MedTech Gateway
ISSUE 72

JANUARY 2025

Happy New Year – Onward 2025!

Fire and Ice dominated global headlines as we step into a brand-new year, recognizing the dynamic, polarizing nature of the Healthcare industry. In this edition of our newsletter, we are pleased to share various acquisitions in the device industry, healthcare policy changes, and regulatory framework developments.
Enjoy reading, and here’s to a successful and fulfilling year ahead!


REGULATORY ROUNDUP

THE LATEST REGULATORY UPDATES FOR THE
MEDICAL DEVICES INDUSTRY

UNITED STATES


Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products


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This guidance provides recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU).

Learn More ⟶

CHINA


The General Office of the National Medical Products Administration publicly solicits opinions on the "Medical Device Production Quality Management Standards (Revised Draft for Comments)"

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In order to further strengthen the supervision and management of medical devices, continuously standardize the production behavior of medical devices, and improve the quality management compliance capabilities and levels of enterprises, in accordance with the "Medical Device Supervision and Management Regulations" and "Medical Device Production Supervision and Management Measures", the State Drug Administration organized the drafting of the "Medical Device Production Quality Management Standards (Revised Draft for Comments)", and now solicits public opinions.
The public comment period is from January 16 to February 14, 2025. Relevant units and individuals can provide feedback to mdgmp@cfdi.org.cn . Please indicate "Medical Device Production Quality Management Standards-Opinions and Suggestions Feedback" in the subject of the email.  
Attachment:
1. Medical Device Production Quality Management Standards (Revised Draft for Comments).
Attachment 1.docx
2. Opinion and Suggestion Feedback Form Template
Attachment 2.docx  

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
  50. QMD Services GmbH – Austria - 2962
  51. NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) (Hungary) - 1011

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
  13. Istituto Superiore Di Sanita' (Italy) - 0373
  14. BSI Group The Netherlands B.V.(Netherlands) - 2797

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?

AUSTRALIA


$35.7 million to support clinical trials into areas of unmet medical need

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The 2024 Clinical Trial Enabling Infrastructure grant opportunity will provide $35.7 million for medical research and innovation projects that:
• address areas of unmet medical need through adaptive platform trials or registry-based randomised controlled trials
• strengthen the research sector’s capability and collaboration through new or expanded clinical trial practice networks.

Learn More ⟶

UNITED STATES


Changes in Patient Care Experience After Private Equity Acquisition of US Hospitals

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Private equity acquisitions of hospitals have increased over the past decade in the US.1, The growing presence of private equity in health care has been controversial, attracting widespread scrutiny from US congressional committees, health care leaders, and the public. This has been driven by concerns that private equity firms’ incentive to generate financial gains rapidly could have adverse implications for patient care.2-4

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EUROPE


New EU rules on Health Technology Assessment open up a new era for patient access to innovation

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On Sunday, 12 January, the Regulation on Health Technology Assessment (HTA) will become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU.

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INDUSTRY INSIGHT

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

UNITED STATES


Stryker announces definitive agreement to acquire Inari Medical, Inc., providing entry into high-growth peripheral vascular segment

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Stryker (NYSE: SYK), a global leader in medical technologies, announced today a definitive agreement to acquire all of the issued and outstanding shares of common stock of Inari Medical, Inc. (NASDAQ: NARI) for $80 per share in cash, representing a total fully diluted equity value of approximately $4.9 billion. Inari, which was founded in 2011, will bring a leading peripheral vascular position in the fast-growing segment of venous thromboembolism (VTE) to Stryker. Inari’s innovative product portfolio is highly complementary to Stryker’s Neurovascular business and includes mechanical thrombectomy solutions for peripheral vascular diseases such as deep vein thrombosis and pulmonary embolism.

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UNITED STATES


Vensana Capital Closes $425 Million Fund III to Back Breakthrough Medical Technology Companies

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Vensana Capital today announced the closing of Vensana Capital III with $425 million in committed capital. The fund was oversubscribed at its hard cap with the support of the firm’s existing limited partners alongside select new institutional investors, and it brings Vensana’s total capital under management to approximately $1 billion.

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JAPAN


Kaneka Acquires EndoStream Medical Ltd.

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Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Kazuhiko Fujii) acquired 96.8% of shares of EndoStream Medical Ltd. (Headquarters: Or Akiva, Israel; CEO: Danel Mayer; hereinafter referred to as ESM), an Israeli medical equipment company, on December 23,2024. By combining Kaneka's manufacturing and ESM's technology, we will jointly develop new medical devices, mainly for cerebrovascular treatment, in addition to the Nautilus™ device for aneurysm treatment currently under development. We aim to achieve sales of over 20 billion yen by 2030.

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PRODUCT COMMERCIALISATION

ARTICLES TO HELP YOUR JOURNEY IN COMMERCIALISATION

PROCESS FLOW


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QUALITY MANAGEMENT SYSTEM
Using GenAI for QMS?

Templates aplenty. eQMS getting more affordable
What is left to do? Customisation

However, the very nature of customization means that resources would need to be deployed to look into the procedures and determine which parts needs to be written specific for your organisation.
Is there some way that GenAI can help with this writing?
GenAI would need to have an information repository to form the context of this customization. This information repository would involve organisation, and product information. But what if these foundational information is not there? Then GenAI may try to interpolate according to what can be found publicly, and attempt to still have something ‘fairly customized’.
How about implementation? Developing the necessary competency? Using day to day, and to withstand a quality inspection? GenAI may or may not be able to answer these questions correctly, and if you implement a checkpoint, the review time may already be sufficiently substantial – might as well write it out directly!
GenAI can, however, be useful to populate templates. For example, validation protocols, where information is predictable. However, some clever documentation practices and nifty cut n paste, could just be as quick.
Perhaps GenAI can save a bit of time here and there, or allow a second look at something you feel you may have a jaded view. But nothing would be able to replace the human engagement to be competent in your organisation’s quality management system, to ensure good quality product is consistently produced, and improved.

Still clear as mud?

Contact Us Now! ⟶

UPCOMING EVENTS

The holiday seasons are here, so get packing and visit some of these MedTech events!
India International Healthcare And Medical Diagnostics Expo
Chandigarh, India
22- 24 Jan 2025
Click Here ⟶
 
13th Annual Outsourcing in Clinical Trials : Medical Devices Europe 2025
Munich, Germany
28 - 29 January 2025
Click Here ⟶
 
MEDIZIN Stuttgart
Stuttgart, Germany
31 Jan - 02 Feb 2025
Click Here ⟶
 
Health Expo Athens
Megaron Athens International Conference Centre, Greece
15 - 16 Feb 2025
Click Here ⟶
Medicall Kolkata
Biswa Bangla Mela Prangan Convention Centre, Kolkata
15 - 17 Feb 2025
Click Here ⟶
 
Medtrade East Dallas
Dallas, US
18 - 20 Feb 2025
Click Here ⟶

Saudi Hospital Design & Build Expo Riyadh
Riyadh, Saudi Arabia
24 - 27 Feb 2025
Click Here ⟶


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