MedTech Gateway
 
ISSUE 65
 
JUNE 2024
 
 

Dear Esteemed Clients and Partners,

Access-2-Healthcare is thrilled to extend our warmest greetings to you. How apt, as our Group Executive Director is now presenting in the GHWP Leaders' Meeting in Bali! Further details in our "Regulatory Roundup" Section.

To address the need for rapid adaptation and response to the diverse changes in the Healthcare industry, ranging from regulatory shifts to emerging trends, we bring you our June edition.

 
 
 
REGULATORY ROUNDUP
 
THE LATEST REGULATORY UPDATES FOR THE
MEDICAL DEVICES INDUSTRY
 
 
AUSTRALIA
 
Proactive monitoring of highest-risk medical device clinical trials
 
 
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The Australian TGA is reviewing the safety information supporting notifications of the highest-risk implantable and cardiac invasive medical devices used in first-in-human clinical trials. This was part of the TGA’s commitment in the 2019 Action Plan for Medical Devices, and the changes have been made in response to feedback from the consultation on proposed regulatory changes for clinical trials of medical devices.
 
Learn More ⟶
 
HONG KONG
 
DH establishes Preparatory Office for Hong Kong Centre for Medical Products Regulation
 
 
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The Department of Health (DH) announced today (June 5) the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR) to put forward proposals and steps for the formal establishment of the CMPR, and to study the potential restructuring and strengthening of the regulatory and approval regimes for drugs and medical devices.
 
Learn More ⟶
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INDONESIA
 
GHWP TC Leaders Meeting & Capacity Building : Excellence in Medical Device Regulation & Innovation
 
 
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The Global Harmonization Working Party (GHWP) remains at the forefront of promoting collaboration and excellence in medical device regulation worldwide. Held on June 12th-13th in Bali, the GHWP TC Leaders Meeting & Capacity Building on Medical Device Regulation & Innovation aims to address critical issues facing the industry.

The meeting explored the following key topics: Update and Socialization of Medical Devices Technical Regulations, Requirements and Other Policies; Halal Awareness Training for Medical Devices; Indonesia GDPMD Training and Business Matching.

 
Learn More ⟶
 
 
 
DESIGNATED NBs
 
HERE IS THE LATEST LIST OF 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. Kiwa Dare B.V (Netherlands) – 1912
  26. MDC Medical Device Certification (Germany) – 0483
  27. NSAI (Ireland) – 0050
  28. Polskie Centrum Badan I (Poland) - 1434
  29. SGS Belgium NV (Belgium) – 1639
  30. SGS FIMKO OY (Finland) – 0598
  31. SLG Pruf and Zertifizierungs (Germany) - 0494
  32. Slovenian Institute of Quality and Metrology – SIQ (Slovenia) – 1304
  33. SZUTEST Konformitatsbewertungsstelle (Germany) – 2975
  34. TUV NORD Polska (Poland) – NB 2274
  35. TÜV NORD CERT GmbH (Germany) – 0044
  36. TÜV Rheinland Italia SRL (Italy) – 1936
  37. TÜV Rheinland LGA (Germany) – 0197
  38. TÜV SÜD (Germany) – 0123
  39. UDEM Adriatic d.o.o. (Croatia) – 2696
  40. Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi Türkiye – 2764
  41. Scarlet NB B.V. (Netherlands) – 3022
  42. UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (Türkiye) – 2292
  43. CESKY METROLOGICKY INSTITUT (Czech Republic) - 1383
  44. RISE Medical Notified Body AB (Sweden) – 3033
  45. TÜV SÜD Danmark (Denmark) – 2443
  46. MTIC InterCert S.r.l.(Italy) – 0068
  47. AFNOR Certification (France) – 0333
  48. SGS FIMKO OY (Finland) – 403
  49. Kiwa Belgelendirme Hizmetleri A.Ş.( Türkiye) – 1984
 
 

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

  1. 3EC International (Slovakia) – 2265
  2. BSI (Netherlands) – 3022
  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
 
 

UK approved bodies:

  1. BSI Assurance UK Ltd (0086)
  2. DEKRA Certification UK Ltd (8505)
  3. SGS United Kingdom Ltd (0120)
  4. UL International (UK) Ltd (0843)
  5. TUV Rheinland UK Ltd (2571)
  6. TUV SUD BABT Unlimited (0168)
  7. INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532)
 
 
 
 
IN-COUNTRY FOCUS
 
WHAT ARE THE LATEST IN HEALTHCARE POLICIES TODAY?
 
 
VIETNAM
 
Signing ceremony of the Aid Agreement for the technical support project "Upgrading medical equipment at Hospital K" funded by the Japanese Government as non-refundable aid
 
 
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On the morning of May 28, 2024, at Quan Su facility, K Hospital held a signing ceremony for the Aid Agreement for the technical support project "Upgrading medical equipment at K Hospital" by the Japanese Government. The non-refundable aid agreement between the Ministry of Health and the Japan International Cooperation Agency was witnessed by the Japanese Embassy in Vietnam and the Ministry of Foreign Affairs of Vietnam.
 
Learn More ⟶
 
AUSTRALIA
 
New investment: the fight against MND continues
 
 
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The Australian Government is stepping up the fight to find a cure for motor neurone disease (MND) with a multi-million-dollar investment. They are investing $2 million in 2024-25 to support innovative, safe, rigorous and high quality MND research projects.
 
