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As typhoons test resilience across China, they remind us how quickly conditions can change and why readiness matters. This month, Singapore has moved to tighten medical device cybersecurity and health-data governance, while China introduces new medical device industry standards and regional healthtech activity continues. Looking ahead, MEDICAL FAIR ASIA and the IMDRF Management Committee meeting are set to take place in September, bringing key stakeholders together across the region. We’re also proud to share that Access-2-Healthcare has been shortlisted for the MedTech World Awards Asia 2026, with public voting now open. Access-2-Healthcare, now in a refreshed layout, stands ready for what comes next. Here's your August edition!

   

In-Country Focus

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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

SINGAPORE

Singapore updates Health Information Act implementation guidance  

Singapore released Version 2.0 of its Health Information Act Implementation Guide to help healthcare providers prepare for Health Information Act requirements. The revised guide adds more detailed implementation steps and self-help technical guidance on cyber and data security, which is relevant to MedTech companies supplying connected devices, remote-monitoring tools, clinical software, and health-data platforms.

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VIETNAM

Hanoi accelerates free health checks and electronic health records

Hanoi is accelerating its citywide free health-check programme, with more than 953,000 residents and workers examined as of 15 August and a dedicated campaign for students beginning on 18 August. Alongside preventive screening, health facilities are updating electronic health records linked to citizen identification, supporting the city’s broader move towards integrated, long-term population health management.

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Industry Insight

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ANNOUCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

AUSTRALIA / SOUTHEAST ASIA

Austrade supports Australian healthtech engagement in Southeast Asia

The Australian Trade and Investment Commission (Austrade) reported activity supporting Australian healthtechproviders’ engagement with Southeast Asian healthcare markets through a regional healthcare exhibition. The initiative signals continued public-sector support for cross-border commercialisation, partnerships, and market-development opportunities for health-technology suppliers in the region.

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MALAYSIA

VentureTECH invests RM28 million in three Malaysian technology companies

VentureTECH has invested a combined RM28 million in three Malaysian technology companies, supporting the growth of homegrown innovation and high-value capabilities. The investment reflects Malaysia’s continued focus on helping technology businesses scale, strengthen their commercial potential and contribute to the country’s next wave of innovation.

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Regulatory Roundup

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ANNOUCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

SINGAPORE

HSA releases final medical-device cybersecurity best-practices guide  

Singapore’s Health Sciences Authority (HSA) published its response to feedback from the public consultation on its Best Practices Guide for Medical Device Cybersecurity, alongside the finalised guide. The update provides a reference for manufacturers and other supply-chain stakeholders managing cybersecurity across connected and software-enabled medical devices in Singapore.

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CHINA

NMPA publishes 46 medical device industry standards

China’s National Medical Products Administration (NMPA) approved and published 46 medical device industry standards, including YY 0055—2026 for dental light-curing units. The announcement sets out the standard numbers, titles, scopes and implementation dates, providing updated technical requirements for affected medical device categories.

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UNITED KINGDOM

MHRA issues national patient-safety alert for ResMed Astral ventilators

The MHRA issued a National Patient Safety Alert for ResMed Astral 100 and 150 ventilators and certain spare parts manufactured before October 2024. An internal supercapacitor may leak and damage circuitry, potentially causing an unexpected interruption to ventilation therapy; affected healthcare providers must 

identify devices, put risk controls in place, and ensure ventilator-dependent patients 

have backup arrangements within one 

month.

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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)
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Product Commercialisation

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Article to help your journey in commercialisation

   

GOING TO MARKET

A Walk in the Park 

Along with a Go-To-Market Strategy Call


A phone call rang while I was talking a walk along Chaoyang Park in Beijing one day 

It was a potential client, who had moved on to another company, and rang back to chat on a few things. 


“We have an IVD device in development, do some countries accept RUO arrangements?”

“Yes, it depends on whether the lab is willing to work with you on this”

“Is there a distributor or a group that you can introduce?”

“Unless you find a person that is already extremely interested in your oncology-based IVD from the get-go, you have to find a lab that is willing to work with you”

“So, there’s a chance? Wow…”

“But firstly did you do a quick market scan? We have many more tools today that are available for secondary market research”

“ok I will do it later”

“The basics is at least to know who are your potential competitors that are already in the market, and whether there are already labs offering the same or similar solutions. This can be found online” 

“yeah.. right.. ok.. I will check that” 

“OK if you’d like us to see what’s it like and give a quick go/no go, no problem just send to us. We nearly came close to working together anyway” 

“Sure I’ll do that.. Thanks!” 


The basics cannot be skipped.

1. Quick check secondary market study  

Check the competitors, clinical workflow, medical condition prevalence, and whether the market cares enough.

2. Reach out before travelling 

Outreach a bit, get some recommendations, all to justify a visit and meet some people face-to-face.

3. Test your assumptions 

Based on the secondary market study, speaking with various parties to test your assumptiomns-- but do not pitch yet.

4. Then prospect 

if it works, the next trip, you can prospect 

 

Notice that we did a check first before spending money for the trip?  

No investment, go gain.


Want to know how quickly we can understand your device’s go-to-market strategy—and get a preview of our economic evaluation tool?


     
   

Upcoming Events

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MedTech Gatherings happening in September 2026!

   

Medical Fair Asia 2026

Marina Bay Sands, Singapore

September 9–11, 2026

More info ⟶

30th IMDRF Management Committee Meeting

Singapore

September 14–18, 2026

More info ⟶

Medical Fair India 2026 – 32nd International Exhibition & Conference

Bombay Exhibition Center (BEC), Mumbai, India

September 17–19, 2026

More info ⟶

MTAA RegConnect Summit 2026

ICC Sydney Convention Centre, Sydney, Australia

September 24–25, 2026

More info ⟶

   
   

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