Meeting of representatives
Secretariat Report

December 08, 2022

EBC Medical Euipment and IVD Committee
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UnrestrictedToday's agenda

15 : 00 - 15 : 15 (15 minutes )1.Confirmation of meeting completion
2.Appointment of meeting chairman
3.Opening remark - Chairman(R) Summary of Activities in 2022
(D) 2023 Activity Policy
4. Report of the Secretariat(D) monthly meeting Schedule(R) Financial Report 2022
(D) The 2023 Budget

15 : 15-15 : 30 (15 minutes)
5. Digital Health Task Force- 2022 Activity Report- 2023 Activity Policy
15 : 30-16 : 10 (40 minutes)
6. MD / Medical Fee Subcommittee- 2022 Activity Report- 2023 Activity Policy

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16:10-16:20
Break16 : 20-16 : 40 (20 minutes)
7. MD / Pharmaceutical Affairs
Subcommittee- 2022 Activity Report- 2023 Activity Policy
16 : 40-17 : 20 (30 minutes)
8. IVD Subcommittee- 2022 Activity Report- 2023 Activity Policy
17 : 20-17 : 9. Closing remark _ First
Vice Chairman
30 (10 minutes)

Confirmation of meeting completion

As of December 2022, 31 member companies were registered⚫Representatives 7 companies
31 companies⚫ Submissions of power attorney 24 companies- Chairperson : 17 companies- Substitute attendees : 7 companies⚫No response

0 companies

Constitution
Admission⚫ Corcym Japan Ltd. 2022 Feb.
⚫ ZAP Surgical Japan GK 2022 Nov
Withdrawal◆ Medtronic Japan Co., Ltd. 2022 Jan.

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Election of Meeting Chairperson :Appointed by the Chairperson
Teisoku (Article 17) : Attendance of amajority of members
Voting (Article 18) : Majority ofmembers presentChairman’s Opening remark◆Executive Summary of Activities in 2022
◆Activity Policy for 2023

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(R) Summary of Activities in 2022
◼ Strengthening policy advocacy activities✓ All completed without delay at the UDI in the final December of the third year of implementation of the Pharmaceutical andMedical Devices Law✓ Expansion of the scope of application for challenge (reevaluation based on the results of use after new listing)✓ Full-scale implementation of MDSAP (Medical Device Single Audit Program) in Japan✓ Clarification of appropriateness and evaluation of programmed medical devices, and reinforcement of review system (PMDA,MHLW consultation desk)➢ Recommendations on cybersecurity and data protection➢ Utilize to the application for RWD and secondary use of medical data including AI➢ Discussion on promotion of MDSRP (Medical Device Single Review Program)➢ Description of the English brand name of the importer in the marketing approval / certificate➢ Measures to Enhance Stable Supply➢ Application of implantable medical device information to medical data
➢ Opinions on revision of infectious disease law and infectious disease-related tests➢ Review of the review classification of pathogen gene products (to review them as approval standard products)➢ Revision of the definition of in-vitro diagnostics➢ Revision of qualification requirements for MAH-general of in-vitro diagnostics◼ Deregulation in Japan and Europe➢ Mutual acceptance of GCP compliance review results based on multinational clinical trials, etc.
➢ Webinar on the German Program Medical Device Insurance Scheme DiGA
➢ Introduction to European Digital Strategy◼ Strengthening relations with related organizations➢ Meeting with the new Counselor of the MHLW
➢ Exchange of opinions with the Pharmaceutical Industry Promotion and Medical Information Planning Division, Health Policy
Bureau, MHLW
➢ Exchange of opinions with the Medical and welfare tool Industry Office, Healthcare Industry Division, Commerce and ServiceGroup, METI
➢ Cooperation with the Delegation of the European Union to Japan➢ Opinion on Stable Supply with AMDD, MTJAPAN➢ EBC White Paper◼ Proposal for Medical Fee Revision➢ Proposal for an insured provisional approval system for programmed medical devices
Page5 ➢ Promotion of preventive medicine - Introduction of low-dose lung cancer computed tomography to Lung Cancer Examination

