Activity report (2023) and activity policy (2024) by committee chairperson

The chairman、Mr. Mori.
Thank you very much for taking time out of your busy schedule to attend the Medical Devices
and IVD Committee Representative Meeting today.
The year 2023 marks the end of the coronavirus pandemic, but it was a very difficult year withvarious issues remaining. All kinds of costs, including material costs, logistics costs, utility
costs, and labor costs, were soaring, and it was also difficult to pass on the costs to thecustomers, and with the weak yen taking its toll, it was not easy to continue the business.
The 2023 activity summary you are viewing is a list of the EBC's advocacy and activities invarious situations over the past year.
Now, medical DX has been a hot topic for the past year or so, and it was thought that it could

be a bright future, but the current situation is that it is not making much progress.
We believe that increasing productivity in the medical field will lead to lower medical costs,and for this purpose, there is value in testing, diagnosis, and treatment, and correct evaluation,such as reducing patient waiting time and assisting doctors in diagnosis and treatment, etc.
We are continuing our activities to request evaluations.
As an example of this, we have been introducing the German DiGA program to the Japanese
government related over the past few years, and it has now become widely known to allconcerned parties, and is used as a reference when considering insurance for programmed
medical devices.
This achievement is the result of the hard work of all members of the Digital Health TaskForce. thank you very much.
In addition, as a basic activity, we are continually discussing various issues with the Medical
Device Review Management Division and PMDA regarding optimization and speeding up
reviews.
Programming medical devices was a big challenge. As for the approval system, we were able
to achieve great results by issuing notifications for DASH for SaMD2 and establishing a twostep approval system.
Regarding IVD, there are still discrepancies in the review requirements and standards at thePMDA, and we are currently in the process of steady discussions regarding their improvement,
including the review of review categories for pathogen genetic testing.
Regarding medical fees, I feel that further discussion is necessary regarding unprofitability
related to stable supply and foreign price adjustment, and that challenge applications that cansecure time for research planning should also be discussed.
Regarding the state of insurance related to the two-step approval of programmed medicaldevices, we are proposing the concept of combined treatment not covered by insurance. Thisis a challenge that must be discussed with the Ministry of Health, Labor and Welfare andinsurance unions, which want to maintain universal health insurance at all costs, but it is also
true that everyone involved feels that universal health insurance will collapse if things
continue as they are.
It may be time to consider the use of Combined treatment not covered by insurance as ameasure to protect universal health insurance.
As I said at the beginning, it was a very difficult year. I would like to express my gratitude to
the members of the committee who took time out of their busy schedules to participate indiscussions with industry and government to achieve results.
Thank you very much. ⇒ Next page 2024 Activity policy

Now, regarding the issues that we must tackle in fiscal 2024, as you can see, we must continue
to address many of them.
The most recent issue is cybersecurity. As reported in the Nikkei Shimbun newspaper last
Saturday, there has been a general agreement in Europe to require all products connected tothe Internet to have cybersecurity measures. We have also been closely monitoring the coming
into force of the Cybersecurity Act in 2019 and the EU Cyber Resilience Act in 2022
(currently excluding medical devices).
As you know, in Japan, "Article 12, Paragraph 3 of the Basic Requirements Standards forMedical Devices" was newly established in 2023. Requirements for cybersecurity measures
are presented to each company and they are required to apply them. It will be applied from
April 1, 2024, and I think each company is preparing. However, as confusion is expected after
implementation, the committee believes that it is necessary to provide support to member
companies.
We would also like to promote the secondary use of RWD (real world data)/RWE (real worldevidence), registry data, etc. used in examinations by companies.
Although the handling of personal information has been relaxed in Japan under the Next
Generation Medical Infrastructure Act, progress is still slow. In the United States, the numberof implementation cases is increasing due to FDA guidance, and in Europe, laws andregulations are being developed with the aim of secondary use by companies by 2025. As longas Japanese data is requested, I would like to work to ensure that it can be utilized domesticallyas soon as possible.
The most important thing about IVD is that it will be independent from the drug classificationin the next revision of the Pharmaceutical Machinery Act. It's a huge challenge, but I hopethat this year will serve as a guidepost for moving forward.
We will promote transparency and simplification of the examination process and international
harmonization of examination requirements, etc., with the aim of reducing the burden on
both government and industry and improving productivity.
Regarding medical fees, future insurance systems may need to be significantly reviewed
depending on how we can show the path to combined treatment not covered by insurance.
The discussion of universal health insurance and non-insurance coverage can be said to be amajor initiative for next year.
Based on the experience of COVID-19, the ``Revision of the Infectious Diseases Law'' thatincorporates logistics issues in 2024 has been under discussion since last year. I have heardthat it includes quite a few demands for companies.
The committee will also respond appropriately.
We will continue to work on a wide variety of issues in 2024. We appreciate your continued
understanding and support.
Once again, thank you very much for taking time out of your busy schedule to join us today.
We would also like to thank you for your evaluation of our excellent staff.

This concludes my greetings.