MedTech Gateway
ISSUE 67

AUGUST 2024

Europe’s out for the holidays (and after the Olympics), Asia Pac’s in vogue now – business wise. We have a fairly balanced edition of our MedTech Insights to provide updates on regulations, healthcare policies, and medical technology, to enable further enrichment of your perspective on access to Healthcare. Enjoy!


REGULATORY ROUNDUP

THE LATEST REGULATORY UPDATES FOR THE
MEDICAL DEVICES INDUSTRY

SWITZERLAND


swissdamed – swiss database on medical device

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The first module of the swissdamed medical devices database is live swissdamed is the new Swissmedic database for registering economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market. The first of two modules went online on 6 August.

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EUROPEAN UNION


New pilot programme to support orphan medical devices

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EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation. While the pilot programme is currently scheduled to run until the end of 2025, the aim is to establish a long-term process for orphan device support.

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AUSTRALIA


Medical devices affected by 3G network closure – Really? 3G?

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Some medical device equipment, as well as products such as personal medical alarms could be affected as mobile network operators prepare to switch off their 3G networks- external site. 3G has been in use since the early 2000s but is being decommissioned in place of the advanced 4G and 5G networks.

Telstra and Optus will switch off their third-generation mobile networks at the end of August, while TPG Telecom/Vodafone already did so at the start of 2024.

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BRAZIL


CMED launches form for receiving complaints

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Starting this Thursday, August 1st, reports of violations related to the pharmaceutical market can be sent through a new online form , accessible to all citizens and interested bodies. The measure aims to improve the process of receiving and analyzing complaints and reduce the response time to citizens. The initiative is part of the strategies of the Chamber for the Regulation of the Medication Market (CMED) to strengthen the monitoring of this market in our country.

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?

CANADA


Better dental care - Nearly 450,000 eligible Canadians have received care under the Canadian Dental Care Plan

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The Canadian Dental Care Plan (CDCP) is one of the largest social programs in Canadian history. Once fully implemented, the CDCP will help make dental care more affordable for up to nine million Canadian residents who do not currently have access to dental insurance.

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PHILIPPINES


Lawmaker calls for another 30% increase in PhilHealth benefits

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A House of Representatives resolution is urging the Philippine Health Insurance Corporation (PhilHealth) to implement another round of 30-percent increase in all its benefit packages and coverage.

House Resolution No.1900, filed by Agri Party-List Rep. Wilbert Lee, seeks to determine how PhilHealth can expeditiously increase the current benefits and introduce new benefit packages such as the inclusion of vital diagnostic tests and other essential laboratory exams as outpatient services.

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KOREA


Korea and ASEAN Adopt Joint Statement to Strengthen Regional Health Cooperation through Digital Health

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Minister Cho Kyoo Hong of the Ministry of Health and Welfare (MOHW) attended the 2nd Korea-ASEAN Health Ministers Meeting and the 10th ASEAN Plus Three (Korea, Japan, China) Health Ministers Meeting on Friday, August 9, in Vientiane, Lao PDR. At these consecutive meetings, he discussed strategies for cooperation to enhance regional health security and promote health through digital health initiatives.

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INDUSTRY INSIGHT

ANNOUNCEMENTS FROM COUNTRIES WHERE WE HAVE A PRESENCE

UNITED STATES


Neuronetics and Greenbrook TMS Announce Definitive Agreement to Merge

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Neuronetics, Inc. (NASDAQ: STIM) (“Neuronetics”) and Greenbrook TMS Inc. (OTCMKTS: GBNHF) (“Greenbrook”) today announced that they have entered into a definitive arrangement agreement (the “Definitive Agreement”) in which Neuronetics will acquire all of the outstanding common shares of Greenbrook in an all-stock transaction.

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UNITED STATES


Eyedaptic to unveil new AI-powered EYE6 smart glasses

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Eyedaptic has announced the unveiling of its new smart glasses that harness the power of artificial intelligence (AI) in order to visually assist those with age-related macular degeneration and other retinal disorders that cause vision loss.1 EYE6, which is coupled with Eyedaptic’s interactive visual assistant named Ivy, will be introduced at the American Retina Forum National Meeting on August 7 in Carlsbad, California, according to a news release.

Learn More ⟶

PRODUCT COMMERCIALISATION

ARTICLES TO HELP YOUR JOURNEY IN COMMERCIALISATION

Finding Distribution Channels


When distribution channels are needed; When not

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Sales distribution channels are always needed, it’s just that they are not necessarily distributor channels.

What we always want a distributor to have are:

  1. Clinical network, which leads to sales.
  2. Human resources - for business development, sales pitching, and follow up
  3. Market entry, logistics – a party that will absorb the costs of these activities

However, the most important factor that a distributor needs to have is : commitment.

Without commitment,

  1. Product knowledge cannot be acquired due to lack of time, human resources allocated.
  2. Business development efforts may not be as comprehensive
  3. Follow up may be slow, to a point where the lead turns cold
  4. Market entry efforts may be slow

It most cases, Commitment isn’t easy to come by when the distributor

  1. Finds your product ‘interesting’ and ‘let’s give it a go’
  2. Does not provide a clear go-to-market strategy, and intends to just ‘integrate with our current offerings’
  3. Has similar products to yours

Can we do without a distributor?

You can do without a distributor, but you cannot do without sales distribution. To build these channels, commitment from the manufacturer is the most important factor – to be present in the market before the product gains market entry, building awareness, and gaining more knowledge about the market dynamics in the country.

There are situations where a distributor would really be needed. Not just their existing network, but their technical service support, or storage space. But even that, there may be ways around it. Email us to find out how.

 

Still clear as mud?

Contact Us Now! ⟶

UPCOMING EVENTS

The holiday seasons are here, so get packing and visit some of these MedTech events!
MEDCARE Leipzig
Congress Center Leipzig, Germany
03 - 04 September 2024
Click Here ⟶
 
Clinical Trials in Rare Diseases
San Francisco, CA, US
10 - 11 Sept 2024
Click Here ⟶
 
MEDICAL FAIR ASIA
Marina Bay Sands, Singapore
11 - 13 Sept 2024
Click Here ⟶
 
BIOHK Hong Kong
Hongkong, China
11 - 14 September 2024
Click Here ⟶
 
UzMedExpo Tashkent
Uzbekistan
18 - 20 September 2024
Click Here ⟶
 
MedTech World
Singapore
17 Sep 2024
Click Here ⟶

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