Meeting of representatives
Secretariat Report

December 07, 2023

EBC Equipment and IVD Committee
Page 1
UnrestrictedConfirmation of the meeting completion

As of December 2023, 34 member companies were registered⚫Representatives 1033

⚫Submissions of power attorney－Delegation ： 14－Substitute ：9⚫Not answred
123

Admission
⚫
⚫
⚫
⚫
⚫
⚫

TR3 LLC 2023Mar.
AI Medical Service Co., Ltd. 2023Mar.
Jin Healthcare Consulting 2023May
CathWorks Japan LLC 2023Jun.
Beckman Coulter, Inc. 2023 Nov.
(PARI Japan LLC 2024Jan.)
Withdrawal◆ ZAP Surgical Japan LLC 2023 Mar.

Page 22023年

会員企業一覧（法人別）
As of 2023 Dec. 01

Page 3

1Philips Japan, Ltd.

21

Japan MDC LLC

2TR3 LLC

22

Roche Diagnostics K.K.

3

Jin Healthcare Consulting

23

Maruho Co., Ltd.

4

RADIOMETER K.K.

24

LivaNova Japan K.K.

5

Beckman Coulter, Inc.

25

Coloplast K.K.

6

BioMérieux Japan Ltd.

26

Draeger Japan K.K.

7

Guerbet Japan KK

27

Japan Lifeline Co., Ltd.

8

Integral Co.,Ltd.

28

Corcym Japan K.K.

9

QIAGEN K.K. -Japan

29

Telix Pharmaceuticals Japan K.K.

10

Nippon BXI Inc.

30

Novocure K.K.

11

Mölnlycke Health Care AB.

31AI Medical Service Co., Ltd.

12

Medis Medical Imaging Systems B.V.

32

CathWorks Japan LLC

13GUNZE MEDICAL Ltd.

33

EDAP Technomed Inc.

14

BIOTRONIK Japan Inc.

34

Japan Medical Next K.K.

15

B.BRAUN AESCLAP JAPAN CO., LTD.

35

K.K. TKB

16

Thermo Fisher Diagnostics K.K.

36

Dornier MedTech Japan K.K.

17

Life Technologies Japan Ltd.

37

PARI Japan LLC

18

Varian Medical Systems, Inc.

38

19

Siemens Healthcare K.K.

39

20

Siemens Healthcare Diagnostics K.K.

40

Today’s agenda

Page 4

Chairman’s Opening remark◆Executive Summary of Activities in 2023
◆Activity Policy for 2024

Page 5

Summary of activities in 2023
◼ Strengthening policy advocacy activities➢ Expanding the scope of challenge applications (securing a period in which trial plans can be drawn up, responding to new efficacy afterputting market on) and qualification➢ Qualification and Clarification of the evaluation of program medical devices and strengthening of examination system (PMDA/MHLW
Consultation Desk)➢ Recommendations regarding cyber security➢ Regarding the use of RWD for applications and secondary use of medical data including AI➢ Discussion on promoting MDSRP (Medical Device Single Review Program) ⇒ Regular opinion exchange meeting➢ Regarding the description of the importer's English brand name on the manufacturing and sales approval/certificate➢ Communicate abroad about Japanese regulations ⇒ Collaborative plan/English translation➢ Regarding measures to strengthen stable supply ⇒Public-private dialogue/Regular meetings➢ Development of implanted medical device information into medical data ⇒Regular opinion exchange meeting➢ Submission of opinions regarding the revision of the Infectious Diseases Act and the state of infectious disease-related testing➢ Review of the definition of in vitro diagnostic drugs ⇒Public-private dialogue and regular opinion exchange meetings➢ Review of qualification requirements for MAH General of in vitro diagnostic drugs➢ Review of review categories for pathogen gene items (toward review as approval standard items)◼ Deregulation in Japan and Europe➢ Collaborative plan for optimizing medical device regulation and review (5 years)⇒ Active participation in the final year
➢ Mutual acceptance of GCP compliance survey results based on international joint clinical trials, etc. (regular opinion exchange meetings)➢ Webinar held on German medical insurance and reimbursement system (including DiGA)➢ Introducing the European Digital Strategy◼ Strengthening relationships with related organizations➢ Cooperation with the Delegation of the European Union to Japan➢ EBC White Paper➢ Liberal Democratic Party Health, Labor and Welfare Committee ⇒ Lecture: Chairman Tabata “Trends in Digital Health”◼ Proposals for reforming medical fees

➢ The state of insurance in the two-stage approval system for programmed medical devices (proposal for combination therapy not coveredby insurance)➢ Promotion of preventive medicine - Introduction of low-dose lung cancer CT for lung cancer screening (reducing medical costs)➢ Issues with stable supply (unprofitable products, foreign price adjustments, etc.)

