Greeting from the chairman
While COVID-19 has subsided a little, it is still difficult to concentrate on normal work
because of new viruses, so I would like to thank the representatives for gathering, even though
it is online. We would like to express our sincere gratitude for your continued support for theactivities of the committee.
We have worked on workplace vaccination of COVID-19 vaccines as EBC this year. And thankyou for your cooperation regarding vaccination in areas other than Tokyo.
Thanks to you, we would like to extend our sincere gratitude to all of you for continuingbusiness without any problems, and without any clusters occurring within the committeecompanies.
Today, I would like to report on the activities of the committee in 2021 and the 2022 activitypolicy.

Major annual events in 2021

Feb. Reiwa 2 fiscal year regular meeting (medical fees related)
Mar. Submission of medical fee revision request
Apr. IDATEN, PHOENIX, APAC Med study session
Apr.-Jun.

Discussions with the Data Health Promotion Special Committee (LiberalDemocratic Party)
Jul.

PMDA : Meeting for MDSAP April 2022 Full-scale introductionReiwa 3 fiscal year regular meeting (medical fee related)
Established Digital Health Task Force

Aug. Regular discussion meeting (related to the PMD act)
Irish Government Commerce Agency Office in Japan"Information on the Irish Medical Device Industry"
Sep.

DiGA (German program medical device insurance listing program) Webinar held
(Ministry of Health, Labor and Welfare, PMDA, industry)

Oct.

Exchange of opinions with the Economic Affairs Division (Chief Ando, Chief ofPolicy Office Horioka)
Foreign price survey
Nov.

Statement of industry opinion at the Central Social Insurance Medical CouncilJan. Reiwa 4

Collaborative plan working-level meeting (planned)◆2021 Activity Report

2021 is the second year since the revision of the PMD act was enacted. The committee has
been working to realize the revised act without delay, including making it a principle toprovide attached documents (tempu-bunsho) electronically, establishing a legal compliancesystem for MAHs and distributors and introducing a surcharge system due to falsification orhype on the sale of medical devices. 2022 will be the third year, and we will carefully proceed
toward mandating the display of barcodes on packaging.
Furthermore, for system reform, we will work throughout the year on a collaborative planwith the government, and in January of the next year, we plan to hold a working-levelmeeting for both medical devices and IVD to discuss past efforts and new systems.
At this meeting last year, I mentioned that there was something good about the COVID-19
pandemic. That is the digital transformation of PMDA and the abolishment of the stamp(Hanko) as a COVID-19 infection prevention measure. From this summer, online
applications related to notifications has been available. I also heard that it will be possible toapply for approval next year. The change to paperless for documents to be submitted toPMDA may be an interesting change that will lead to cost reduction for representatives,
such as printing costs for pharmaceutical and medical devices affairs and cabinet space.
Regarding eHealth, this year we launched the Digital Health Task Force within thecommittee, which allows us to work across each subcommittee. A webinar was held byinviting the person in charge of studying the APAC MedTech activities.
Also, we invited the person in charge of formulating the insurance listing application
program for program medical devices (SaMD: software as medical device) in Germany andheld a webinar with the Economics Division of MHLW, Medical Device Review andManagement Division of MHLW, PMDA and related organizations.
We were able to learn about differences and findings in the value and evaluation of program
medical devices as reimbursement.
Regarding medical fees, we have continued to promote the evaluation of innovation. We
have continued to disseminate our opinions as EBC regarding the handling of program
medical devices by the reimbursement system and C2 challenges at regular meetings,
through industry opinion statements and towards the revision of medical fees next year.
Various devices, including AI, will be on the market in the future. We will continue to work
toward a system that can respond to these issues and allow companies to develop as abusiness.

Regarding in-vitro diagnostic drugs, we will continue to apply for challenges, and we are
currently in discussions with the government regarding repurposing of companion
diagnostic drugs.

◆2021 Activity Policy

Regarding utilization of real-world data, which is of great interest to everyone, in approval
reviews, we will identify issues in utilization and proceed with discussions with thegovernment to realize its utilization. The revised Personal Information Protection Law isscheduled to come into effect in Japan next year, and the committee must endeavor tocollect and disseminate information regarding the utilization and protection of overseas
data. In addition, we will hold discussions with the government at the working- levelmeeting regarding issues related to program medical devices.
The reimbursement subcommittee will work on issues of special materials related to foreign
prices, functional categories, and unprofitable departments. In addition, we will expand
appropriate evaluation of innovations so far, including in the fields of radiotherapy andnuclear medicine diagnostic treatment for new companies participating in diagnostic
treatment equipment, and we will continue to develop activities for the next medical feesrevision. We will also concentrate on the final push toward the implementation of C2
challenges, which is related to the insurance listing of program medical devices.
The IVD subcommittee will further promote initiatives centered on collaborative plans,
while identifying issues and conducting activities in anticipation of the next revision of thePMD act. In addition, we will start activities for the medical fees revision in Reiwa 6 (2024).
Thank you again for participating. We ask for your understanding and support for theactivities of this committee, and wish you success in your business.
Yours sincerely