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While our Group Executive Director's presenting at the GHWP Leaders' Meeting in Cairo, life goes on for Access-2-Healthcare! With much movements in Healthcare, enjoy our Newsletter!
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EGYPT Egypt issues nearly 20 million digital treatment approvals as health insurance digitalisation accelerates |
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Egypt’s Ministry of Health and Population announced that nearly 20 million electronic treatment approvals were issued in the 2024/2025 fiscal year via the General Authority for Health Insurance, highlighting major progress in healthcare digitalisation. This initiative includes digitising clinics, automating medical warehouses, integrating hospitals into imaging networks, and preparing AI services to boost service quality and operational efficiency nationwide.
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UNITED KINGDOM Unprecedented boost for clinical trials under 10 Year Health Plan |
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The UK government’s 10 Year Health Plan will accelerate clinical trial set-up, integrate trial recruitment into the NHS App, and streamline bureaucracy, aiming to restore the UK’s leadership in medical research and deliver innovative treatments to patients faster. This approach will improve patient access to cutting-edge care, boost participation from diverse groups, and drive economic growth by making the NHS a global hub for clinical research. |
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SINGAPORE ClavystBio and ASTAR Partner to Grow MedTech Ventures in Singapore |
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ClavystBio and Singapore’s Agency for Science, Technology and Research (ASTAR) have signed a two-year Memorandum of Understanding to jointly create and grow MedTech ventures in Singapore, leveraging ASTAR’s MedTech Catapult and Diagnostics Development Hub, as well as ClavystBio’s investment and venture-building expertise. The partnership aims to foster new ventures, advance product development, accelerate commercialization, and strengthen Singapore’s MedTech ecosystem amid rapid sector growth. |
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UNITED STATES
Thermo Fisher plans to sell parts of diagnostics unit for $4 billion, FT reports |
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Thermo Fisher Scientific, a U.S.-based company, is planning to sell its diagnostics unit—including its microbiology business—for about $4 billion to shed low-growth assets, though there is no guarantee a sale will occur. In February, Thermo Fisher acquired Solventum's purification and filtration business for approximately $4.1 billion in cash. |
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AUSTRALIA
Unique Device Identification (UDI) launch workshop |
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On June 13, 2025, the TGA announced an expression of interest for UDI launch workshops to support sponsors' understanding of and compliance with the new UDI regulations. This follows the official launch of Australia's UDI system on May 29, 2025. To sign up for the workshop, click here. |
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MALAYSIA Announcement: Implementation of medical device import permit |
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The Malaysian Medical Device Authority (MDA) now requires importers to apply for medical device import permits via the online ePermit system at least 7 days before shipment, with standard processing in 3 days and expedited options for urgent cases; a 9-month waiver of the RM130 permit fee is available, but registration and annual subscription fees still apply. Hands-on ePermit training sessions are scheduled through August 2025. To sign up for the first hands-on training ePermit session, click here. |
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UNITED KINGDOM First major overhaul of medical device regulation comes into force across Great Britain |
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New Post-Market Surveillance (PMS) regulations in Great Britain require medical device manufacturers to actively monitor the safety and performance of all UKCA- and CE-marked devices, report serious incidents more quickly, and provide comprehensive safety data to the MHRA to enable faster responses and earlier detection of risks. These reforms set stricter requirements for data collection, incident reporting, and risk communication, aiming to enhance patient safety and support innovation in the UK’s medical device sector.
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REGULATORY APPROVALS
Regulatory
Device Classification – a bit of intended use/purpose magic goes a long way.
Recall our now-(in)famous “intended use algorithm”
“ the (what)1 product is a (what)2 , that (does what to whom)3 to (achieve what)4 in a (what setting/environment)5. It is not (what)6 ”
Where is the magic? Show me the magic!
It is at ‘achieve what’ – why?
This is because it is the output – which also impacts the risk the device may pose – ultimately determines together with its mechanism of action (does what to whom), that would determine the device classification, and sometimes this classification may be different for the same intended use/purpose.
For example, a very thin line separates a software-as-a-medical device (SaMD) that says “monitoring” as opposed to “indication”. If you are “monitoring” it depends what condition are you monitoring (e.g. monitoring rapid-eye movement is very different from monitoring cardiac output). Or “diagnosis” (determination of a clinical condition) vs “assessment” (perhaps you need to head to the doctor, or you are going good). Or therapy (pain minimisation/relief vs elimination of pain). Some may result in determining if it is a medical device or not!
With different device classification, different regulatory and more importantly, clinical strategy may apply. While design verification and validation activities remains the same irrespective of device class, the rigor of these activities (sample sizes and extent of such studies) would correspondingly change with different device classifications.
Therefore much time is taken to script and scrutinise the intended use/purpose as the fundamental piece of information that would determine the amount of resources and effort expected of an organisation to invest.
Need a clearer path to device classification?
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EU health technology assessment: Advent of a new era of collaboration
Brussels, Belgium
2 July 2025 More info ⟶ |
16th Medical Device Development Expo Tokyo
Makuhari Messe in Chiba, Japan 9 - 11 July 2025 More info ⟶ |
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World Health Expo (WHX & WHX Labs) Kuala Lumpur 2025
MITEC, Malaysia 16 - 18 July, 2025
More info ⟶ |
Vietnam Medi-Pharm Expo 2025
SECC, Ho Chi Minh City, Vietnam 31 July - 2 August 2025
More info ⟶ |
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