Halfway point

Summer Solstice, the longest day of the year is soon here for the Northern hemisphere. It has been marked by festivals and rituals throughout the world since prehistory. This month’s MedTech Gateway from Access-2-Healthcare will send you into the latter half of the year, full of advances in medical device technology.


The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26 May 2023. Guidance on the transition to new manufacturer evidence for IVD medical devices will be published soon.

Phase out of ISO 13485 certificates for IVD medical devices



Guidelines for entering application documents for classification and definition of medical devices (draft) released is

The Center for Medical Device Standardization Administration (NPMA) has released guidelines for entering application documents for classification and definition of domestic and foreign medical device products.


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


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.  ICIM S.P.A (Italy) – 0425

18.  IMQ (Italy) – 0051

19.  Institut Pro Testovani A Certifikaci (Czech Republic - 1023

20.  Intertek Medical Notified Body AB (Sweden) – 2862

21.  Istituto Superiore Di Sanita’ (Italy) – 0373

22.  ITALCERT SRL (Italy) – 0426

23.  KIWA CERMET ITALIA S.P.A (Italy) – 0476

24.  Kiwa Dare B.V (Netherlands) – 1912

25.  MDC Medical Device Certification (Germany) – 0483

26.  NSAI (Ireland) – 0050

27.  Polskie Centrum Badan I (Poland) - 1424

28.  SGS Belgium NV (Belgium) – 1639

29.  SGS FIMKO OY (Finland) – 0598

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

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

1.  3EC International (Slovakia) – 2265 

2.  BSI (Netherlands) – 2797

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 



1.  BSI Assurance (UK) – 0086

2.  DQS Polska (Poland) – 2282

3.  ECM (Germany) – 0481

4.  GMED SAS (France) – 0459

5.  Presafe (Denmark) – 0543

6.  SGS United Kingdom Limited (UK) – 0120


NEC Thailand to build digital health platform for supporting elderly and patient care

NEC Corporation (Thailand) Ltd. (NEC Thailand), has signed a Memorandum of Understanding (MoU) with Chiang Mai Municipality to develop smart city solutions and transform Chiang Mai into a smart city, starting with a digital platform for the district’s healthcare system. The system will support healthcare facilities in Chiang Mai that are housing the elderly and chronically-ill patients. The MoU will also explore the feasibility of utilizing other applications within the community under the “Smart Hospital” theme.



Medical Radionuclide Innovation Programme

Under the Department for Energy Security and Net Zero, this Programme will support development of technologies that may enable future access to medical radionuclides. The Innovation Project Workstream is now open for applications.



Scivita Medical’s Headquarters, R&D and Manufacturing Plant Officially Opened

Scivita Medical’s headquarters, R&D and manufacturing plant was officially opened in Suzhou Industrial Park (SIP). This momentous occasion marks a significant milestone for Scivita Medical as it consolidates its key operations, encompassing R&D, production, marketing, doctor training, product display, and experiential activities. The establishment of the plant will serve as a strong foundation for Scivita Medical to enhance its R&D capabilities as well as sales capabilities, further upgrade its production capacity and improve product competitiveness. It reflects Scivita Medical's commitment to its core strategy of “globalisation”


Korea-Sweden partnership to address radiologist shortage with AI-powered mammography analysis Lunit, a leading global provider of AI-powered cancer diagnostic solutions, today announced the signing of a supply and license agreement with Capio S:t Göran Hospital (Stockholm), Sweden’s largest private hospital with over 2,300 medical staff. Under the agreement, Lunit will provide S:t Göran Hospital with Lunit INSIGHT MMG, an AI solution for mammography analysis, for the next three years.

Process flow

Ideas vs Concepts, Mockups vs Prototypes

When we have contact with the researchers or doctors that have the next big idea in MedTech, sometimes the word ‘idea’ and ‘concept’ may be used interchangeably. In truth, is there any difference between them?

Idea – could be seen as a hypothesis that’s not yet user validated. It could be some thoughts being put together and presented as a possible solution. A concept is considered a structured solution where the clinical workflow and it needs to be user validated for the development work to continue. This is quite similar to the difference between a “mockup" and a "prototype” – where a mockup is putting together some existing items or components to create the proposed solution, and the prototype comes from creating parts or modules (that are not verified or minimally verified) from technical drawings or software architecture.

Why it is important to distinguish between them?
It is important to determine when the appropriate moment is to proceed towards proof of concept – which is to validate the value of the proposed solution. It is also a point to determine when the appropriate method is to request for funding. Ideas and mockups are usually too early, whilst concepts and prototypes especially after 1 iteration may be suitable for seed funding.

Although summer holidays are coming, get ready for the second half of the year with these MedTech events!

Medtech Summit

June 17-23

Brussels, Belgium (onsite and online)

FIME 2023 Medical Device and Equipment Exhibition

June 21-23, 2023

Miami, FA (onsite and online)

Medical Device Development Expo MEDIX

June 21-23, 2023

Tokyo, Japan

Medical Show Japan and Business Expo 2023

June 29-July 1, 2023

Yokohama, Japan

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