https://stratus.campaign-image.com/images/147340000028790003_zc_v1_1751534271078_head_banner_(8).png
   

MEDICAL FAIR ASIA 2026 brought the MedTech community together in Singapore — and plenty of conversations along with it. Beyond the trade-show floor, ASEAN is moving towards a single-submission model for medical devices!  Access-2-Healthcare is across all of it — here’s your September edition.

   

In-Country Focus

__________

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

SINGAPORE

Singapore establishes the HSA as an integrated health regulator

Singapore will consolidate healthcare regulatory functions under the Health Sciences Authority (HSA), bringing regulation of healthcare services, health products, health information and biomedical research into a more integrated structure. The first phase will transfer MOH’s regulatory functions and manpower to HSA in November 2026, with professional-board support functions following by end-2027. The restructuring is intended to provide greater regulatory clarity as areas such as digital health, genomics and artificial intelligence increasingly cut across traditional regulatory boundaries.

https://stratus.campaign-image.com/images/147340000028790003_39_1785992762355_zc-noimage.png

VIETNAM

Vietnam expands investigation into medical equipment bribery and smuggling case

Vietnam’s Ministry of Public Security expanded its investigation into alleged bribery, smuggling and accounting violations involving Viet My Medical Investment JSC and related organisations. Authorities prosecuted and detained the Director of Phu Tho Provincial General Hospital and the Vice Chairman of the Phu Tho Provincial People’s Committee, a former provincial health director, over allegations of receiving large bribes. The investigation remains ongoing as authorities examine the wider scope of the case and other parties involved.

https://stratus.campaign-image.com/images/147340000028790003_26_1786025591651_zc-noimage.png
   

Industry Insight

__________

ANNOUCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

CHINA / SOUTHEAST ASIA

Infervision explores deeper AI-healthcare collaboration in Southeast Asia

Chinese medical AI company Infervision discussed opportunities to deepen healthcare technology cooperation in Thailand, including AI-assisted diagnostics and surgical applications, during meetings in Beijing. The discussions also highlighted Malaysia and Indonesia as potential markets for further regional collaboration, reflecting growing interest in expanding AI-enabled healthcare technologies across Southeast Asia.

https://stratus.campaign-image.com/images/147340000028790003_39_1785992762355_zc-noimage.png

ASIA PACIFIC / SINGAPORE

Mitsui and Oncoshot advance Asia–US oncology clinical data collaboration

Japan’s Mitsui & Co. entered a service agreement with Singapore-based Oncoshot to use its AI-powered clinical data technology, drawing on oncology expertise across IHH Healthcare’s regional network. Through Oncoshot’s participation in Memorial Sloan Kettering Cancer Center’s MSK iHub, the collaboration aims to standardise oncology real-world data, support international clinical research and improve access to clinical trial opportunities across Asia-Pacific.

https://stratus.campaign-image.com/images/147340000028790003_33_1786025591655_zc-noimage.png
   

Regulatory Roundup

__________

ANNOUCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

ASEAN / MALAYSIA

ASEAN moves towards single-submission model for medical device approvals

One for all, all for one! ASEAN Member States have agreed in principle to pursue a phased single-submission model for medical device pre-market approvals, with Malaysia expected to serve as the coordinating entry point for technical-document submissions. The initiative aims to reduce duplication across ASEAN markets while individual national regulators retain authority over final registration decisions.

https://stratus.campaign-image.com/images/147340000028790003_39_1785992762355_zc-noimage.png

SOUTH KOREA

MFDS proposes updates to emergency medical device, AI advertising and clinical trial rules

A bunch of updates — South Korea’s Ministry of Food and Drug Safety (MFDS) proposed amendments covering procedures for emergency-introduction medical devices, tighter controls on misleading AI-generated advertisements, device classification pre-reviews, and broader regional participation in clinical trials.

https://stratus.campaign-image.com/images/147340000028790003_26_1786025591651_zc-noimage.png

CHINA

NMPA issues new standard for AI EEG datasets used in brain-computer interface medical devices

