The view of Sakura in full bloom – a beautiful sight – just along a narrow street in the city. Just when our minds are on the fragility of things (see below story on SVB), something great can happen or be created anywhere. Here is this month’s MedTech Gateway from Access-2-Healthcare to help you find your next step.


Vietnam Amends on Medical Device Management

The Government issued Decree No 07/2023/NĐ-CP on 03 Mar 2023, amending and supplementing a number of articles of Decree No 98/2021/NĐ-CP to remove problems with current medical equipment management.



The Health Sciences Authority has issued a revision to GN-21: Guidance on Change Notification for Registered Medical Devices.

Revision to GN-21: Guidance on Change Notification for Registered Medical Devices



Council takes action to mitigate risk of medical devices shortage

The Council of the European Union has adopted the Commission's proposal to give notified bodies and manufacturers more time to certify medical devices and thereby mitigate the risk of shortages. This follows the positive vote by the European Parliament last month. The legislative proposal provides a longer transition period to adapt to new rules foreseen under the Medical Devices Regulation, ensuring continued access to medical devices for patients in need. Learn more from the following links:



The Directorate General of Health Services of the Ministry of Health & Family Welfare in India has released lists of notified bodies registered with CDSCO under MDR, 2017 and medical devices testing laboratory for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017. Learn more from the following links:


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.  TUV NORD Polska (Poland) – NB 2274

33.  TÜV NORD CERT GmbH (Germany) – 0044

34.  TÜV Rheinland Italia SRL (Italy) – 1936

35.  TÜV Rheinland LGA (Germany) – 0197

36.  TÜV SÜD (Germany) – 0123

37.  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[NH1] 

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


FDA Seeks $7.2 Billion to Protect and Advance Public Health by Enhancing Food Safety and Advancing Medical Product Availability

The U.S. Food and Drug Administration announced it is requesting $7.2 billion as part of the president’s fiscal year (FY) 2024 budget. This funding will allow the agency to continue to leverage new and emerging technologies, recruit and support a highly skilled workforce and adapt oversight to new production and business models. This is work that will have an immediate impact on food, tobacco and medical product safety in the U.S. while also preparing the agency to address rapid innovation across the food and medical products fields.



Round 3 Artificial Intelligence (AI) in Health and Care Awards

The Artificial Intelligence (AI) in Health and Care Award is an NHS AI Lab programme run by the Accelerated Access Collaborative (AAC) in partnership with the National Institute for Health Research (NIHR). It provides funds for the testing and evaluation of the most promising AI technologies which meet the strategic aims set out in the NHS Long Term Plan. The winners of the third competition were announced by Secretary of State for Health and Social Care, Steve Barclay, on 3 March 2023. Check out the winners from the following link and also more about two of the winners, Ibex with their AI-powered breast cancer diagnostics and icometris with AI applied to magnetic resonance imaging (MRI) in the care of patients with multiple sclerosis.  Learn more from the following links:


SiYi Intelligence Raises Nearly $15 Million in Series A Financing

SiYi Intelligence, an intelligent rehabilitation solution provider established in 2017, completed nearly 15 million US dollars in Series A financing. This round was led by Chengdu Bio-town Equity Investment Fund with participation from existing investor Tao Capital. The company plans to use the funding to accelerate the R&D of integration solutions for neurorehabilitation and build the digital rehabilitation service platform.


Implantica Announces RefluxStop Launch in Spain

Implantica AG (publ), a MedTech company at the forefront of bringing advanced technology into the body, announces today that the first two RefluxStop™ procedures to treat acid reflux have been performed at the Hospital Universitario Getafe in Spain


New ultrasound method could lead to easier disease diagnosis

A new ultrasound method that can measure the level of tension in human tissue for the first time - a key indicator of disease - has been developed by researchers from the University of Sheffield.


Chinese University of Hong Kong (CUHK) performs world’s first robotic-assisted bronchoscopic microwave ablation of lung metastases

The Chinese University of Hong Kong (CUHK)’s Faculty of Medicine (CU Medicine) performed the world’s first robotic-assisted bronchoscopic microwave ablation of lung metastases. This non-invasive procedure does not involve removal of healthy lung tissue and is now in clinical trial with a target of enrolling up to 145 patients worldwide.


With the recent collapses of Silicon Valley Bank, Signature Bank, how does that affect the MedTech Industry?

Silicon Valley Bank was shuttered Friday, leading to a tense weekend for many tech companies, including some in medtech.

Process flow

Regulatory Approvals

- Planning before doing, but don’t forget to do! -

While many people may stress on the importance of a regulatory strategy in the medical device industry – be it for investment, for new product launch, for a go to market strategy – one key area of planning is the regulatory pathway.

What is a regulatory pathway? It is the selection of the path in which the medical device would be stepping through based on the least path of resistance, as well as the longer-term considerations. Key considerations are on what the medical device already has:
- Previous regulatory approvals
- Completeness of technical file
- Clinical studies, in various countries Usually, a country’s regulatory framework will have various pathways. The selection of pathways depends on the above factors, as well as the ability to meet the conditions of these various pathways.

Some regulatory frameworks depend on the predicate device (Taiwan, Korea, US), where it would mean that the product category can be found and thus the device classification. Some regulatory frameworks leverage on the device nomenclature (GMDN, UMDN, JMDN etc.).

Some regulatory frameworks have existing lists in which the medical device will fit into the existing product in these lists. That in turn determines the device classification. Some regulatory frameworks focus on other regulatory approvals that had been previously obtained. This is the main reason why so many companies started with the CE marking or US FDA approvals, before using them to leverage other markets’ regulatory approvals. Lastly, there are the rule-based (e.g. CE marking), or possibility to determine new categories (US de novo process).

One final advice is – do not fall head over heels over the ‘innovative pathway’. This pathway is meant for the ones that are really not falling into any product category and have no previous regulatory approvals. The teams in the competent authority are relatively small (because there are, in theory, not as many innovative products), but if medical device companies all wanted to go through a potentially faster pathway and claim that their device is innovative, be prepared to get into a traffic jam. Perhaps it is just faster to go through the normal pathway!

Just let us know if you face any pathway challenges, we are here to help!

With the start of Spring, it is the right time to travel to new places and expand your network. Here are some places to start your journey.

KRAKDENT 2023 -International Dental Trade Fair in Krakow

March 30-April 1, 2023

Krakow, Poland

AORN 2023 – Global Surgical Conference & Expo

April 1-4, 2023

San Antonio, TX

Medtec Japan

April 19-21, 2023

Tokyo, Japan

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