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This month’s spotlight is on Medical Fair Asia — The region’s biggest stage for MedTech innovation. Access-2-Healthcare was excited to be part of the action, connecting with forward-thinking companies and exploring the latest solutions shaping healthcare. Alongside our experience at the fair, we’ve rounded up some of the most exciting MedTech news and updates from across the industry this month.
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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY? |
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Indonesia prepares incentives to boost the medical device industry |
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The Indonesian government is preparing incentives to strengthen its domestic medical device industry, including tax breaks and easier access to financing. The ministry is also pushing for product standardization so local devices can compete globally. Producers are being assisted in meeting international standards such as ISO 13485, IEC 60601, and US FDA requirements. |
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Vietnam’s health sector strengthens ties with South Korea in medical technology and equipment |
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Vietnam is aiming to enhance collaboration with South Korea in the health sector, focusing on research, training, technology transfer, and the production and supply of medical equipment. Nguyễn Minh Lợi, Director General of the Department of Medical Infrastructure and Equipment, emphasized the importance of building strong channels for partnership to advance Vietnam’s medical technology capabilities. |
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ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE |
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Mainland's medical-device maker Mindray picks Huatai, JPMorgan for HKSAR listing |
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Shenzhen-based Mindray Bio-Medical Electronics, one of China’s largest medical device manufacturers, has appointed Huatai and JPMorgan to manage its planned listing in the Hong Kong Special Administrative Region (HKSAR). The company is expected to raise at least $1 billion, according to Bloomberg News. The listing marks a significant step in Mindray’s international expansion and access to global capital markets. |
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TVM Capital Healthcare closes first USD 150M Southeast Asia Fund |
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TVM Capital Healthcare has announced the first closing of its USD 150 million Southeast Asia Fund, the third generation of its healthcare investment funds. Building on nearly 40 years of global healthcare investment experience and over 15 years scaling healthcare companies in the Middle East and SEA, the fund aims to support innovative care models, specialty care providers, and solutions that expand access and improve healthcare quality outside traditional hospital settings. |
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Separate provision for subsequent Importer in Online system for Medical Devices |
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The Central Drugs Standard Control Organization (CDSCO) has introduced a new feature on its online portal, effective 11 September 2025. The provision allows “Subsequent Importers” to apply for the import of medical devices and in-vitro diagnostics (IVDs) that have already been approved by the Central Licensing Authority under the Medical Devices Rules, 2017. Access is available via the CDSCO online system (cdscomdonline.gov.in) |
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Updated Manual on Borderline and Classification under MDR & IVDR |
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The European Commission has published the latest edition of the “Manual on Borderline and Classification” under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). This updated manual provides guidance to manufacturers, notified bodies, and regulators on determining whether a product qualifies as a medical device or in-vitro diagnostic device, or falls into a borderline category.
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Bilateral discussion on Medical Device Regulatory Reliance Programme |
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The Medical Device Authority (MDA) of Malaysia and CDSCO India have agreed to initiate the bilateral discussion on a potential Medical Device Regulatory Reliance Programme. The programme aims to recognize each other’s pre-market approvals, reducing duplication and expediting access to medical devices. Authorities from both countries are working closely and expecting to launch a pilot for the Reliance Programme soon. |
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NMPA issues Guidelines for Self-Inspection and Verification of Medical Device Registration |
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The General Office of China’s National Medical Products Administration (NMPA) has issued the “Guidelines for Self-Inspection and Verification of Medical Device Registration”. The guidelines aim to strengthen registration management, standardize self-inspection practices for registration applicants, and ensure orderly implementation of medical device registration self-inspections, including in vitro diagnostic reagents. The guidelines are based on the Medical Device Supervision and Administration Regulations (State Council Order No. 739) and supporting regulations and are effective from the date of promulgation. |
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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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INNOVATION Incremental vs transformational
The standard ISO 56000:2020 defines innovation as "a
new or changed entity, realizing or redistributing value". Often times many terms are being thrown around and at the end of the day it is distilled
into two categories – incremental innovation and transformational innovation.
Incremental innovation usually refers, in simple words,
something that is perhaps faster, better and/or cheaper (‘redistributing value’) it does not mean it is a small step change, for example, a better form factor,
or one small feature. .. it can mean it is a big step change such as new features to enhance the core purpose, something that does it much more, or much faster. But the but entity i.e. the method of
realising the value i.e. the intended purpose did not change. Such innovation can move at a faster pace,
because of the presence of predicates, examples, and more travelled pathways.
Transformational innovation, would refer to a new entity, or
a new way to realise value. Some method
that has not been used in this way before, or causing a totally new clinical workflow. Note that a new method to fulfil the same
intended purpose is still ‘incremental’ but taking a regular CRM tool and re-purposing it based on some added features, to create an end to end platform from
lead to cash may be transformational.
Transformational innovation takes more time, as it is a new
way or new thing, in which clinical studies, and evidence, planning, validation will be definitely required.
In our MedTech world, it is getting more challenging to come
up with transformational innovations – partly because we had already done a fantastic job managing healthcare as far as possible in terms of advancing technology, but once in a while, something
transformational may come along, and it would always go against the grain, fraught with challenges, and doubtful eyes. With a bit of perseverance, humility and
open-mindedness, it makes Healthcare much better
Innovation starts with action |
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Despite the traffic typical of Thailand, attending Medical Fair Asia was a rewarding experience. The event was well-organized, creating an excellent platform for discovering new technologies and forging connections.
We had the chance to engage with innovative companies offering advanced solutions, including:
KOBE BIOMEDICAL INNOVATION CLUSTER (KBIC) also gave us a warm welcome at their booth, and we had the opportunity to connect with several promising companies under their support. Medical Fair Asia once again highlighted the region’s dynamic role in driving innovation, collaboration, and growth in MedTech. Explore some highlights of the event!
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MedTech Gatherings happening this October! |
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Medical Japan Tokyo – Medical/ Elderly Care/ Pharmacy Week Tokyo, Japan
October 1 – 3, 2025
More info ⟶ |
The MedTech Conference
San Diego, United States
October 5 – 8, 2025
More info ⟶ |
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MedTech Innovator Asia Pacific 2025 Showcase & Grand Finals
Singapore
October 28, 2025
More info ⟶ |
World Health Summit 2025
Berlin, Germany October 12 – 14, 2025
More info ⟶ |
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