It is the rainy season for most. Therefore Access-2-Healthcare is raining news to you in this issue of our newsletter! Other than a plethora of regulatory and country policy news, we will cover the recently concluded Medical Fair Asia 2023 in our special feature.


ISO 10993-17:2023 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

The first update of the #ISO10993-17:2023 in over 20 years has been completed and the new version has been published!

The updated standard describes a systematic approach to #toxicological #riskassessment, which includes identification of #hazards (a constituent that can cause harm relevant to the exposure scenario), and estimation of risk based on three factors: tolerable intake or tolerable contact level; worst-case estimated exposure dose #EEDmax and margin of safety #MOS.



Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission


In this draft guidance, FDA suggests four best practices to follow when choosing a predicate device to support a 510(k) application. Instead of concentrating on the predicate's age, these best practices take into account the characteristics of the predicate devices.


Three new UK Approved Bodies brings a lot of expectations to medical businesses

The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, supporting faster certification of safe and effective medical devices for healthcare professionals and the public. From this issue onwards we will start tracking the UKCA Approved Conformity Assessment Bodies. Just scroll on!



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.  HT Cert (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

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


UK approved bodies


Government of Timor-Leste, the Japanese Government and UNICEF join hands to improve health of adolescent girls

In Timor-Leste 32 percent of girls 14-19 years suffer from anemia, triggered mostly because of the physiological and emotional changes of their bodies, which require additional nutrients. In a joint move to enhance the health and wellbeing of adolescent girls in Timor-Leste, the Government of Timor-Leste today received 8.000.000 Iron and Folic Acid (IFA) tablets, from the Government of Japan in partnership with the United Nations Children’s Fund, (UNICEF).


The AMA has told a parliamentary inquiry the introduction of a sugar tax and a much stronger focus on prevention and addressing inequities in the health system could mitigate the $3.1 billion cost of diabetes in Australia.


12th ASEAN Device Commitee (AMDC) meeting & It's related events

The 12th ASEAN Medical Device Technical Committee (AMDTC) meeting chaired by Thailand, while the 12th ASEAN Medical Device Committee (AMDC) meeting chaired by Brunei was held in Bandar Seri Begawan, Brunei Darussalam.
In this annual meeting, topics such as "Updates on Recent Developments on Economic Integration Initiatives in ASEAN," "Report from AMDTC," "Updates on the Implementation of ASEAN Medical Device Directive," "Technical assistance and Cooperation with Dialogue Partners," ...



Need for comprehensive structural reforms of the medical technology regulatory frameworks

Together with 34 national associations, MedTech Europe has sent an open letter to Commissioner for Health, Stella Kyriakides, regarding the need for comprehensive structural reform in the European regulatory framework for medical technologies (IVDR and MDR).



First device to monitor transplanted organs detects early signs of rejection

A tiny sensor that even makes a fingertip look large has the potential to be a game changer for detecting signs of rejection in kidney transplants. Scientists from Northwestern University have successfully created a device, tested on mice, that can detect warning signs of kidney rejection up to three weeks before current monitoring methods.



A smart gas-sensing capsule invented in Australia could soon help people living with bowel syndromes

Doctors could soon use the smart Atmo Gas Capsule to diagnose and treat bowel syndromes, replacing invasive or hard to interpret methods. The Australian company Atmo Biosciences is developing and marketing this new device.

Process flow

Paper or Electronic?
That is the (QMS) question

Are you struggling with QMS templates, can’t get them to fit perfectly into your organization?
Do you feel frustrated with the countless times you had to wait for a document to open in an electronic QMS (eQMS)?
Are you struggling with getting signatures to approve one document change?
Do you feel frustrated with the countless steps before you can approve one action
Therein lies the conflict of paper vs eQMS.
Which is better?

That leads to the old adage ‘it depends’.
OK, what does it depend on?
Organizational structure (not size) Is everyone in the same building, or in different buildings, or at home, or in different countries.
In ascending order, this goes towards online document review and approvals, to avoid chasing signatures (there are many e-signature software and modules to plug in).
Frequency of product changes Most QMSs don’t change, however if the product portfolio increases, vs. increments of the same product, the former favors eQMS, the latter a paper one. Because it depends on how configurable is the eQMS and how much time is needed to do so. People in touch with the QMS The less people in touch, the better the eQMS would positively impact the organization. This is because there will be a few key users to train and that may help to ensure the eQMS is effectively used. The more people are in touch, the better it is to stick with paper QMS.
However, it depends on the organization structure (see above).
What is important is to ask these key questions before determining which is better. Of course, in both cases, some help may be required to implement, upskill the organization, and get it ready for the eventual audit to pass.

Still clear as mud? Contact us.

Medical Fair Thailand 2023ết_kế_chưa_có_tên.png

Reimagining the marketplace amidst a changing landscape, the 10th edition of MEDICAL FAIR THAILAND was held between 13-15 September 2023 and continues to be Thailand’s leading medical and healthcare exhibition and industry sourcing platform.

25,000+ International visitors from 80 Countries & Regions, 800+ Exhibitors from 40 Countries & Regions, and 22 National & Group Pavilions. BITEC’s great facilities allowed the exhibitors to be all house in one exhibition and gives the vibe of MedTech marketplace.

Access-2-Healthcare was actively engaging with partners both current and potential and had a blast. Read more about it in this blog post.

Autumn leaves don't fall; they fly. Let's head to new events!

BIOMEDevice Boston 2023

September 20-21, 2023

Boston, Massachusetts, United States

Medical Fair Brasil Sao Paulo
26. - 28. September 2023
Buenos Aires, Argentina

Public Health Kiev
04. - 06. October 2023
Kiev, Ukraine

Medic West Africa Lagos
11. - 13. October 2023
Lagos, Nigeria

Dental World Budapest

12. - 14. October 2023

Budapest, Hungary

Our mailing address is:

Want to change how you receive these emails?

you can update your preferences or unsubscribe from this list.