Page 6

2024 activity policy◼ Strengthening policy advocacy activities-Continuation :➢➢➢➢Discussion on promoting MDSRP (Medical Device Single Review Program)
Regarding the description of the importer's English brand name on the manufacturing and sales approval/certificate
Regarding measures to strengthen stable supply ⇒Public-private dialogue/Regular meetings
Submission of opinions regarding the revision of the Infectious Diseases Act and the state of infectious disease-related testing✓ Expanding the scope of challenge applications (securing a period in which trial plans can be drawn up, responding tonew efficacy after putting market on) and qualification✓ Recommendations regarding cyber security✓ Regarding the use of RWD for applications and secondary use of medical data including AI✓ Review of the definition of in vitro diagnostic drugs (independence from the “drug” classification under thePharmaceutical and Medical Devices Act)
➢ Review of qualification requirements for MAH General of in vitro diagnostic drugs➢ Review of review categories for pathogen gene items (toward review as approval standard items)◼ Deregulation in Japan and Europe✓ Collaborative plan for optimizing medical device regulations and reviews (5 years)
fiscal year

⇒ Active participation in the new➢ Mutual acceptance of GCP compliance survey results based on international joint clinical trials, etc.
➢ Introduction to the European Digital Strategy (RWD/RWE, Data Space, requirements for data used in reviews, related laws and regulations, etc.)◼ Strengthening relationships with related organizations➢ Strengthening relationships with the trade departments of each country's embassies◼ Proposals for reforming medical fees
✓ The state of insurance in the two-stage approval system for programmed medical devices (proposal for combination
therapy not covered by insurance)✓ Promotion of preventive medicine - Introduction of low-dose lung cancer CT for lung cancer screening (reducingmedical costs)✓ Issues with stable supply (unprofitable products, foreign price adjustments, etc.)

Page 7

Secretariat

Page 8

Summary of activities for 2023
Major annual events 2023
Jan：Regular meeting (FY2022)
Jun：Japan Small and Medium Enterprise Agency 8Business matching measures between overseaand Japanese companies) briefing session
MDR/IVDR study session (MHLW, PMDA etc.)
Jul：Regular meeting (FY2023)
Aug：Medical DX lecture/ German insurance system lecture sessions⚫ Overview of the German insurance system andinsurance reimbursement system –Ms. Keiko Yoshida⚫ Looking ahead to the 2024 medical fee revision:Trends in digital health – Mr. Hiroaki Tabata

Sep：Regular opinion exchange meeting regarding approval reviews andsafety measures for medical devices and in vitro diagnostic reagents
Nov：Public-private dialogue to create innovative medicines, medical devices, regenerative medicine
products, etc.
Dec： EBC White paper

Chuikyo Industry Opinion Statement
Medical Association various committee activities
Collaborative plan for expediting medical device reviews
Conference on improving the distribution of medical devices
Study group on ensuring stable supply of medical equipment
monthly meeting

Page 9(D) 2024 monthly meeting, representative
meeting holding plan
Time: 2:30pm to 5:00pm
Location: Siemens Healthcare, 5th floor conference room/WEB
schedule:••••••••••••

Page 10Thursday, January 25thTuesday, February 20thThursday, March 21stThursday, April 18thThursday, May 23rdThursday, June 20thThursday, July 18th
August 22nd (Thursday) + Information exchange meeting
Thursday, September 19th
Thursday, October 17th
Thursday, November 14th
December 12th (Thursday) Representative meeting + Information exchangemeeting

(R) 2023 Financial Report
Forecast for March 2024
決算予想報告2023 BD

2023Nov. Actual

2023年予算

Expected costs to be
2024Mar. FC
incurred by March 2024

vs. BD2023年11月実績

2024年3月までに発生する予定費用vs. 予算

FC vs. BD

2024年3月末FC

FC vs. 予算

前年度繰越金Carry-over from previous year

¥13,512,275

会費

Membership fee¥6,200,000¥6,300,000

101.6%¥0¥6,300,000

101.6%

情報交換会参加費

Participation fee for informationexchange meeting¥300,000¥96,000

32.0%¥180,000¥276,000

92.0%

その他（利子等雑収入）

Other (miscellaneous income such asinterest)

