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The past month continued to buzz with international events, even after the F1 Singapore Grand Prix — all of which we’ve captured in this issue’s special feature. We also spotlight key cross-border collaborations, from India and Japan strengthening their MedTech partnership to Vietnam and Japan deepening their healthcare ties. Explore these highlights with Access-2-Healthcare!

   
   

IN-COUNTRY FOCUS

     

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

   

INDIA & JAPAN

India–Japan MedTech Partnership accelerates with 

High-Level Meet at YEIDA Medical Devices Park

In a significant step towards strengthening Indo-Japanese collaboration in MedTech sector, a high-level meeting was convened at the Yamuna Express Industrial Development Authority (YEIDA) Medical Devices Park. The discussions focused on enhancing bilateral cooperation, exploring joint ventures, and encouraging Japanese investment in India’s rapidly expanding medical devices industry.

   

VIETNAM & JAPAN

Minister Dao Hong Lan held bilateral talks with the Governor of 

Kanagawa Prefecture to promote Vietnam-Japan medical cooperation.

On the morning of November 14, at the headquarters of the Ministry of Health, Member of the Party Central Committee, Minister of Health Dao Hong Lan received, worked and held bilateral talks with Mr. Kuroiwa Yuji, Governor of Kanagawa Prefecture to promote medical cooperation between the Ministry of Health of Vietnam and Kanagawa Prefecture, Japan.

   
   

INDUSTRY INSIGHT 

     

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

   

GERMANY

Siemens to reduce stake in Siemens Healthineers

Siemens will transfer 30% of Siemens Healthineers shares to Siemens shareholders, giving up its controlling stake in the imaging and diagnostics company. The move will allow Siemens, which now holds a 67% stake in Siemens Healthineers, to focus on its core technology portfolio with greater capital allocation flexibility.

   

HONG KONG

Cornerstone Robotics raises $200m for technology advancement

Hong Kong-based Cornerstone Robotics has raised around $200m in its funding round, mainly to expedite commercialisation plans and propel technology advancements. The oversubscribed financing round saw participation from an international investor, several global institutional and sovereign wealth funds, as well as current backers.

   
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CHINA

NMPA released the Good Manufacturing Practice for 

medical devices ([2025] No. 107)

To strengthen quality management, regulate manufacturing activities, and ensure the safety and effectiveness of medical devices in China, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and the "Provisions for Supervision and Administration of Medical Device Manufacturing", the NMPA has revised the Good Manufacturing Practice for Medical Devices. It is hereby released and shall come into force as of November 1, 2026.

   

EUROPE

EU countries start piloting coordinated reviews of 

medtech clinical trial filings

European Union Member States have launched a pilot coordinated assessment of clinical investigations and performance studies for medical devices. Supported by the European Commission, the pilot will allow sponsors to submit a single application for studies in multiple Member States. The coordinated assessments are intended to offer more harmonized interaction with the Member States approving the clinical investigation or performance studies.

   

EGYPT

Egyptian Drug Authority to strengthen international cooperation 

in medical device regulation

The Egyptian Drug Authority (EDA) participated virtually in the fifth Russian forum “Medical Devices Circulation – NOVAMED-2025”, with the participation of several international regulatory authorities and experts from the healthcare and medical sectors. Its representative addressed the national procedures for the registration and circulation of medical devices, the advantages offered by the Authority to foreign manufacturers seeking entry into the Egyptian market.

   

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

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

   

PROTOTYPE

Prototyping, Prototyping – how many more iterations to go? 

It doesn’t matter as long as 
- The iterations are costed and accounted for 
- The engineering department has the materials, tools, and technical expertise. 

While the first point is a function of the contract, the second point is a function of the selection and due diligence process. 

Many a times we have the founding team searching for a prototyping house, spent all the time investigating track record and completed work, but plain forgot to check the basics.
- Where’s your tools list? Are your tools and jigs able to prototype what I need to the required tolerance, and using the required materials? 
- Where are your engineers? Any of them have the required technical skills? Are they working on their own or in a team? 
- Where are these tools and engineers located? (Even if they are not in-house, that is ok as long as the company is transparent about it. 
- What is the charging model? Per prototype piece? How about subsequent pieces? Are they expecting larger volume manufacturing at a later date, or are they happy to prototype at a cost? 
- Where do your materials come from? Do you have what my material specifications say, or can you suggest them to us? 

Most of these questions can be answered rather quickly and succinctly, which makes it easy to evaluate suitability. If they are found acceptable, the next steps would be to see if communication is easy and how accessible it is for the client to visit. Even if it is an outsourced party, transparency is crucial, especially between the founders/research team and the engineering team. 

Once all of the above is clear, then wrap this around a written agreement, clear payment terms, delivery schedules, and termination clauses. Be clear that prototypes can fail, and a complete re-design may be necessary. 

Get your prototype ready with us!

   
   

SPECIAL FEATURE

     
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SWITCH AND TECHNOVATION 2025


This year’s SWITCH and TechInnovation were strengthened by a wide range of international delegation networking events, market-discovery visits, and thematic seminars—underscoring Singapore’s strong leadership in the global MICE industry in 2025. Kudos to the government agencies for their exceptional work in positioning Singapore as a premier destination for innovation and collaboration. 

We also had the opportunity to meet Nalagenetics, WomenX Biotech, and Loop Diagnostics—winners of various categories at Slingshot 2025—and we look forward to supporting their upcoming journey.

Explore some event highlights!

   
   

UPCOMING EVENTS

     

MedTech Gatherings happening this December!

   

GHWP 29th Annual Meeting Agenda version 2

Bangkok, Thailand

December 1-4, 2025

More info ⟶

Health Tech Forward 2025

Barcelona, Spain

December 3-4, 2025

More info ⟶

GIANT Health London 2025

London, United Kingdom

December 8-9, 2025

More info ⟶

Healthcare + Expo Taiwan 2025

Taipei, Taiwan

December 4 - 7, 2025

More info ⟶

World Health Innovation Forum 2025

Visakhapatnam, India

December 11-13, 2025

More info ⟶ 

Health 2.0 Conference

Dubai, UAE

December 8–10, 2025

More info ⟶

   
   

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