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“Tariffs”. Is this the only word everyone’s thinking about?

How about “MedTech”?

As unpredictable as the recent weather patterns, and economic dynamics, it does impact how #Healthcare and thus #MedTech is funded publicly and privately. For this issue, Access-2-Healthcare have curated a geographically distributed set of news around the world, to keep you informed correctly and up to date.

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INDIA

Provision for autogenerated Market Standing Certificate and Non Conviction certificate

for license medical device

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To promote ease of doing business, the online application process for Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC) for centrally licensed medical devices has been upgraded. The new system now auto-generates these certificates. All pending MSC/NCC applications in the old workflow will be automatically rejected. Stakeholders must re-submit fresh applications from the date of this notice.

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SOUTH AFRICA

ISO 13485 Certificate as a prerequisite for the approval of a Medical Device Establishment Licence

SAHPRA has mandated that all medical device license holders under Section 22C of the Medicines Act must possess ISO 13485:2016 certification, with phased verification starting June 1, 2025, and full compliance required by April 1, 2028. Renewal applications will now require valid ISO 13485:2016 certificates from SAHPRA-recognized certification bodies, while existing license holders must submit proof upon request or during amendments.

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Regulation (EU) 2017/745 on medical devices (MDR):

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

UK approved bodies:

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FRANCE

French hospital staff and relatives sue ministers over work-related suicides

Nineteen plaintiffs have filed a complaint accusing French Health Minister Catherine Vautrin, Higher Education Minister Elisabeth Borne, and Junior Health Minister Yannick Neuder of enabling "illegal and deadly working conditions" in public hospitals, citing cases of workplace harassment and suicides linked to overwork and coercive management.

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AUSTRALIA

Applications are open for SBE Australia's 2025 Life Sciences program

SBE Australia seeks to support high -potential women entrepreneurs in Australia. Their 2025 Life Sciences program supports women-led life sciences companies with a proven MVP and clinical trial progress by providing business knowledge, growth capital, and expert mentorship to scale globally.

Backed by a strong advisory network, it helps founders define growth goals and capital needs—while remaining non-dilutive to preserve equity. Applications close on 28th April 2025 and the programme commenced on 26th May 2025.

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UNITED KINGDOM

UK medical devices group Niox halts sale after Keensight backs out

Niox Group (NIOX.L) has halted its sale process after Keensight Capital withdrew its £345.8 million buyout offer due to challenging macroeconomic conditions, despite initially proposing an improved bid of 81 pence per share. The UK-based medical device maker had considered recommending Keensight's offer but has backed out of the investment deal, now facing broader economic risks, including trade war disruptions and recession fears highlighted by the Bank of England.

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CHINA

Vicarious Surgical Receives Continued Listing Standard Notice from the NYSE

United Imaging Healthcare and IHH Healthcare have signed a collaboration agreement to broaden global access to advanced medical imaging technologies while raising the bar for excellence in precision diagnostics. After visiting United Imaging Healthcare’s booth, Mr. Aaric Niew, Group Procurement VP at IHH Healthcare praised the company's advanced manufacturing and technical refinement, noting opportunities to integrate software and AI for clinically relevant solutions.

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PROCESS FLOW

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READY FOR MANUFACTURING

Tariffs increasing costs of manufacturing? Definitely!

It is not about one country setting tariffs or many countries, because ultimately it is the end-user that ends up paying for these increases

Making in your home country? Never. The almost-funny analogy was during my Japan trip where we asked a typical yakitori – whether there will be cost increases, either from foreign exchange or from tariffs. “sure, where do you think the stick of the yakitori come from?”

Supply chains have been globalised since hundreds of years ago, therefore at some point these tariffs will eventually affect the final cost of the medical device “But there’s no tariff on medical devices, we are asking for exemption!” sure thing, even if the exemptions are approved and in place, what about the materials and components used for the medical device?

We are never ready for such dynamic economic and political changes. It will still make sense for the final manufacturing to be tightly controlled, and same with the critical suppliers. To hold prices more or less stable, being more efficient, and take significant measures to reduce cost (perhaps even more outsourcing!), and most importantly – just perhaps – some government support to offset the prices of medical devices would do so much to the patients and end-users.

For any design for manufacturing,

design transfer, or factory setup

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APACMed & KPMG Investor Readiness Workshop

The Workshop is designed to equip MedTech startups with the insights and practical knowledge needed to successfully engage with investors. Raising capital is one of the biggest challenges for startups, especially in the early stages. This session will provide a deep dive into key investor expectations, tax and legal considerations, common red flags, and strategies to craft a compelling pitch that stands out in a competitive market.

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