Hurray for Warmer Weather!

May is considered as Mental Health Awareness Month. Throughout the world, people from every background, both the young and old, are affected. Towards the end of the month, Memorial Day is celebrated in the United States, which also means summer is soon! Here is this month’s MedTech Gateway from Access-2-Healthcare to help keep you up-to-date with medical device technology.


The Medicines and Healthcare products Regulatory Agency (MHRA) has updated file 'Medical device stand-alone software including apps' which has information on when software applications are considered to be a medical device and how they are regulated. It now includes information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.

Medical devices software applications guidelines update



Decisions of 57th Meeting of Medical Device Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 57th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers.



On Monday, February 20, 2023, given the impact of COVID-19, the conference was held online about the 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning in Japan.

The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning


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


HMI Group and MHC join forces to deliver seamless patient journeys and better health outcomes through technology

Health Management International Pte Ltd (“HMI Group”), a regional healthcare provider, has entered into an agreement to fully acquire MHC Asia Group Pte Ltd (“MHC”), a leading medical benefits administrator and healthcare technology platform in Singapore. This will place the HMI Group in a better position to address some of the key challenges that Singapore’s healthcare sector is expected to face over the coming years, including a rapidly ageing population, rising healthcare costs and a growing prevalence of chronic diseases.



Countries launch programs and services to guide the healthcare sector

In the UK, the NHS AI Lab in NHS England has funded the creation of a central source of regulatory and best practice guidance related to AI and digital technology in health and social care, Down in Australia, applications are now open for CSIRO’s 10-week Innovate to Grow program, which provides small and medium enterprises (SMEs) with the knowledge and tools to better identify and understand their R&D opportunities in the health and medtech sector.



Korea-U.S. High-Tech Alliance to Set Global Standards

On the occasion of the state visit of President Yoon Suk Yeol, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) met with Dr. Robert M. Califf, Commissioner of the US Food and Drug Administration (FDA) to discuss cooperation between the two organizations in the field of digital health and signed a Memorandum of Cooperation (MOC*) to strengthen cooperation on medical products using artificial intelligence (AI).

Process flow

Post Market Considerations

_ Capital equipment vs consumables _

When the product reaches the customer, this is when the actual access to healthcare begins. There are the various after-market considerations any manufacturer or distributor needs to have. The two main groups of medical devices are capital equipment and consumables. The approach to after-market is very different.

Consumables are concerned about the continued availability, at times its sterility, and the appropriate disposal of them. Capital equipment (not restricted to large equipment, small equipment or software is considered the same) would have to consider device training, maintenance and servicing, and device upgrading.

But both classes would have some similar needs, such as the regulatory considerations (product feedback and complaints, adverse events) just that it its disposition may also be different.

For example, the way to deal with consumables for product recall may include appropriate disposal, but in capital equipment it may involve either returning to the manufacturer, exchange, or on-site repair. Either case, the logistical considerations are very significant.

A manufacturers and distributors’ resources would need to adjust accordingly. For example, service staff for capital equipment.

Sometimes this may be remote (e.g., for software as a device, or well-designed capital equipment that can be serviced remotely) Some distributors may have capital equipment that requires consumables as well, and they would have their hands full!

Enjoy the lovely weather and start traveling to these MedTech events to open up new horizons.


June 7-10, 2023

Cairo, Egypt


June 8-10, 2023

Taipei, Taiwan (online/physical)

MD&M (Medical Design & Manufacturing) East 2023

June 13-15, 2023

New York, NY


June 07-07, 2023


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