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“Rain, rain, go away. Come again another day”. But rain keeps turning up another day! In Black Storms, in typhoons, or just plain and simple heavy rain. The funny thing is that we’ve gone through all during the past month, and perhaps it is a sign of prosperity? Access-2-Healthcare brings you this rainy issue of our MedTech Gateway Newsletter.
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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY? |
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HSA signs MOU with Hong Kong Department of Health to enhance healthcare regulatory cooperation |
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Singapore's Health Sciences Authority (HSA) and the Department of Health (DoH), Hong Kong Special Administrative Region (HKSAR), signed a Memorandum of Understanding (MOU) for cooperation in healthcare regulatory matters about health products on 13 August 2025. This MOU marks an important milestone in strengthening ties between the two regulatory authorities, encompassing technical cooperation and mutual exchange of information |
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China GBA Updates: Advancing integration of Hong Kong medical products in Mainland China |
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Greater Bay Area (GBA) reimbursement frameworks have progressed to support the GBA Connect Scheme, with six mainland cities—Guangzhou, Shenzhen, Zhuhai, Dongguan, Zhongshan, and Jiangmen—each adapting its own policies. Since the Guangdong regulations took effect on December 1, 2024, the Guangdong MPA has approved 116 medical products as of July 21, 2025, benefiting over 10,000 patients.
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Medical Equipment Business Dialogue Conference 2025 |
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On August 15, 2025, the Ministry of Health, together with relevant agencies, hosted the Medical Device Business Dialogue Conference 2025 in Khanh Hoa province. The conference addressed industry concerns such as medical device classification, competition from low-cost imports, and challenges in product registration and circulation. Around 250 representatives from medical device companies nationwide attended the conference. |
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ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE |
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Estonian MedTech startup Better Medicine raises €1 million to expand AI model for kidney cancer detection |
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Tartu-based Better Medicine, a startup developing AI-powered diagnostic tools for radiology, has raised €1 million in a pre-Seed funding round to expand in Europe, prepare for U.S. entry, and pursue clinical and insurance partnerships. With these additional grants, Better Medicine has now secured €2.25 million in private funding and €3.7 million in total grants, bringing its overall funding to nearly €6 million. |
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UnitedHealth closes $3.3B Amedisys buy after long regulatory battle |
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UnitedHealth Group completed its $3.3 billion purchase of Baton Rouge-based Amedisys, more than two years after plans to join the nation's two largest home health and hospice care companies were first announced. The closure of the deal was announced in a filing with the U.S. Securities and Exchange Commission, issued before the markets opened. |
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Heart devices pace medtech’s summer funding flows
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A wave of private investments underscores growing confidence in cardiac innovation. July and August have brought a steady beat of private financings for young medtech companies, with several deals supporting new technologies to treat heart conditions. The market data research firm counted 11 rounds worth at least $100 million each, and $4.1 billion in total venture capital funding in the first quarter alone. |
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MHRA issues Statement of Policy Intent regarding Early Access to innovative medical devices |
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The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”). Although this statement is non-binding, it indicates further efforts by the MHRA to reduce unwarranted barriers to market entry through faster, risk-proportionate, and predictable routes to regulatory approval. |
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China and Malaysia start a reciprocal medical device reliance pilot program |
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Regulatory agencies in China and Malaysia have initiated a pilot program that will provide companies based in each country with accelerated pathways to market for medical devices. The reciprocal agreement has two components. China-based manufacturers of certain medical devices can use Malaysia's verification pathway, and Malaysia-based manufacturers of certain medical devices can use China’s green channel. A pilot assessment of the regulatory reliance program started on 30 July and will run through 30 September.
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Guidance on Systems and Procedure Packs and new UDI Devices module |
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Swissmedic’s August 2025 update brings Switzerland’s systems and procedure pack (SPP) rules in line with EU MDR/IVDR, tightening requirements for registration, labelling, and vigilance reporting. Assemblers now have just three months to register with Swissmedic, and can expect random inspections to verify compliance. Refer to the Swissmedic – Systems and Procedure Packs Information Sheet here The new UDI Devices module in swissdamed is also live. It can be used to register medical devices, in vitro diagnostic medical devices, systems and procedure packs. Refer to the new UDI Devices module here
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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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PRODUCT REACHED CUSTOMERS “I want the Truth!” “You can’t handle the Truth!” If you have your own medical reports, be it a blood test, a neurology test report, a vital signs printout, a digital image, or an AI-generated report based out of all of the above, what do you do with it?
That’s why the manufacturers have to put out the ‘intended use’ or ‘intended purpose’ – what is this device meant to do for you.
At the same time, why we use our teeth to tear open Twisties packets, or use a spoon to pry open a tin can, or use your CPAP machine as a paperweight, is what’s termed as ‘off-label use’. That is, to use the device that the manufacturer does not define.
Is this wrong? Well, not ready. How convenient this answer is! But seriously, during this off-label use: - did the user or patient benefit from it? - did the action cause harm in any way to the user, patient, or the environment around it? - did it compromise some function of the device or its reliability?
While it is easy to say ‘oh you have to use this exactly’ – sometimes it does mean that the device gains another ‘intended purpose’ and therefore allows it to expand another indication.
And while this sounds nice and good, then regulators come in with “did you validate this with a significant population?” and this seemingly beneficial off-label use suddenly fades to the background to be labelled as ‘product complaints’.
Is that the regulators’ fault? No, because an equal and opposite number of parties will claim that this off-label use is the best this next to sliced bread. When it is not or potentially harmful.
Then what do we do? What if the benefits of this off-label use are True?
If there are enough numbers, and if an experiment is done to truly prove its value, then perhaps we can handle the Truth.
Want to turn your off-label potential into a growth advantage? |
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Key MedTech Gatherings in August! |
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WHX Tech
Dubai World Trade Centre, United Arab Emirates
September 8-10, 2025
More info ⟶ |
WONCA World Conference 2025
Lisboa Congress Centre, Lisbon, Portugal
September 17-21, 2025
More info ⟶ |
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Medical Fair Thailand 2025
BITEC Bangkok, Thailand
September 10–12, 2025
More info ⟶ |
Medtec China 2025 Shanghai World Expo Exhibition & Convention Center, China
September 24-26, 2025
More info ⟶ |
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