2 022 EBC Remarks by the Chairman of the Board of Representatives

This is Mr. Mori, the chairperson. Thank you very much for taking the time out ofyour busy schedule to attend the meeting of representatives of the MedicalDevices IVD Committee.
Over the past year, in addition to the coronavirus crisis, various problems havecome to Japan, including the issues of Russia and Ukraine, natural disasters suchas earthquakes and heavy rain, and missile launches from North Korea. Costs
have risen in various ways due to a shortage of semiconductors, a shortage of rawmaterials and usual materials, a shortage of human resources, and the impact ofthe depreciation of the yen. Even though we in the medical device industry havenot been able to pass on costs to customers, we have made efforts to contributeto system reform through stable supply, provision of medical care in times ofdisaster, and medical care DX.
In addition, amidst similar turmoil around the world, Japan has made various
efforts to bring as much as possible necessary items, such as coronavirus antigen
test kits, to Japan.

Under such circumstances, through the activities of the Committee, we have beenable to continue to make policy proposals, to promote deregulation, to makeproposals on medical treatment fees, and to strengthen relations with relatedorganizations as you have seen. This is due to the understanding of you and theefforts of the member companies who have actually made such efforts. Thank youagain.
2022 is the third year of the revision of the Pharmaceutical and Medical Devices
Law in 2020 and also the year of completion. This month's UDI, "Obligation toDisplay Barcodes on Packages, etc.", has implemented all of these regulations. Inaddition, the Challenge Application became available in an expanded manner, andit was also the year when the full-scale implementation of MDSAP started.
Further studies on programmed medical devices are ongoing and discussions arebeing held regarding their applicability and evaluation methods. Various proposals
have also been made on how to ensure the predictability of insurance.
This summer, we invited all of you for the first time in three years, invited Ministerof Health, Labour and Welfare Katoh and Professor Mano to the venue of theEuropa House of the European Union to Japan, and gave a lecture on medical

DXs. I was also pleased to have a lively information exchange meeting with you
on F2F for the first time in a long time.
There are still many issues to be addressed, but I think it was a fruitful year.
Now 2023 As you can see, we must continue to work on many of the issues that
we should work on during the fiscal year.
Among them, cyber security for medical institutions that has been in the news
recently, revision of the Infectious Diseases Law, provisional approval system forprogrammed medical devices with insurance, C2 challenge, and even bigger, who
are in-vitro diagnostics? We must establish the basic standing position of IVD andcreate a foundation that can solve the unclear problems so far.
Also, since we are a European company, it is a very important activity to increase
our presence to send various European information including DiGA to Japan.
Following on from last year, DiGA webinars have generated a great response thisyear. Thank you very much.
In addition, 2023 year is Reiwa 6 year ( 2024 year) is the year of preparation forthe medical fee revision, and it is expected that our corporate activities in thefuture will produce very significant results. I believe that there will be more andmore expectations for the activities of this Committee in the future, but I would

like to ask the members to continue to be active, and more importantly, I would
like to ask for the understanding of the company representatives and their highevaluation.
In that case, I would like to wish each of you all good luck and report to you.
Thank you very much for today. We also ask you to attend the Information
Exchanging after the meeting.
Above