https://stratus.campaign-image.com/images/147340000024305004_zc_v1_1751534271078_head_banner_(8).png
   

This month's issue highlights some major regulatory shifts and overall market movements in the MedTech landscape - from the U.S. FDA funding lapse to Brazil’s digital regulatory rollout, to Japan’s AI-driven review strategy. The industry players are also driving momentum through major restructurings, IPO activity, cross-border investments, and impactful healthcare policy changes across markets, including Hong Kong and India. Never a dull day with Access-2-Healthcare!

   
   

IN-COUNTRY FOCUS

     

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

   

HONG KONG

Hong Kong expands data, EHR, telehealth

Chief Executive John Lee announced a series of initiatives to accelerate healthcare innovation, including cross-border data sharing with the Greater Bay Area, faster drug and device approvals, the establishment of a new regulatory centre, and expanded telehealth services.

   

INDIA

NMC to ban promotion of medical devices and companies 

during live surgeries

Aiming to make regulations for live surgery procedures clearer and more practical, India plans to ban the promotion and marketing of medical devices and companies during educational live surgeries, according to Dr. Abhijat Sheth, Chairman of the National Medical Commission (NMC), as reported by Mint.

   
   

INDUSTRY INSIGHT 

     

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

   

UNITED STATES

Johnson & Johnson announces intent to separate 

its Orthopaedics business

First they acquire - now they divest! Johnson & Johnson plans to separate DePuy Synthes, its franchise of orthopaedic and neurosurgery companies, into a standalone company within the next 18 to 24 months, marking its second major spinoff in two years. DePuy develops and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics, and DePuy Spine brands

   

INDIA

Everstone-backed Integris Medtech files for Rs 925 Crore IPO

Integris Medtech, the second largest Indian headquartered diversified medical technology platform in terms of operating revenue for FY25, has filed its Draft Red Herring Prospectus (DRHP) with market regulator Securities and Exchange Board of India (SEBI). The IPO comprises of a fresh issue of equity shares of face value Rs. 1 each aggregating up to Rs. 925 crore and an offer for sale of up to 21,674,531 equity shares of face value Rs. 1.

   

SINGAPORE

CBC Group raises $500 million for the Asia's largest 

healthcare private credit fund

CBC Group, Asia’s largest healthcare-dedicated asset management firm, today announced the closing of its R-Bridge Healthcare Fund II (“RBF II”) with $500 million in total capital commitments. RBF II invests on a global basis whilst supporting healthcare innovation and the growth of healthcare innovators.

   
https://stratus.campaign-image.com/images/799582000003039020_zc_v1_1696410227331_group_291.png
   

UNITED STATES

FDA will not accept submissions requiring fees until funding resumes

The U.S. FDA has announced that if no FY 2026 appropriation or Continuing Resolution is enacted by October 1, 2025, the agency will enter a funding lapse and will not be able to accept new user fee-funded submissions. During this time, FDA operations will be limited to mission-critical activities that protect public health — such as responding to foodborne illness outbreaks, monitoring high-risk recalls, and screening imported products.

   

BRAZIL

Anvisa launches new digital form for international users

Brazil's 2025 Contact US form provides foreign users with a dedicated channel to submit questions and access regulatory information directly. This digital modernization effort enhances accessibility, transparency, and international engagement while traditional channels remain available for Brazilian users.

   

JAPAN

Action Plan for the Use of AI in Operations at the PMDA

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan announced its Action Plan for the Use of AI in Operations in October 2025. The plan serves as a guideline for integrating artificial intelligence technologies into the agency’s review, evaluation, and administrative processes.

   

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. – 1434

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

   

FUNDING: TURNING THE TABLES 

How to survive in the funding winter?


With funding winters, unable economies, conservatism, those that did not actively pursue revenue, strategic partnerships, or government initiatives 5-6 years ago are truly suffering at the moment. Hindsight’s always 20-20, so what methods can companies try to gain that bridging round of funds to just get over the hump? 

Revisit your product’s user and patient focus.
Instead of pushing your narrative, look inward and track the comments and feedback received and demonstrate engagement with your users. What does it gain? Possible adoption studies, in which the funds may be gained to further these studies.

Strategic partners bring quicker market expansion.
Some of the best distributors are manufacturers themselves – why? Because they would have tried initially to market within their own country, so would already have some traction or network. Some would work when packaged with other devices for an integrated approach to the same group of users. 

 Hanging by a thread is not sustainable unless …. 
… unless it is a case where the market is not yet ready but is gradually gaining acceptance. Then it would work well to hang on just a bit more to see it turn the corner. If not? It’s ok to cut losses and try again, your earlier investors will appreciate it too, as their funds recovered can be more quickly re-deployed. 

Note that none of the ways is about another creative way to approach VCs or some crowdfunding tactics – it no longer work. The tables have to be turned where the funders are coming after companies with good turnover (i.e., revenue and expenses), and looking to scale or become really profitable. 

Let's navigate this funding winter together

   
   

UPCOMING EVENTS

     

MedTech Gatherings happening this November!

   

MEDICA 2025

Düsseldorf, Germany

November 17 - 20, 2025

More info ⟶

MIH Megatrends 2025

Kuala Lumpur, Malaysia

November 25 - 27, 2025

More info ⟶

ABHI UK HealthTech Conference 2025

London, United Kingdom

November 11 - 12, 2025

More info ⟶

Medicare Expo 2025

Ho Chi Minh City, Vietnam

November 27 - 29,  2025

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