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July’s been a whirlwind (just see how many countries have typhoons looming at the moment!) — and for us, it also marks the launch of our new Hong Kong office! If the Greater Bay Area is your next destination, Access-2-Healthcare is ready when you are.
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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?
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WHO unveils AI roadmap for traditional meds
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The World Health Organization (WHO) has released its first-ever roadmap for applying Artificial Intelligence (AI) in traditional medicine, following India’s proposal. Titled "Mapping the Application of AI in Traditional Medicine," the document highlights India’s efforts like the Traditional Knowledge Digital Library (TKDL), Ayurgenomics, and digitized practices in Ayurveda and Yoga.
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EU and China Escalate Trade Restrictions
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The EU has barred Chinese medical companies from bidding on EU public tenders over €5 million to ensure reciprocity in procurement access. In response, China imposed a ban on EU-origin medical devices in government procurement over ¥45 million (~$6.3 million) and limited EU-sourced medical content in third-party bids—covering contracts for non-EU firms.
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ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE
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MIT develops implantable device to automatically release emergency glucagon
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MIT engineers have created an implantable device that automatically releases emergency glucagon when blood sugar drops too low—providing vital protection for people with Type 1 diabetes, especially during sleep or when unable to self-administer injections. The device may also deliver emergency epinephrine in critical situations. Published in Nature Biomedical Engineering, the research marks a major advancement in automated emergency response for chronic conditions.
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$100 million to support Australian medical innovations
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The Albanese Government has committed nearly $100 million to support emerging Australian biomedical and medical technology innovations. Funding was awarded to Brandon BioCatalyst, ANDHealth Pty Ltd, and Bionitelect Pty Ltd, which will serve as incubators to help SMEs commercialise new medical products. This initiative, under the Medical Research Future Fund, is expected to provide $450 million over 10 years to boost Australia’s MedTech sector.
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HSA publishes revised GN-09 Guidance and upgraded MEDICS to SHARE
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Revision 4 of GN-09 Guidance on the Component Elements of a Dear Healthcare Professional Letter and 4 of GN-10 Guidance on Medical Device Field Safety Corrective Action, are finalised and these guidances can be accessed from HSA Guidance documents at the below medical devices webpage. As of 14th July, HSA MEDICS has been upgraded to SHARE (Singapore Health Product Access and Regulatory E-System).
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Hong Kong Centre for Medical Products Regulation to be established by the end of 2026
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The Hong Kong Department of Health has announced its plan to establish the Centre for Medical Products Regulation (CMPR) by the end of 2026. Legislative proposals are expected within the coming year, reflecting the government’s commitment to strengthening its regulatory framework and advancing independence in the oversight of medical products.
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India's CDSCO releases Addendum 02 to FAQs on Medical Devices
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The Central Drugs Standard Control Organization (CDSCO) has issued Addendum 02 to its Frequently Asked Questions (FAQs) on medical devices (Doc No.: CDSCO/FAQ/MD/01/2024). Released on 9 July 2025, this update offers clearer guidance on licensing, importation, classification, and other regulatory requirements under India’s Medical Device Rules.
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Latest list of Designated Notified Bodies
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PRODUCT COMMERCIALISATION
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Articles to help your journey in commercialisation
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FINDING DISTRIBUTION CHANNELS Establishing channels – can you commit?
It's tempting to think, “Let’s just hand it off to a distributor who knows the market.” And in the early stages, that may seem like the right call—experienced distributors often have deeper networks, stronger doctor relationships, and local knowledge.
But how do you know which distributor is the right one? Sure, reputation, doctor networks, and familiarity with your clinical segment are important. But the most critical factor? Commitment.
Commitment means having a commitment to continue to propagate whatever the manufacturer had propagated, either through sales, through clinical education within the market. Commitment means having customer support after sales, to maintain the customer relationship. Commitment means not just knowing the clinical workflow, but studying intently to see how this workflow can improve outcomes.
Commitment also happens on the other end – the manufacturer. Commitment to initially seed the investment through a go-to-market strategy instead of just relying on distributors. Commitment through providing product knowledge, training, sharing the successes and learning the failures of other markets and partners. Commitment through venturing together and not just relying on the distributor to ‘pay for it all as a sign of commitment’.
Distributors remain the most common route to market. But success lies in mutual commitment, trust, and ongoing collaboration—not just contracts.
Ready to build a committed channel strategy that scales with your growth?
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Access-2-Healthcare at Japan Health 2025!
Held in June 2025 at INTEX Osaka, Japan Health 2025 marked the launch of a brand-new international trade show dedicated to the medical and healthcare industries. The event brought together medical device manufacturers, startups, research institutions, and public agencies from Japan and beyond to showcase cutting-edge technologies and healthcare services. Officially part of EXPO 2025 Osaka, Kansai – Health & Wellbeing Week, the exhibition gained global attention as a key event during the Expo. We were so excited to be a part of this event — read more about our blog post!
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Key MedTech Events to Catch in July!
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AHRMM25 Annual Conference Denver, Colorado, USA
August 3-6, 2025
More info ⟶
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The International Forum on Quality and Safety in Healthcare
Brussels, Belgium August 13-15, 2025
More info ⟶
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RISE West 2025
Paris Las Vegas, Las Vegas, NV, USA
August 25–27, 2025
More info ⟶
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AMEE 2025
Barcelona, Spain
August 23-27, 2025
More info ⟶
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Asia Patient Experience and Healthtech Summit Bali 2025
Bali, Indonesia
August 28-29, 2025
More info ⟶
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