China’s National Medical Products Administration (NMPA) issued YY/T 2029—2026, a medical device industry standard establishing quality requirements and evaluation methods for electroencephalography (EEG) datasets used in artificial intelligence algorithms for brain-computer interface medical devices. The announcement confirms that the standard has been formally approved, with its scope and implementation date specified in the accompanying document.

https://stratus.campaign-image.com/images/147340000028790003_39_1785992762355_zc-noimage.png
   
     

Latest list of Designated Notified Bodies

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

  1. 3EC International (Slovakia) – 2265
  2. BSI (Netherlands) – 2797
  3. Bureau Veritas (Italy) – 1370
  4. Berlin Cert Pruf (Germany) - 0633
  5. CE Certiso (Hungary) – 2409
  6. Centro Nacional De Certification (Spain) – 0318
  7. Certiquality S.r.l. – 0546
  8. DEKRA Certification (Germany) – 0124
  9. DEKRA Certification (Netherlands) – 0344
  10. DNV Medcert Gmbh (Germany) - 0482
  11. DNV Product Assurance AS (Norway) – 2460
  12. DQS Medizinprodukte (Germany) – 0297
  13. ENTE Certificazione Macchine SRL (Italy) – 1282
  14. Eurofins Electric & Electronics Oy (Finland) – 0537
  15. Eurofins Product Testing Italy S.r.l. (Italy) – 0477
  16. GMED SAS (France) – 0459
  17. HTCert (Cyprus) –2803
  18. ICIM S.P.A (Italy) – 0425
  19. IMQ (Italy) – 0051
  20. Institut Pro Testovani A Certifikaci (Czech Republic - 1023
  21. Intertek Medical Notified Body AB (Sweden) – 2862
  22. Istituto Superiore Di Sanita’ (Italy) – 0373
  23. Italcert Srl (Italy) – 0426
  24. Kiwa Cermet Italia S.P.A (Italy) – 0476
  25. MDC Medical Device Certification (Germany) – 0483
  26. NSAI (Ireland) – 0050
  27. Polskie Centrum Badan I (Poland) - 1434
  28. SGS Belgium NV (Belgium) – 1639
  29. SGS Fimko OY (Finland) – 0598, ex: 403

  30. SLG Pruf and Zertifizierungs (Germany) - 0494
  31. Slovenian Institute of Quality and Metrology – SIQ (Slovenia) – 1304
  32. SZUTEST Konformitatsbewertungsstelle (Germany) – 2975
  33. TUV Nord Polska (Poland) – NB 2274
  34. TÜV Nord Cert GmbH (Germany) – 0044
  35. TÜV Rheinland Italia SRL (Italy) – 1936
  36. TÜV Rheinland LGA (Germany) – 0197
  37. TÜV SÜD (Germany) – 0123
  38. UDEM Adriatic d.o.o. (Croatia) – 2696
  39. Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi Türkiye – 2764
  40. Scarlet NB B.V. (Netherlands) – 3022
  41. UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (Türkiye) – 2292
  42. Cesky Metrologicky Institut (Czech Republic) - 1383
  43. RISE Medical Notified Body AB (Sweden) – 3033
  44. TÜV SÜD Danmark (Denmark) – 2443
  45. MTIC InterCert S.r.l.(Italy) – 0068
  46. AFNOR Certification (France) – 0333
  47. Kiwa Belgelendirme Hizmetleri A.Ş.( Türkiye) – 1984
  48. QMD Services GmbH – Austria - 2962
  49. NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) (Hungary) - 1011
  50. Kiwa Assurance B.V. - Netherlands - 1912
  51. NOTICE, storitve ugotavljanja skladnosti, d.o.o. - Slovenia - 3121
  52. Malta Conformity Assessment Ltd. - Malta - 3132

