approached to consider supporting a joint venture to bring an EU company to Asia. The basis of this joint venture was to utilize the Asian country’s resources and closeness to the Asian market for easier market access.
From a logical point of view, this makes sense. Just that, there are many areas and facets of this to consider. - Maturity of the original manufacturer. It is more about the technical capabilities and the practical experience of the original manufacturer, or else it would be a challenge to do the design transfer and the training for the JV manufacturer.
- Resources of the JV This will be in terms of sufficient investment to bring in the appropriate talent, equipment, factory space, quality systems, and necessary certifications.
- Raw materials and component availability Initially, it may be based on the original manufacturer, but at some point, in time, there will be cost outs or improvements to the raw materials or components.
- Governance: shareholding, governance, and finance are all critical to the success of ensuring necessary transparency and accountability. Trust is overrated.
- Market entry and access capabilities in the region. It is not enough to say "Oh, we will leave it to the distributors" Who are they? What profile are they? Are there some possible candidates already? This search can be really long, or the JV manufacturer can consider bringing in sales and business development.
- Intellectual Property. Often not properly considered. Not all products and technologies are meant to be patented. Some patents need to be built upon.
Therefore, this strategy is key.
Just some of the key ones; there are many more, and Access-2-Healthcare knows how to deal with such venture-building projects. Feel free to contact us.
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The holiday seasons are here, so get packing and visit some of these MedTech events! |
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