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This is probably the last day for “Happy New Year!” Wish everyone have had a great start to the year. Access-2-Healthcare concluded last year well, and bringing the momentum to this Quarter. We will be looking towards more f2f engagement with our ecosystems and making them work together in a more efficient manner, to serve patients better than it has ever been.

   
   

IN-COUNTRY FOCUS

     

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

   

INDIA

AiMeD asks Centre to raise import tariffs from 7.5% to 10-15% to boost domestic manufacturing of medical devices

The Association of Indian Medical Device Industry (AiMeD) has urged the Central Government to consider raising import tariffs to 10 to 15% from the current 7.5%, adopt quality-based criteria in public procurement with preference for Indian Certification for Medical Devices (ICMED) certification over foreign approvals, and updating labelling norms to disclose domestic content percentage and incentivise local value addition, in the upcoming Union Budget 2026-27.

   

AUSTRALIA & INDONESIA

Australia and Indonesia achieve WHO Listed Authority status in medical products regulation

The World Health Organization (WHO) has formally recognized the regulatory authorities for medical products of Australia and Indonesia as WHO Listed Authorities (WLAs), an achievement that underscores growing global confidence in regulatory systems across diverse regions and income settings.

   
   

INDUSTRY INSIGHT 

     

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

   

UNITED STATES

Boston Scientific to acquire bladder dysfunction company

Boston Scientific has acquired Valencia Technologies Corporation, a medtech company that focuses on developing and commercializing bladder dysfunction treatment solutions. The company’s flagship system, the eCoin System, is an implantable tibial nerve stimulation device for the treatment of urge urinary incontinence, which is a common symptom of an overactive bladder.

   

CHINA

Edge Medical lists in Hong Kong at $2.94 billion valuation

On January 8, Shenzhen Edge Medical Technology Co., Ltd., a surgical robotics company focused on multi-port and single-port laparoscopic systems, made its debut on the Hong Kong Stock Exchange (stock code: 2675.HK). Priced at USD 5.53 per share, the stock surged more than 38% at market open, giving the company an estimated valuation of USD 2.94 billion.

   

SWEDEN

EQT Life Sciences: 2025 Highlights and 2026 Outlook

After making five new investments in 2025, EQT Life Sciences is looking forward to a busy year, with portfolio companies anticipating several key milestones. EQT Life Sciences will continue to invest in line with its established strategies across biotechnology and medical technology, focusing on highly differentiated companies addressing areas of significant unmet medical need.

   
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UNITED STATES

FDA exempts more wearable, AI features from oversight

FDA released two notable final guidance documents regarding wearable and AI-enabled medical technologies designed to continue the administration’s promise of deregulating artificial intelligence and promoting its widespread use. Under the guidances, the FDA will limit oversight of general wellness wearables—such as fitness trackers—provided they make no diagnostic or treatment claims.

   

VIETNAM

Vietnam introduces a centralized procurement list for medical devices and diagnostics

Vietnam’s Ministry of Health issued a new centralized procurement list for medical devices and diagnostic supplies, effective March 1, 2026. The policy specifies which equipment and consumables will be centrally procured nationwide, aiming to lower costs and improve purchasing efficiency for high-volume medical devices and testing materials.

   

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

   

DESIGN, DEVELOPMENT AND CLINICAL SUPPORT

Busy , Busy Doctors 


All medtech startups were told to find some clinical expertise and support in their company. While some have the actual clinician hired, but most don’t. There’s also the need to conduct clinical studies, and of course, the key person is the principal investigator (PI) 


If there’s no KPI attached to their work, usually the doctors interested in clinical research, outside of their job, and their daily lives, is about 3% .... Yes, that’s about right - 3% 


However, this low percentage is not necessarily a disadvantage. This is because you can be sure that they will be committed as they have overcome all of their constraints 


That said, you can be sure there are more than this 3% that are interested, just that they didn’t know how. Is there some way to encourage them? Perhaps from this encouragement the percentage can increase? 


With more PIs, then the rest of the infrastructure will be set up such as the clinical research assistants getting hired. Revenue aside (as there will be the bulk of the cost of the clinical study going to the hospitals), the stature of the hospital may be improved due to this research component. Any clinical site will need some support - any importation, regulatory reporting, sponsor management, Access-2-Healthcare can take care.


Start your clinical studies together!

   
   

SPECIAL FEATURE

     
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Nakanoshima Qross was established in June 2024, thus joining (please find some out the information on how they combined the hospital an other things). Who firmly believes proximity and connectivity would foster more opportunities for clinical innovation to happen. Access-2-Healthcare is happy to have visited, and for more information, please visit their website.

   
   

UPCOMING EVENTS

     

MedTech Gatherings happening in February 2026!

   

World Health Expo Dubai 2026

Dubai Exhibition Centre, United Arab Emirates

February 9-12, 2026

More info ⟶

Medical Design & Manufacturing West 2026

Anaheim Convention Center, California, USA

February 3-5, 2026

More info ⟶

   
   

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