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Yodeling is a singing technique that rapidly alternates between a low-pitch chest voice and a high-pitch falsetto head voice. Originally, herders in the Alps used it as a functional communication tool to call livestock, signal between mountain villages, and project their voices across vast distances. While now we have the internet, email, and messaging platforms, communication needs never wane, and in fact today we need more of it, and therefore Access-2-Healthcare faithfully sends our MedTech Gateway to you. The event season ramps back up in August, with gatherings across Hong Kong, Singapore, and Kuala Lumpur.

   
   

IN-COUNTRY FOCUS

     

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

   

SOUTH KOREA

Korea revises Health Cooperation MOU with Mongolia after 15 years

South Korea’s Ministry of Health and Welfare signed a revised Health Cooperation Memorandum of Understanding with Mongolia, expanding collaboration in healthcare workforce training, cancer research, and public-private partnerships. The agreement strengthens regional healthcare cooperation and supports long-term health system development.

   

UNITED KINGDOM

UK updates Life Sciences Sector Plan to drive health innovation

The UK Government published its updated Life Sciences Sector Plan, outlining measures to strengthen regulation, expand clinical research, improve access to health data, and accelerate patient access to innovative medicines and medical technologies, reinforcing the UK’s long-term healthcare innovation strategy.

   
   

INDUSTRY INSIGHT 

     

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

   

SINGAPORE

Boustead expands healthcare technology portfolio with majority stake in UroMedTech

Boustead Medical Care Holdings acquired a 60% stake in UroMedTech through a S$6 million investment. The acquisition supports the commercialisation of UroMaster®, a robotic platform for prostate cancer diagnostics, strengthening Singapore’s precision medicine and healthcare technology ecosystem.

   

JAPAN

Japan launches MedTech BOOT programme to accelerate medical device startups

Japan’s MEDISO launched the MedTech BOOT programme to support medical device and Software as a Medical Device (SaMD) startups through mentoring, business development, and commercialisation support. The initiative aims to accelerate innovation and strengthen Japan’s medtech ecosystem.

   

CHINA

NMPA approves head gamma stereotactic radiotherapy system

China’s National Medical Products Administration (NMPA) approved a head gamma stereotactic radiotherapy system for market, expanding access to advanced precision radiotherapy technologies. The approval supports innovation in cancer treatment and reflects China’s continued advancement of high-end medical device development.

   
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UNITED KINGDOM

MHRA secures convictions over falsely marked baby feeding devices

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) secured convictions following a long-running investigation into falsely marked baby feeding devices. The case reinforces the importance of regulatory compliance and strengthens oversight of medical devices placed on the UK market.

   

OMAN

Oman strengthens registration requirements for high-risk medical devices

July marks the commencement of mandatory registration requirements for high-risk medical device manufacturers and their products in Oman. Under the new framework, eligible devices must be registered before shipment release. The Ministry of Health has also provided an extension period to support industry compliance during implementation.

   
   

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)
  9. INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532)

   
   

PRODUCT COMMERCIALISATION 

     

Articles to help your journey in commercialisation

   

FINDING DISTRIBUTION CHANNELS

Business Due Diligence


Option 1, 2, 3 .. and ..? 

Due Diligence and their options Outsourcing is very common. We outsource more than we think we do (think plumbers..) and finding the right OEM, CDMO, CRO and so on, goes beyond just finding the best there is, but the right fit. 


What is the right fit? 

Size – if the organisation size of both parties is far apart, be prepared to deal with bureaucracy of the larger one. If the larger party ‘looks down’ on the other, that is an immediate red flag regardless of their reputation. 

Fit – if one party is trying to ‘force fit’ their device to the outsourcing party, or the other party, hungry for business, just says ‘yes’ to anything and everything. It sounds great initially, but with mismatched expectations, things sour quicker than milk in open air. 

Culture – this goes beyond finding people of the same country, race, diet or personal interest 😊 Putting it more directly, it is the mix of being transactional and being relational. Different organisations apply this mix differently, and having common ways of working helps a great deal. 


And what do you know – that is just step ONE! 

Then comes the objective parts – background check, due diligence processes such as online and on-site assessments. If the earlier bits are sorted out, when organisations invest further on the due diligence process, the likelihood of success naturally increases. A part of ‘fit’ and a part of ‘culture’ will always form part of this due diligence process, and it’s our job to detect, determine and decide.



   
   

UPCOMING EVENTS

     

MedTech Gatherings happening in August 2026!

   

MedTech World Asia | Hong Kong 2026

Hong Kong Convention and Exhibition Centre(HKCEC), Wan Chai, Hong Kong. 

August 26-28, 2026

More info ⟶

HIMSS26 APAC Conference & Exhibition

Sands Expo & Convention Centre, Singapore

August 23–25, 2026

More info ⟶

IMDEC 2026 (International Medical Device Exhibition & Conference)

Kuala Lumpur Convention Centre

August 26-28, 2026

More info ⟶

FDA Public Meeting on MDUFA VI Reauthorization

Virtual

August 5, 2026

More info ⟶


Asia Primary Angioplasty Congress (APAC) 2026

Singapore

August 15-16, 2026

More info ⟶

Malaysia Pharma & Healthcare Expo (MPHC) 2026

Kuala Lumpur Convention Centre, Malaysia

August 26-28, 2026

More info ⟶



   
   

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