MedTech Gateway
ISSUE 71

DECEMBER 2024

Dear Valued Clients and Partners,

As we embrace December, the final chapter of a year marked by transformation, we at Access-2-Healthcare are delighted to connect with you. Hope everyone closes the year on a high.

We sincerely appreciate the trust and partnership you have shown us, not just in the past year but these 9 years. With our 10th year approaching, let’s continue to drive innovation, achieve success, and make meaningful progress in the field of medical devices as we close this year and look forward to the future.


REGULATORY ROUNDUP

THE LATEST REGULATORY UPDATES FOR THE
MEDICAL DEVICES INDUSTRY

UNITED STATES


Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions


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FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.

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BRAZIL


Anvisa clarifies the import of medical device components

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Anvisa has updated its understanding of the Operating Authorization for storage facilities in special warehouses and importers of medical device components. The measure applies to finished products subject to regularization by the Agency, resulting from the recent publication of Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024.

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MALAYSIA


MeDC@St3.0 Project Development Timeline: Advancing Malaysia's Medical Device Regulatory Framework


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The Medical Device Authority (MDA) of Malaysia has released the development timeline for the MeDC@St3.0 project, spanning from 2023 to 2027. This ambitious initiative aims to enhance the country’s medical device regulatory framework, reaffirming MDA’s commitment to ensuring the safety and efficacy of medical devices in Malaysia. The timeline outlines key milestones and phases, offering stakeholders a clear roadmap of the project’s progression and upcoming developments.
In Q4-2024, the project has reached a significant phase, featuring the presentation of its progress and the finalization of the Business Requirement Specifications (BRS) based on the collected input.

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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?

EUROPE


Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation

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Regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostics aim to ensure the availability of safe and effective devices. This should protect patient safety and public health while making the sector more competitive and supporting innovation.

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UNITED KINGDOM


Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today

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New legislation is being laid in Parliament today that will address the research sector’s need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. It will make the UK a more attractive place for innovators to conduct important research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible.

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INDUSTRY INSIGHT

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

UNITED STATES


Landmark Lumbar Total Disc Replacement Study of Nearly 1,200 Patients Supports Long-term Clinical Success and Durability of Centinel Spine’s prodisc® L System

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Centinel Spine®, LLC (“the Company”), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced the recent release of a landmark study supporting the long-term clinical success and durability of its prodisc L Lumbar Total Disc Replacement (LTDR) technology.1 The study has been posted electronically prior to print publication by The Journal of Bone & Joint Surgery, considered the gold-standard in peer-reviewed orthopedic scientific information.

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SINGAPORE


CBC Group R-Bridge Healthcare Fund Announces up to US$50 Million Financing for Human Investments Ltd. to Fund Motiva® Market Expansion

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R-Bridge Healthcare Fund (“R-Bridge”), an affiliate of CBC Group, Asia's largest healthcare-dedicated asset management firm, today announced the closing of a non-dilutive growth financing facility of up to US$50 million for Human Investments Ltd.

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THAILAND


Dr. Ekoshi of “Nihonjoju Clinic” promotes innovation of 'rejuvenating health from cells' with NMN nutrients and exosomes, and brings Japanese standard medical beauty to Thai people.

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With many health and beauty problems in today's society being caused by aging and cell deterioration, Nihon Joju Clinic was born, a clinic that operates under the concept of "rejuvenating health from cells", using the latest medical technology for treatment. Recently, Dr. Egoshi is preparing to fly to Thailand to promote new innovations with advanced technology to Thais who care about their health and beauty.

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UNITED KINGDOM


Researchers discover new third class of magnetism that could transform digital devices

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A new class of magnetism called alter magnetism has been imaged for the first time in a new study. The findings could lead to the development of new magnetic memory devices with the potential to increase operation speeds of up to a thousand times.

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PRODUCT COMMERCIALISATION

ARTICLES TO HELP YOUR JOURNEY IN COMMERCIALISATION

Prototyping Considerations


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The crux of prototyping is broken down to two key aspects

- Ability to understand and translate clinical need
- Engineering capability

To understand and translate Clinical Need does more than just satisfying the clinician or the patient. It helps to reduce iterations, and therefore reduces time and effort wastage. By listening and considering feedback, a better form factor, better device usability are likely outcomes.
Engineering capability is based on the ability to have 1. Engineering tools and equipment. 2. Actual engineers that knows how to operate the tools, and engineering design skills.
Between the two, having engineering capabilities appears to be less of an issue, but it can be when the engineers are good in one aspect of engineering and therefore one part of the device, but not too good with others. Furthermore, the ‘capabilities’ here refer to the engineering resources in touch with you, not their suppliers.
A recent case is exactly, that, where the client is endlessly waiting for a (competent) supplier of the engineering company that was contracted, because of the lack of commitment from the supplier. What would be done in 3 months had stretched to 8 months. Does it matter? Yes! Because in the other 5 months you are eating up cash in other aspects. So speed indeed is the essence.

Therefore, some of the first checks to hunt for the right prototyping group
- If they are listening to you and considering your feedback, even when you don’t appear to make sense.
- Have the necessary engineering tools
- Ensure engineers are capable and not just their suppliers
- Commitment to your project, or else the project will drag on endlessly.

Still clear as mud?

Contact Us Now! ⟶

UPCOMING EVENTS

The holiday seasons are here, so get packing and visit some of these MedTech events!
Duphat Dubai
Dubai World Trade Center, Dubai
07 - 09 January 2025
Click Here ⟶
 
Hong Kong Baby Products Fair
Expo Galleria, Hong Kong Convention and Exhibition Centre, Wan Chai, Hong Kong
6 - 9 January 2025
Click Here ⟶
 
Pharmatech Expo 2025 – Bengaluru
Bengaluru, India
8 - 10 January 2025
Click Here ⟶
 
ESTHEC JAPAN Tokyo
Tokyo, Japan
15 - 17 January 2025
Click Here ⟶
 
Pak Pharma & Healthcare Expo Lahore
Expo Centre Lahore, Pakistan
20 - 22 January 2025
Click Here ⟶
Lääkäripäivät Helsinki
Helsinki, Findland
22 - 24 January 2025
Click Here ⟶
 
Wearable Expo
Tokyo, Japan
22 - 24 January 2025
Click Here ⟶

22nd Annual Medical Expo
Floria, USA
25 January 2025
Click Here ⟶

Arab Health Dubai
Dubai World Trade Centre, Dubai
27 - 30 January 20255
Click Here ⟶
 

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