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This month's Newsletter wraps up the year and here we just met the first snowfall in Beijing. The Year 2025 highlighted a series of collaborations, including Access-2-Healthcare’s strategic partnerships with our key clients, for our mutual success. While there may be various versions of how this year had turned out, we would say it is a year for the revenue makers - whether you do or do not, determines your success. What a standout year for Access-2-Healthcare and the MedTech industry!
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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY? |
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Singapore unveils S$37 billion RIE2030 Plan to advance research and innovation, and support Singapore’s economic and national priorities |
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Singapore will invest S$37 billion (US$28.5 billion) – or about 1 per cent of its economic output – on research, innovation and enterprise over the next five years, announced the National Research Foundation (NRF) on Friday (Dec 5). Of the total sum, 8 per cent – or S$3 billion – will go towards research, innovation and enterprise in flagships and “grand challenges”, including the semiconductor industry and longevity research. |
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New qualifications in MedTech to tackle 145,000 skills shortage and ease NHS pressures. |
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New Higher Technical Qualifications (HTQs) have been developed in order to boost skills in the fast-growing medical technology sector. The program aims to train thousands of technicians and regulatory advisers to handle AI-enabled devices, imaging and diagnostic tools, and wearable technology. Training will be provided through educational institutions, the private sector, and universities. |
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ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE |
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Medical device maker Teleflex to divest three units for $2.03 billion |
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Medical device company Teleflex announced it will sell three business units for $2.03 billion as part of a strategy to focus on its core critical care and hospital segments. The company will divest its Acute Care and Interventional Urology units to Intersurgical, and its OEM division to private equity firms Montagu and Kohlberg.
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Philips agrees to acquire SpectraWAVE Inc. |
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Philips has signed a deal to acquire SpectraWAVE, Inc., an innovator in Enhanced Vascular Imaging (EVI) of coronary arteries, angiography-based physiology assessments, and the use of AI in medical imaging. The acquisition strengthens the Dutch medtech giant’s minimally invasive percutaneous coronary intervention (PCI) toolkit for coronary artery disease (CAD) treatment and assessment.
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Temasek-backed D3 Bio secures $108M in Series B financing to advance global clinical programs |
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D3 Bio, a global clinical-stage biotechnology company focused on the discovery and development of innovative oncology therapeutics, has announced the completion of a $108 million Series B financing round. The funding round was backed by a distinguished group of investors, including IDG Capital and SongQing Capital.
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Industry raises concerns over approval of refurbished medical device imports |
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The recent approvals granted for the import of refurbished and reconditioned medical devices raise serious concerns for India’s healthcare ecosystem. These moves risk undermining the “Make in India” vision, despite a clear CDSCO ban and ongoing court proceedings, and may create an uneven playing field for domestic innovators who have invested heavily in indigenous R&D and manufacturing.
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FDA Launches TEMPO: A first-of-its-kind digital health pilot
to expand access to chronic disease technologies |
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The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. This voluntary program, developed by the FDA’s Center for Devices and Radiological Health (CDRH), will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. |
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UNITED KINGDOM & SINGAPORE |
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UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough health technologies |
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UK and Singapore health regulators have launched a cross-border Regulatory Innovation Corridor to help bring breakthrough medicines, medical technologies, and advanced diagnostics to patients faster—while maintaining safety standards. Announced on 12 December, the initiative connects the UK’s MHRA and Singapore’s HSA, with Flagship Pioneering named as the first industry partner. |
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MDCG has released "2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746" |
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The Medical Device Coordination Group (MDCG) has released "2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746" to provide a framework for breakthrough medical devices, with a pilot rollout expected in the second quarter of 2026. This initiative aims to streamline the integration and regulation of cutting-edge medical technologies within the European medical device regulatory environment.
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The Indian Government unveils PRIP Scheme to transform Pharma and MedTech sectors |
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The Government of India has launched PRIP (Promotion of Research and Innovation in the Pharma-MedTech Sector), a ₹5,000 crore initiative to transform the industry from cost-driven manufacturing to innovation-led growth. As part of the program, seven Centres of Excellence have been established across NIPER campuses to strengthen national research and innovation capacity. |
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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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QUALITY MANAGEMENT SYSTEM Every once in a while, a gun has to be fired. Or not fired. It hard to tell when you are not in the field.
There have been a variety of eQMS, eTF and all sorts of such, then it went to risk management, AI-enabled content population and the likes. It really does help to craft a ready-to-use QMS, and satisfies management, auditors, regulators alike. Even the training and competency stuff came along beyond just classroom training as AI had devised ways to assess competency via games, puzzles, quizzes, situational analyses etc.
Except one thing – it’s not reflecting the actual processes.
Remember “do as you say, say as you do”? Now it becomes “I tell AI what to say, and I just put it there, and do what I want”
A QMS is meant to provide a set of interconnected processes and procedures documented in such a way to help a new colleague come on board more quickly, or to provide guidance to a conflict. Yes, we have requirements but we appear to forget why we are doing this.
For example if regulations says to launch in country X thou shalt comply with cybersecurity requirements, and somehow did not specify the need to have vulnerability and penentration tests independently assessed. What happened to the design and development and risk management processes to determine the need to do this independently, regardless of what regulations say? It is to do the right thing and our QMS helps us with this.
Not to say AI isn’t usable, but far more thought needs to go into it and most important of all, its reflecting what people are actually doing, and doing it correctly.
Let's go beyond your checkbox compliance! |
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Vietnam Medi-Pharm 2025
Vietnam Medi-Pharm Expo 2025 marked a strong return this October, reaffirming its position as Vietnam’s leading healthcare and pharmaceutical exhibition. Under the theme “Active integration – Non-stop contributions to Vietnam's health sector,” the event brought together Vietnamese and international companies to showcase advanced medical technologies, products, and healthcare solutions.
Explore some event highlights! |
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Malaysia Strengthens Regional Leadership in Medical Device Regulation |
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The Chief Executive of the Medical Device Authority (MDA) has been appointed Chairman of the Global Harmonization Working Party (GHWP), underscoring Malaysia’s growing influence in shaping international regulatory harmonization and collaboration. |
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The MDA of Malaysia and the Thai Food and Drug Administration (Thai FDA) have signed a Confidentiality Agreement and launched a three-month Medical Device Regulatory Reliance Programme (1 February–30 April 2026). The pilot aims at streamlining the registration of Class B, C, and D medical devices. |
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MedTech Gatherings happening in January 2026! |
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J.P. Morgan Healthcare Conference 2026 San Francisco, California, United States
January 12 - 15, 2026
More info ⟶ |
Global Conference on Pharma Industry & Medical Devices 2026
Changwon, South Korea
January 28 - 29, 2026
More info ⟶ |
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ICT&health World Conference 2026
MECC, Maastricht, Netherlands
January 27 - 29, 2026
More info ⟶ |
IMCAS World Congress 2026
Palais des Congrès de Paris, Paris
January 29 - 31, 2026
More info ⟶ |
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