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May is shaping up to be an active month across the global medtech landscape. Regulators are moving with purpose — the UK’s MHRA has opened the floor for feedback on sweeping new pre-market device requirements, Malaysia is tightening oversight of aesthetic medical devices, and the FDA is upgrading its post-market surveillance infrastructure with enhancements to its eMDR system. India is quietly making history as one of the first countries in the Global South to develop a health AI benchmarking platform. The MedTech “event season” picks up in June, with gatherings from Boston to Berlin to Singapore. Access-2-Healthcare is across all of it — here is your May briefing.
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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY? |
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Vietnam promotes healthcare innovation through Resolution 57
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On April 22, the Ministry of Health (MOH) held a high-level meeting to further accelerate the implementation of Resolution No. 57 within the healthcare sector. According to Minister of Health Dao Hong Lan, the past year has seen transformative shifts. Under the Prime Minister’s Decision No. 1131/QD-TTG, the Ministry has been tasked with—and is decisively implementing—11 strategic technologies. Notable among these is the Advanced Biomedical Technology group, which includes next-generation vaccines, gene therapy (gene editing), and cell therapy (stem cells and immune cells)
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Budget 2026-27: A stronger care system for all Australians
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The Albanese Government is continuing to deliver a stronger Medicare to ensure Australians can get the care they need, when and where they need it.
The 2026-27 Budget builds on the first term of government and delivers significant investments and critical reforms to secure the future of the universal health and disability support system — Medicare, the Pharmaceutical Benefits Scheme (PBS), aged care and the National Disability Insurance Scheme (NDIS). |
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ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE |
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Viet Nam and India exchange cooperation documents in science, technology and innovation
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Within the framework of the Viet Nam–India Innovation Forum, General Secretary and President To Lam witnessed the exchange of cooperation documents between agencies, institutions, and enterprises from both countries in science, technology, innovation, and digital transformation. Participating organisations included Viet Nam National University Ho Chi Minh City, the Indian Institute of Technology Roorkee, the Posts and Telecommunications Institute of Technology of Viet Nam, the Indian Institute of Technology Madras, VINASA, NASSCOM, VNPT, and HCL Technologies. The collaboration aims to strengthen workforce development, joint research, technology transfer, and innovation ecosystem connectivity between Viet Nam and India, with growing focus on AI, digital transformation, and emerging technologies.
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India among first in the Global South to develop health AI benchmarking platform
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The Ministry of Health and Family Welfare (MoHFW), in collaboration with the National Health Authority (NHA), IndiaAI Mission, and the Indian Institute of Science (IISc), Bengaluru, today inaugurated the AB PM-JAY Auto-Adjudication Hackathon Showcase 2026, marking the commencement of a two-day national event focused on leveraging artificial intelligence (AI) to strengthen health claims management under Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY). The inaugural day brought together policymakers, technology innovators, insurers, Third Party Administrators (TPAs), healthcare providers, academia, and AI startups to deliberate and demonstrate cutting-edge AI-enabled solutions aimed at enhancing efficiency, transparency, and integrity in claims adjudication.
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MHRA invites views on proposed changes to medical device regulation
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New pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) on the World Trade Organisation notification portal on Friday 8th May 2026. The notification provides an opportunity for WTO members to comment on the draft pre-market regulatory requirements, titled the draft Medical Devices (Amendment) Regulations 2026.
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FDA announces enhancements to the electronic Medical Device Reporting (eMDR) system
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The U.S. Food and Drug Administration (FDA) announced enhancements to its electronic Medical Device Reporting (eMDR) system aimed at improving reporting efficiency, system functionality, and post-market surveillance processes for medical device manufacturers. The updates support more streamlined submission and management of adverse event reports while strengthening regulatory oversight and traceability of medical devices in the U.S. market.
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FDA commissioner resigns after tumultuous tenure
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Dr. Marty Makary resigned as commissioner of the Food and Drug Administration on Tuesday, ending a 13-month tenure marked by turmoil. President Trump spoke at the White House about the FDA leadership change as he was preparing to leave on a trip to meet China's President Xi Jinping. His departure caps a tumultuous run at the helm of an agency that regulates medical treatments, vaccines and much of the U.S. food supply. |
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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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FINDING DISTRIBUTION CHANNELS Legal Entities
Previously in earlier issues, we had explained about pros/cons of distributors, have explained about how to search for a shortlist without spending much, about which categories of devices may do better with or without a distributor. What else is left?
Legal entities.
Woah, this is a huge investment! Yes, it is, but not just from the monetary sense, but from the amount of time, effort, and human resource management.
But sometimes – this is the way to go.
Some possibilities - large capital medical equipment. Yes a distributor may help but with capital equipment, this investment includes having trained service staff, and enough space to store modules. - software as a device. Really? Sometimes there may be dedicated backup, and for some reason they feel uncomfortable placing in a data center. - for a broader purpose of being a sales/service hub. Acts as a control center for other countries
With a legal entity – some of the typical considerations include shareholding, directorship, type of office address, location, allocated space. For the medical device industry, there are other considerations such as good distribution practices or importer licenses, and responsible personnel, not just to run the show, but to be legally responsible.
While it does comes down to dollars and sense (as in logic), sometimes some dollars and wasted time can be saved if one has planned the strategy well
We have legal entities alright – 14 of them. Let us know if you’re keen to learn how we do it besides hard work, perseverance, and a bit of good fortune!
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The Asia Summit on Global Health (ASGH) 2026 and the HKTDC Medical and Healthcare Fair were held in May 2026 at the Hong Kong Convention and Exhibition Centre (HKCEC). The events brought together global policymakers, industry leaders, investors, and healthcare innovators to exchange insights on emerging trends in global health, medtech innovation, and cross-border collaboration opportunities. Over the course of the programme, participants engaged in high-level discussions, business matching sessions, and exhibition showcases featuring cutting-edge medical technologies and digital health solutions.
For more information, visit our blog for some of the event highlights and key activities!
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MedTech Gatherings happening in June 2026! |
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MedTech Summit 2026 Berlin, Germany Jun 15–18, 2026
More info ⟶ |
Medtech MVP Venture & Partnering Conference The Royal Sonesta Minneapolis Downtown, USA Jun 1–2, 2026
More info ⟶ |
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26th International MedTech Safety Conference Northeastern University, USA
Jun 2–5, 2026
More info ⟶ |
LSI Asia ‘26
Shangri-La Orchard Road, Singapore 30 June- 2 July 2026
More info ⟶ |
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