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Happy Birthday! :) 

Oh, that may have been yesterday (or still the correct day for those across the Atlantic), as the 7th day of the Lunar New Year is known as 人日 or everyone's birthday). Access-2-Healthcare also reached its 11th year, and we will be looking towards more f2f engagement with our ecosystems and making them work together in a more efficient manner, to ultimately serve patients better than it has ever been.

   
   

IN-COUNTRY FOCUS

     

WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?

   

INDIA & BRAZIL

India and Brazil exchange MoU to strengthen cooperation in pharmaceutical and medical products regulation

On 21 February 2026, India and Brazil signed an MoU to enhance cooperation in regulating pharmaceutical and medical products. The agreement was exchanged between Central Drugs Standard Control Organisation (CDSCO) and Brazilian Health Regulatory Agency (ANVISA), aiming to establish a structured framework for information sharing on drugs, biologics, APIs, and medical devices.

   

MALAYSIA

MOH allocates over RM137 million to strengthen NCD prevention 

The Ministry of Health (MOH) has allocated more than RM137 million this year to strengthen early prevention of non-communicable diseases (NCDs) following a rise in diabetes and heart disease complications, which are placing pressure on the national healthcare system. The specific allocation is channelled through several initiatives, involving health screening, treatment and healthy nutrition advocacy.

   
   

INDUSTRY INSIGHT 

     

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

   

UNITED STATES

Danaher to acquire Masimo Corporation

Danaher acquired patient monitoring company Masimo for $9.9 billion to bolster its diagnostics franchise. Masimo will become a standalone business unit and brand within Danaher’s diagnostics portfolio, operating autonomously while strengthening Danaher’s offering in acute care settings.

   

UNITED STATES

Natus Sensory acquires TheraB Medical to expand innovation in neonatal phototherapy

Natus Sensory, a global leader in sensory and newborn care solutions, has acquired TheraB Medical, a medtech company developing wearable phototherapy for neonatal jaundice. The deal expands Natus Sensory’s newborn care portfolio by adding the first FDA-cleared, swaddle-style wearable phototherapy system, enabling effective treatment while improving flexibility and family-centered care.

   

UNITED STATES

Grail shares plummet after UK study raises doubts over cancer test's prospects

Grail's (GRAL.O), opens new tab shares plunged nearly 50% on Friday after the company said routine screening with its cancer blood test failed to significantly boost early detection and reduce late-stage diagnoses in a pivotal three-year UK trial. The results of the trial, released by Grail late on 20 Feb 2026, cast doubt on the test's commercial prospects.

   

CHINA

China approves Blackstone & TPG’s $18.3 Bn acquisition of Hologic

China’s State Administration for Market Regulation (SAMR) has approved private equity firms Blackstone and TPG’s proposed acquisition of medical diagnostics company Hologic. The approval marks a key regulatory milestone for the $18.3 billion transaction, including debt, which was announced in October. The deal is considered the largest medical devices acquisition in nearly two decades.

   
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UNITED KINGDOM

Medical devices regulations: targeted consultation on the indefinite recognition of CE-marked devices

The Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on proposals for indefinite recognition of CE-marked medical devices in Great Britain (GB), aimed at protecting patient access and ensuring the continued supply of safe and effective medical technologies.

   

INDIA

Health Ministry appoints 27 Government Analysts as Medical Device Testing Officers

On 19 February 2026, India’s Ministry of Health and Family Welfare appointed 27 government analysts as Medical Device Testing Officers under the Medical Devices Rules, 2017. Issued under the Drugs and Cosmetics Act, 1940, the notification replaces the December 2024 order and authorizes national and regional labs to test specified medical devices.

   

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

   

READY FOR MANUFACTURING 

Covering All the Bases 


I visited a manufacturer a while ago, who had just rented their space, placed their benches, and started to put their assembly and test equipment together. Housed in a humble industrial estate, when the locked door opened, what greeted our eyes was a brightly lit space still work in progress, but with clear signs of organisation. 


We went on to discuss the process of design transfer 

- who can be your suppliers just around your neighbourhood? 

- how much PQ (performance qualification) product may be available for first sales 

- did you get your revised QMS certification scope correct? 

- when to purchase new and when to acquire used equipment. 

Highly operational questions that need equally operational answers - making friends with the neighbours who turned out suppling some equipment for them, and therefore ensuring great service support; working out the statistics and checking commercial demand for the PQ lot; ensuring the audit scheduling is sync-ed to save time and cost for all; checking total cost of ownership including service, maintenance, utilization and cost amortization and so on. 


Important lessons to learn: 

- Be fast by planning the step by step and getting tasks cleared, but not rush by thinking things through 

- Always ensure the team aligns in information and make decisions together. 

- Do not over plan and lose track of actually executing. 

- Having the first 2 years making product yourself, sets up a great foundation for oursourcing later. It’s NOT the other way around. 


If you are planning on a design transfer, or setting up a manufacturing site. Let us know!


   
   

SPECIAL FEATURE

     
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World Health Expo (WHX), formerly known as Arab Health, was successfully held in Dubai from 9–12 February 2026, and Access-2-Healthcare was delighted to be part of it. WHX has always been great to showcase not just MedTech but HealthTech, regulatory and government organisations, hospital groups (this time the first time seeing some of the reputable public hospitals from China). It also gathered people of all races and showed that if some product is good, it will be good anywhere in the world. We also had a chance to engage with MedTech companies and medical device leaders globally. 


Visit our blog to read our highlights at the event!


   
   

UPCOMING EVENTS

     

MedTech Gatherings happening in March 2026!

   

health.tech global summit 2026 

Basel, Switzerland

March 3-5, 2026

More info ⟶

HIMSS26

Venetian Convention & Expo Center, United States

March 9-12, 2026

More info ⟶

Medical Japan Osaka 2026 

INTEX Osaka, Japan

March 10-12, 2026

More info ⟶

KIMES 2026

COEX, Seoul, Korea 

March 19-22, 2026

More info ⟶

   
   

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