Learn More ⟶
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CANADA
 
The Government of Canada introduces the Connected Care for Canadians Act
 
 
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Today, the Honourable Mark Holland, Minister of Health, introduced Bill C-72 the Connected Care for Canadians Act. This Act is about enabling Canadians to securely access their own health data, which will empower patient's decision-making and improve the care they receive from health providers in Canada. This Act outlines Canada's plan to enable a modern, connected care system, in which health information can be securely accessed by patients and shared between providers, when needed.
 
Learn More ⟶
 
 
 
INDUSTRY INSIGHT
 
ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE
 
 
UNITED STATES
 
Applied Medical Technology, Inc. redefines the standard of anesthesia care with its launch of IntelAir™, a nasopharyngeal airway
 
 
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Applied Medical Technology, Inc. (AMT), a global leader in manufacturing medical devices, today announced the debut of IntelAir™, a nasal airway support system. The single-use device is intended to ensure airway securement, avoid cannula migration, and maintain a clear airway.
 
Learn More ⟶
 
GERMANY
 
New competence center inaugurated in Rangendingen
 
 
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After three years of construction and a total investment of 90 million euros, a new production and development plant was inaugurated in Rangendingen near Tübingen on May 3rd. Germany will now be producing medical technology instruments for the global market at this location. The new 25,000 m² building meets the KfW Efficiency House Standard 40 Plus criteria, setting a new benchmark for the combination of industry and sustainability.
 
Learn More ⟶
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PRODUCT COMMERCIALISATION
 
ARTICLES TO HELP YOUR JOURNEY IN COMMERCIALISATION
 
 
GOING TO MARKET
 
Go to Market Strategy
 
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Process flow
 

Nuts and bolts of product-market fit

Everyone speaks about the need for product market fit, which is fair and reasonable. As we dig deeper, the question on how to ensure product market fit when the product is already cast in stone?

Ideally, we would like to design a device that would be universally required and therefore have little trouble with this product market fit. In reality, this is always limited by the – yes, you guessed it – MARKET information in order to form the design inputs which is translated to product design.

Another key factor is TIME. Because, time is needed to design and develop a device, and by the time the device is fully validated, clinically evaluated, obtained regulatory approvals, time would have passed, and some markets may have changed.

What do we do in these situations? What do we actually do, to ensure product-market fit? It comes down to 2 key factors: who pays and how it fits into the workflow. While these are once again, cliché questions, they actually have answers.

Who pays depends on who CARES – the government? The patients themselves? The patient’s family? If someone cares, they will pay. If no one cares, then it will be a real challenge.

How does it fit into the workflow depends on the amount of benefit it gives each stakeholder. If it benefits one and detriments the rest, it will not help. For example, if the doctor gets results but it means 20% more workload for the nurses, you will meet strong resistance. The classic one is on AI software. Yes, faster results, but just not enough radiologist to sign off quickly enough.

The last factor is to learn how to admit it is not working in your desired market, and to re-direct your efforts quickly to markets that would work. Sometimes we may be over-patient, or sometimes it just take time. But assess your marketing burn and determine if it is to pull the plug and go somewhere else, or to put more efforts towards a DIFFERENT approach, and try again.

Good luck! If you are stuck you can always come to us!

 

Still clear as mud?
 
Contact Us ⟶
 
 
 
 
UPCOMING EVENTS
 
The holiday seasons are here, so get packing and visit some of these MedTech events!
 
 
The holiday seasons are here, so get packing and visit some of these MedTech events!
 
Latest Policy Updates & Medical Device Industry Dialogue
Penang, Malaysia
13 June 2024
Click Here ⟶
 
MedtecLIVE with T4M Stuttgart
Stuttgart, Germany
18 – 20 June 2024
Click Here ⟶
 
CPHI China
Shanghai New International Expo Center, China
19 - 21 June 2024
Click Here ⟶
 
Korea International Advanced Medical Equipment
& Medicine Expo 2024

EXCO, Daegu, South Korea
21 - 23 June 2024
Click Here ⟶
 
Clinical Trials Innovation Summit, Basel, Switzerland
Basel, Switzerland
25 June 2024
Click Here ⟶
The Regenerative Medicine Expo TOKYO
Tokyo Exhibition | Intex Osaka, Japan
26 - 28 June 2024
Click Here ⟶
 
NAAMA 33rd International Medical Convention, Egypt
Cairo, Egypt
27 June - 1st July 2024
Click Here ⟶
 
Meditech Bogota
Bogota, Colombia
9 - 12 July 2024
Click Here ⟶
 
US Annual Medical Device and Diagnostic Post-Market Surveillance and Vigilance Conference
Hilton Back Bay, Boston, USA
10 & 11 July 2024
Click Here ⟶
 
Asia Healthcare & Medical Cosmetology Expo 2024
Taipei, Taiwan
25 - 28 July 2024
Click Here ⟶
 
SPECIAL FEATURE
 
 
Asia Summit on Global Health 2024
 
Reimagining the Future of Healthcare: A Recap of the 2024 Asia Summit on Global Health
 
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The 4th annual Asia Summit on Global Health (ASGH 2024) convened experts in Hong Kong (May 16-17) to explore "Reimagining the Future of Healthcare." Over 90 international speakers addressed critical topics like leveraging technology, building sustainable systems, and emerging trends. The summit fostered collaboration through an exhibition and pitching sessions, driving positive change in Asia's healthcare landscape.

Read more about it in our blog post.
 
Click Here ⟶
 
 
 
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