(D) 2023 Activity Guidelines◼ Strengthening policy advocacy activities

Continue :➢ Recommendations on cybersecurity and data protection➢ Utilize to the application for RWD and secondary use of medical device including AI➢ Discussion on promotion of MDSRP (Medical Device Single Review Program)➢ Description of the English brand name of the importer in the marketing approval / certificate➢ Measures to Enhance Stable Supply➢ Application of implantable medical device information to medical data
➢ Opinions on revision of infectious disease law and infectious disease-related tests➢ Review of the review classification of pathogen gene products (to review them as approval standard products)➢ Revision of the definition of in-vitro diagnostics➢ Revision of qualification requirements for MAH-general of in-vitro diagnostics◼ Deregulation in Japan and Europe➢ Mutual acceptance of GCP compliance review results based on multinational clinical trials, etc.
➢ Opinions on revision of infectious disease law and infectious disease-related tests➢ Review of the review classification of pathogen gene products (to review them as approval standard products)➢ Revision of the definition of in-vitro diagnostics➢ Revision of qualification requirements for production and marketing of in-vitro diagnostics◼ Deregulation in Japan and Europe➢ Mutual acceptance of GCP compliance review results based on multinational clinical trials, etc.
➢ Follow-up on the German Programmed Medical Device Insurance Scheme DiGA
➢ Study : MDR/IVDR, insurance systems in major European countries, RWD utilization◼ Strengthening relations with related organizations➢ Exchange of opinions with the Pharmaceutical Industry Promotion and Medical Information Planning Division, Health Policy
Bureau, MHLW, and the Medical Devices Evaluation and Licensing Division, Pharmaceutical and Human Health Bureau➢ Exchange of opinions with the Medical and welfare tool Industry Office, Healthcare Industry Division, Commerce and ServiceGroup, METI
➢ Cooperation with the Delegation of the European Union to Japan◼ Proposal for Medical Fee Revision➢ C2 Applicability of New Technology and Predictability of Insurance➢ Evaluation Process for Medical Devices Related to Medical Technology Evaluation Proposal➢ Proposal for an insured provisional approval system for programmed medical devices
Page6➢ Innovation Evaluation System for Clinical Testing of In-vitro Diagnostics

Basic Recognition for the Next Revision (146th Social Security Council, InsuranceCommittee, October 22, 2021
Key Issues :◆ Medical Care System for Novel Coronavirus Infections• Appropriate Role-Sharing in Regional Medicine : Differentiation, Strengthening, andCooperation• Evaluation and functional differentiation of Hospital Treatment and outpatienttreatment• High-quality home care
◆ Promotion of work style reform for doctors, etc.
• 2024 Limitation on overtime work for doctors• Promoting Task Sharing, Task Shifting and Team Medicine• Securing emergency medical care systems• Promotion of ICT utilization that contributes to operational efficiency◆ Other
Online medical care, fertility treatment and high-quality cancer care
Appropriate evaluation of medical technology, etc. based on evidence and relative clinicalusefulness

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Secretariat Report

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Summary of Activities in 2022
Major annual events 2022
January : Practitioners’ Meeting (MD/IVD) for Collaborative Planning to Speed Up Medical Device Examination
March : Survey on purchase price and distribution cost
May : Submission of requirements for stable supply to Minister of MHLW and Minister of METI
June : Steering Meeting and Prior Meeting for Practitioners’ Meeting on Collaborative Planning to Speed Up Medical Device Examination
Revision of the Infectious Diseases Law Industry opinion meeting
Consultations on stable supply : MHLW Economic Affairs Division and METI Medical & Welfare Office
July : Practitioners’ Meeting (MD/IVD) for Collaborative Planning to Speed Up Medical Device Examination
Interview with the Director of Medical Device Policy Office, Economic Affairs Division Health Policy Bureau
August : Exchange of opinions of the Pharmaceutical Industry Promotion and Medical Information Planning Division, Health Policy Bureau
Interview with Counselor Health Policy Bureau, MHLW
Medical DX Lecture + Information Exchange Meeting
September : Periodic Opinion Exchange Meeting (MHLW / PMDA : Review / Regulatory related )November : German DiGA Webinar

Cost-effectivenessevaluation
System Subcommittee
Activities
Activities of various
committees of theFederation of Medical andCreation of Innovative Pharmaceuticals, Medical Devices and Regenerative Medicine Products Public-Private Dialogue
EBC White Paper
Month 2023,1 : Regular Meeting (Medical Fee Related), Practitioners’ Meeting (MD/IVD)

Monthly meeting

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(D) Plan to hold the 2023 monthly meetingand Representatives Meeting
Time : 2 : 30 to 5 : 00 p.m.
Place : Siemens Healthcare, 5th floor conference
room / WEB