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

  1. 3EC International (Slovakia) – 2265
  2. Centro Nacional de Certificación de Productos Sanitarios (Spain) – 0318
  3. DEKRA Certification (Germany) – 0124
  4. DEKRA Certification (Netherlands) – 0344
  5. GMED SAS (France) – 0459
  6. MDC Medical Device Certification (Germany) – 0483
  7. National Standards Authority of Ireland (Ireland) - 0050
  8. QMD Services (Austria) – 2962
  9. TÜV Rheinland LGA Products (Germany) – 0197
  10. TÜV SÜD Product Service (Germany) – 0123 
  11. Eurofins Electric & Electronics Finland Oy – 0537
  12. Sertio Oy (Finland) – 3018
  13. Istituto Superiore Di Sanita' (Italy) – 0373
  14. IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. (Italy) – 0051
  15. SGS Belgium NV (Belgium) – 1639
  16. BSI Group The Netherlands B.V.(Netherlands) – 2797
  17. DNV Product Assurance AS (Norway) – 2460
  18. POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (Poland) – 1434
  19. SGS FIMKO OY (Finland) - NB 0598 ex:403

UK approved bodies:

  1. BSI ASSURANCE UK LTD (0086)
  2. DEKRA CERTIFICATION UK LTD (8505)
  3. Eurofins E&E CML Limited (2503)
  4. Scarlet NB UK Ltd (8536)
  5. SGS United Kingdom Ltd (0120)
  6. UL International (UK) Ltd (0843)
  7. TUV Rheinland UK Ltd (2571)
  8. TUV SUD BABT Unlimited (0168)
specific content in your email template using this boxed text block.

   

Product Commercialisation

__________

Article to help your journey in commercialisation

   

FINDING DISTRIBUTION CHANNELS

A MedTech Trade Show. Lots of people


A group walks past a booth. The CEO eagerly approaches:

“Hello, would you like to know more about our device?”


They happen to be from a distributor company. They stop, listen, and eventually ask, “How much does it cost?”

The CEO shares the MOQ pricing.

“OK, can you give us your brochure? We’ll discuss internally.”

Brochure. Business card. Goodbye.

Then it happens again. And again. Pretty much the entire day.


Lots of conversations, lots of contacts — yet somehow, there is a sense of emptiness.

There is nothing wrong with “we’ll discuss internally”. A distributor should evaluate whether a device fits its portfolio. But did they ask how the device fits into the country’s healthcare system? Which channels or business models might work? Who would use it? What about maintenance or disposal?


Price tells you they are listening. 

Market questions tell you they are thinking.


A distributor willing to discuss the device’s integration, use case, business model and market conditions is showing a different level of interest. Better still if they are willing to share what they know about their market.

That is a conversation worth pursuing.

And if, after an entire trade show, all you have is a stack of business cards and a bunch of “we’ll discuss internally” conversations, perhaps there is another question to ask:

Was this the right event to be at in the first place?


For us, we are always interested. When you speak to us, you should always walk away having learned something.


   

Special Feature

__________
     
   

MEDICAL FAIR ASIA 2026 was held from 9–11 September 2026 at Marina Bay Sands, Singapore, bringing together the region’s MedTech community, including medical device manufacturers, distributors, healthcare professionals and industry partners. Across the three-day event, participants explored emerging medical technologies, exchanged industry insights and connected over opportunities in market entry, regulatory pathways and MedTech commercialisation across Asia-Pacific.


For more information, visit our blog for some of the event highlights, conversations and key moments from MEDICAL FAIR ASIA 2026!


   

Upcoming Events

__________

MedTech Gatherings happening in October 2026!

   

Malaysia MedTech Industry Summit 2026

G Hotel Gurney, Penang, Malaysia 

Oct 8–10, 2026

More info ⟶

AusMedtech Conference Gold Cost 2026

Gold Coast Convention & Exhibition Centre, Queensland, Australia

Oct 21–22, 2026

More info ⟶

China International Medical Equipment Fair (CMEF) 2026 

Oct 21–24, 2026

More info ⟶

Smart Health Asia 2026

Geneo, Singapore

Oct 26, 2026

More info ⟶

   
   

Follow Us On

 You are receiving this email as you signed up for our newsletters.

 Want to change how you receive these emails?

You can Unsubscribe or Update your preferences

   
__________