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July’s been a whirlwind (just see how many countries have typhoons looming at the moment!) — and for us, it also marks the launch of our new Hong Kong office! If the Greater Bay Area is your next destination, Access-2-Healthcare is ready when you are. 

   
   

IN-COUNTRY FOCUS

     

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

   

INDIA

WHO unveils AI roadmap for traditional meds

The World Health Organization (WHO) has released its first-ever roadmap for applying Artificial Intelligence (AI) in traditional medicine, following India’s proposal. Titled "Mapping the Application of AI in Traditional Medicine," the document highlights India’s efforts like the Traditional Knowledge Digital Library (TKDL), Ayurgenomics, and digitized practices in Ayurveda and Yoga. 

   

EUROPE & CHINA

EU and China Escalate Trade Restrictions

The EU has barred Chinese medical companies from bidding on EU public tenders over €5 million to ensure reciprocity in procurement access. In response, China imposed a ban on EU-origin medical devices in government procurement over ¥45 million (~$6.3 million) and limited EU-sourced medical content in third-party bids—covering contracts for non-EU firms.  

   
   

INDUSTRY INSIGHT 

     

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

   

UNITED STATES

MIT develops implantable device to automatically 

release emergency glucagon

MIT engineers have created an implantable device that automatically releases emergency glucagon when blood sugar drops too low—providing vital protection for people with Type 1 diabetes, especially during sleep or when unable to self-administer injections. The device may also deliver emergency epinephrine in critical situations. Published in Nature Biomedical Engineering, the research marks a major advancement in automated emergency response for chronic conditions. 

   

AUSTRALIA

$100 million to support Australian medical innovations

The Albanese Government has committed nearly $100 million to support emerging Australian biomedical and medical technology innovations. Funding was awarded to Brandon BioCatalyst, ANDHealth Pty Ltd, and Bionitelect Pty Ltd, which will serve as incubators to help SMEs commercialise new medical products. This initiative, under the Medical Research Future Fund, is expected to provide $450 million over 10 years to boost Australia’s MedTech sector. 

   
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SINGAPORE

HSA publishes revised GN-09 Guidance and 

upgraded MEDICS to SHARE

Revision 4 of GN-09 Guidance on the Component Elements of a Dear Healthcare Professional Letter and 4 of GN-10 Guidance on Medical Device Field Safety Corrective Action, are finalised and these guidances can be accessed from HSA Guidance documents at the below medical devices webpage. As of 14th July, HSA MEDICS has been upgraded to SHARE (Singapore Health Product Access and Regulatory E-System).

   

HONG KONG

Hong Kong Centre for Medical Products Regulation 

to be established by the end of 2026

The Hong Kong Department of Health has announced its plan to establish the Centre for Medical Products Regulation (CMPR) by the end of 2026. Legislative proposals are expected within the coming year, reflecting the government’s commitment to strengthening its regulatory framework and advancing independence in the oversight of medical products.

   

INDIA

India's CDSCO releases Addendum 02 to FAQs on Medical Devices

The Central Drugs Standard Control Organization (CDSCO) has issued Addendum 02 to its Frequently Asked Questions (FAQs) on medical devices (Doc No.: CDSCO/FAQ/MD/01/2024). Released on 9 July 2025, this update offers clearer guidance on licensing, importation, classification, and other regulatory requirements under India’s Medical Device Rules. 

   

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

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

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

Establishing channels – can you commit? 


It's tempting to think, “Let’s just hand it off to a distributor who knows the market.” And in the early stages, that may seem like the right call—experienced distributors often have deeper networks, stronger doctor relationships, and local knowledge.


But how do you know which distributor is the right one? Sure, reputation, doctor networks, and familiarity with your clinical segment are important. But the most critical factor? Commitment.


Commitment means having a commitment to continue to propagate whatever the manufacturer had propagated, either through sales, through clinical education within the market. Commitment means having customer support after sales, to maintain the customer relationship.  Commitment means not just knowing the clinical workflow, but studying intently to see how this workflow can improve outcomes. 


Commitment also happens on the other end – the manufacturer. Commitment to initially seed the investment through a go-to-market strategy instead of just relying on distributors. Commitment through providing product knowledge, training, sharing the successes and learning the failures of other markets and partners. Commitment through venturing together and not just relying on the distributor to ‘pay for it all as a sign of commitment’. 


Distributors remain the most common route to market. But success lies in mutual commitment, trust, and ongoing collaboration—not just contracts.


Ready to build a committed channel strategy that scales with your growth?

   
   

Special Feature

     
   
   

Access-2-Healthcare at Japan Health 2025!


Held in June 2025 at INTEX Osaka, Japan Health 2025 marked the launch of a brand-new international trade show dedicated to the medical and healthcare industries. The event brought together medical device manufacturers, startups, research institutions, and public agencies from Japan and beyond to showcase cutting-edge technologies and healthcare services. Officially part of EXPO 2025 Osaka, Kansai – Health & Wellbeing Week, the exhibition gained global attention as a key event during the Expo. We were so excited to be a part of this event  read more about our blog post!

   
   

UPCOMING EVENTS

     

Key MedTech Events to Catch in July!

   

AHRMM25 Annual Conference

Denver, Colorado, USA

August 3-6, 2025

More info ⟶

The International Forum on Quality and Safety in Healthcare

Brussels, Belgium

August 13-15, 2025

More info ⟶

RISE West 2025

Paris Las Vegas, Las Vegas, NV, USA

August 25–27, 2025

More info ⟶

AMEE 2025

Barcelona, Spain

August 23-27, 2025

More info ⟶

Asia Patient Experience and Healthtech Summit Bali 2025

Bali, Indonesia

August 28-29, 2025

More info ⟶

   
   

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