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This month’s cover is from Seoul, taken during a walk through one of its parks. A butterfly, a duck and some late flowers, all getting on with things without much fuss.


Across the region, healthcare is moving along too. Australia is bringing cancer screening closer to primary care, Indonesia has expanded mental-health screening, and South Korea is strengthening severe-trauma capacity. For MedTech companies, there are also new investments, clinical trials and regulatory developments to follow. And in product commercialisation, we look at a familiar QMS problem—the form everyone uses, but nobody quite knows where it came from. Clarity among the haze, Access-2-Healthcare always here. Your October edition awaits.

   

In-Country Focus

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WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

AUSTRALIA

Australia Strengthens National Cancer Screening Through Primary Care

 Australia is bringing cancer screening closer to communities, with resource packs now reaching over 7,000 general practices nationwide. Covering bowel, breast, cervical and lung cancer, the initiative helps GPs start screening conversations and encourage earlier detection.

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INDONESIA

Indonesia Expands National Mental Health Screening to 71.8 Million People

Indonesia's Ministry of Health reported that its national mental health screening programme has reached over 71.8 million people, identifying suspected depression symptoms in 1.2% and anxiety symptoms in 0.9% of those screened. The ministry also introduced four screening guidance booklets to strengthen follow-up care across different age groups at primary healthcare facilities.

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SOUTH KOREA

South Korea Strengthens Severe Trauma Care with Two Designated Hospitals

South Korea's Ministry of Health and Welfare announced the selection of Ajou University Hospital and Wonju Severance Christian Hospital to strengthen severe trauma treatment capacity. The government will provide up to KRW 7.71 billion per hospital for infrastructure, medical equipment and helicopter-related facilities, aiming to improve emergency care and reduce regional healthcare disparities.

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Industry Insight

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ANNOUCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

UNITED KINGDOM

Scarlet Raises US$50 Million to Expand AI Medical Device Certification Globally

UK-based Scarlet has secured US$50 million in Series B funding to expand its AI medical device certification services globally. The investment will support growth across Asia-Pacific and the US, helping medical technology companies navigate certification requirements and bring AI-powered healthcare innovations to market.

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INDIA

Translumina Launches Global Trial of Drug-Coated Balloons for Coronary Disease

India's Translumina Therapeutics has launched the SPARX Global clinical trial, involving 1,380 patients across 10 countries. The study will compare drug-coated balloons with conventional drug-eluting stents in treating complex coronary artery disease, aiming to generate new evidence for less implant-dependent treatment approaches.

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Regulatory Roundup

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ANNOUCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

INDONESIA

Indonesia Confirms October Halal Certification Deadline for Class A Medical Devices

Indonesia's BPJPH confirmed that mandatory halal certification for Class A medical devices will take effect on 18 October 2026, with no postponement. Requirements for higher-risk devices will follow in phases: Classes B and C by 17 October 2029, and Class D by 17 October 2034.

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JAPAN

PMDA Publishes English Translation of Draft Guidance for Generative AI Medical Devices

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) published an English translation of its draft review considerations for medical devices using generative AI. The guidance provides regulatory insights for manufacturers developing AI-powered medical technologies for the Japanese market.

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SINGAPORE

HSA and ACE Introduce Priority Track to Accelerate Healthcare Innovation

Singapore's HSA and Agency for Care Effectiveness (ACE) announced a new Priority Track launching in November 2026. The initiative allows selected innovative health products to undergo regulatory evaluation and health technology assessment concurrently, potentially shortening assessment timelines from around 12 months to 6–9 months after regulatory approval.

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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

   

QUALITY MANAGEMENT SYSTEM

Whose form is this?


An audit room, day two. The auditor pulls out a completed form, signed, dated, filed neatly, and asks which procedure it comes from. Silence. Someone flips through the SOP index, another is quite sure it’s under purchasing, but it isn't...


A QMS orphan. Used every week, signed every week, but no parent SOP and nobody really owning it. Sometimes it’s the other way round, an SOP pointing to a form that disappeared two revisions ago.


How did it get there? Nobody planned it, that’s for sure. Usually it’s templates borrowed from a previous company, an SOP merged or split while the forms stayed put, a quick form to close an audit finding, someone leaving, or paper moving into an eQMS and the links not making the trip.


Does it matter, if the form is filled in properly? Ask the auditor 

When we built an interactive map of a QMS, linking SOPs to forms, records and ISO clauses, that’s where it helped. On a list an orphan hides quite comfortably, on a map it’s a dot with nothing going in or out.


Housekeeping, mostly. Link both ways, have change control ask what else a revision touches, give every document an owner, retire the obsolete ones properly.


And that form? Found it eventually, in an old version of the purchasing SOP.


Of course, if this sounds familiar, and let us know if you like to know more about the interactive map.


     
   

Upcoming Events

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MedTech Gatherings happening in NOVEMBER 2026!

   

MedTech world Europe 2026

Mediterranean Conference Centre, Valletta, Malta

Nov 11–13, 2026

More info ⟶

MEDICA & COMPAMED 2026

Messe Düsseldorf, Düsseldorf, Germany

Nov 16–19, 2026

More info ⟶

HOSPEX Japan 2026

Tokyo Big Sight, West Exhibition Hall 2, Tokyo, Japan

Nov  18–20, 2026

More info ⟶

Vietnam Medi-Pharm / VietMedicare Expo 2026

Saigon Exhibition and Convention Center (SECC), Ho Chi Minh City, Vietnam

Nov 25–27, 2026

More info ⟶


   

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