今年度収入合計Total revenue for this fiscal year

¥6,500,000

収入合計

Total Revenue¥20,012,275

事務局運営費（人件費）

Operating expenses (personnelexpenses)¥3,400,000¥1,741,605

51.2%

代表者会議＋情報交換会（夏・冬）

Representative Meeting +Information Exchange Meeting¥1,800,000¥1,112,100

61.8%

医機連会費

JFMDA membership¥600,000¥600,000

調査・翻訳費Research and translation costs¥600,000¥631,400

事務局活動費Secretariat activity expenses¥200,000

部会・TF活動費

Expenses for subcommittee and TF
activities

HPメンテ費Hpmaintenance cost

その他（雑費）

Other (miscellaneous expenses)

支出合計

Total Expenses

本年度収支決算（損益分）

Settlement of accounts for this fisicalyear (profit and loss)¥-3,150,000¥17,489

本年度繰越金Current year carry-over)¥10,362,275¥13,529,764

Page 11¥13,512,275¥20,061¥6,416,061#DIV/0!

98.7%¥180,000¥6,596,061

101.5%¥20,108,336

100.5%¥1,244,004¥2,985,609

87.8%¥600,000¥1,712,10095.1%

100.0%¥0¥600,000

100.0%

105.2%¥200,000¥831,400

138.6%¥48,44424.2%¥40,000¥88,44444.2%¥3,000,000¥175,000

5.8%¥150,000¥325,000

10.8%¥30,000¥24,19580.7%¥0¥24,195

80.7%¥20,000¥6,82434.1%¥5,000¥11,82459.1%¥9,650,000¥4,339,568

45.0%¥2,239,004¥6,578,572

68.2%

0.0%

130.6%

(D) 2024 Budget (draft)
予算案 BD (draft)

2023 BD2024Mar. FC

2023年予算

2024年3月FC

2024Mar.FC vs.

2024 BD draftvs. 予算2023Mar. FC

2024年予算案

予算 vs. 2024年3月FC

前年度繰越金Carry-over from previous year

¥13,512,275

会費

Membership fee¥6,200,000¥6,300,000

101.6%¥6,700,000

106.3%¥300,000¥276,000

92.0%¥300,000

108.7%¥0¥0

情報交換会参加費

その他（利子等雑収入）

Participation fee for informationexchange meeting
Other (miscellaneous income suchas interest)¥13,529,764¥0#DIV/0!

今年度収入合計Total revenue for this fiscal year

¥6,500,000¥6,596,061

101.5%¥7,000,000

106.1%

収入合計

Total Revenue¥20,012,275¥20,108,336

100.5%¥20,529,764

102.1%¥3,400,000¥2,985,609

87.8%¥3,400,000

113.9%¥1,800,000¥1,712,100

95.1%¥1,800,000

105.1%

事務局運営費（人件費）

代表者会議＋情報交換会

Operating expenses (personnelexpenses)
Representative Meeting +Information Exchange Meeting

医機連会費

JFMDA membership¥600,000¥600,000

100.0%¥600,000

100.0%

調査・翻訳費Research and translation costs¥600,000¥831,400

138.6%¥1,000,000

120.3%

事務局活動費Secretariat activity expenses¥200,000¥88,44444.2%¥150,000

169.6%¥3,000,000¥325,000

10.8%¥2,000,000

615.4%

部会・TF活動費

Expenses for subcommittee and TF
activities

HPメンテ費Hpmaintenance cost

¥30,000¥24,19580.7%¥30,000

124.0%

その他（雑費）

Other (miscellaneous expenses)¥20,000¥11,82459.1%¥20,000

169.1%

支出合計

Total Expenses¥9,650,000¥6,578,572

68.2%¥9,000,000

136.8%¥-3,150,000¥17,489¥-2,000,000¥10,362,275¥13,529,764¥11,529,764

本年度収支決算（損益分）

本年度繰越金Page 12vs. BD

Settlement of accounts for thisfisical year (profit and loss)
Current year carry-over)

111.3%

ご清聴ありがとうございます
今後とも委員活動へのご理解ご協力を賜りますようお願いいたしますThank you for your attention
We ask for your continued understanding and cooperation in theactivities of the committee members.

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