Dates :
Thursday, January 26
Friday, February 24
Thursday, March 23Thursday, April 20
Thursday, May 25
Thursday, June 22
Thursday, July 20
August 24th (Thu) + information exchange meeting
Thursday, September 21
Thursday, October 19
Thursday, November 16
December 07 (Thu) Representatives meeting + informationexchange meeting

Page10(R) Financial Report 2022
March 2023 forecast
2022年予算

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前年度繰越金Carry-over from previous year

会費

Membership fee

情報交換会参加費

Participation fee for information exchange
meeting

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

収入合計

Total Revenue

事務局運営費（人件費）

Operating expenses (personnel expenses)

代表者会議＋情報交換会

2022年11月実績

2023年3月までに発生する予定費用

vs. 予算¥12,353,273

2023年3月末FC

FC vs. 予算¥12,353,273¥5,800,000¥6,200,000

106.9%¥0¥6,200,000

106.9%¥300,000¥93,000

31.0%¥120,000¥213,000

71.0%

¥56
¥6,100,000¥6,293,056¥18,453,273#DIV/0!
103.2%¥120,000

0.0%¥6,413,056

105.1%¥18,766,329

101.7%¥3,400,000¥1,518,195

44.7%¥1,084,425¥2,602,620

76.5%

Representative Meeting + Information
Exchange Meeting¥800,000¥1,221,000

152.6%¥390,000¥1,611,000

201.4%

医機連会費

JFMDA membership¥600,000¥600,000

100.0%¥0¥600,000

100.0%

調査・翻訳費Research and translation costs¥600,000¥00.0%¥350,000¥350,00058.3%

事務局活動費Secretariat activity expenses¥80,000¥43,67454.6%¥31,196¥74,870

93.6%

部会・TF活動費

Expenses for subcommittee and TF
activities¥400,000¥200,000

50.0%¥150,000¥350,000

87.5%

HPメンテ費Hpmaintenance cost

¥30,000¥00.0%¥0¥00.0%

その他（雑費）

Other (miscellaneous expenses)¥20,000¥3,74018.7%¥5,000¥8,740

43.7%

支出合計

Total Expenses¥5,930,000¥3,586,609

60.5%¥2,010,621¥5,597,230

94.4%

本年度収支決算（損益分）

Settlement of accounts for this fisical year
(profit and loss)¥170,000¥2,706,447¥815,826

479.9%

本年度繰越金Current year carry-over)¥13,169,099

105.2%¥12,523,273

(D) 2023 Budget (draft)

2022年予算

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2023年3月FCvs. 予算2023年予算案

予算 vs. 2023年3月FC

Note¥12,353,273¥12,353,273¥5,800,000¥6,200,000

106.9%¥6,200,000

100.0%¥300,000¥213,000

71.0%¥300,000

140.8%¥0¥0¥6,100,000¥6,413,056

105.1%¥6,500,000

101.4%¥18,453,273¥18,766,329

101.7%¥19,669,099

104.8%¥3,400,000¥2,602,620

76.5%¥3,400,000

130.6%

Representative Meeting + Information
Exchange Meeting¥800,000¥1,611,000

201.4%¥1,800,000

111.7% ﾖｰﾛｯﾊﾟﾊｳｽ情報交換会

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¥350,000

58.3%¥600,000

171.4%

事務局活動費Secretariat activity expenses¥80,000¥74,87093.6%¥200,000

267.1% 大使館・商工会議所等

部会・TF活動費

Expenses for subcommittee and TF
activities¥400,000¥350,000

87.5%¥3,000,000

HPメンテ費Hpmaintenance cost

¥30,000¥00.0%¥30,000

その他（雑費）

Other (miscellaneous expenses)¥20,000¥8,74043.7%¥20,000

228.8%

支出合計

Total Expenses¥5,930,000¥5,597,230

94.4%¥9,650,000

172.4%

本年度収支決算（損益分）

Settlement of accounts for this fisicalyear (profit and loss)¥170,000¥815,826¥-3,150,000

本年度繰越金Current year carry-over)¥12,523,273¥13,169,099¥10,019,099

前年度繰越金Carry-over from previous year

会費

Membership fee

情報交換会参加費

Participation fee for informationexchange meeting

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

収入合計

Total Revenue

事務局運営費（人件費）

Operating expenses (personnelexpenses)

代表者会議＋情報交換会¥13,169,099¥0#DIV/0!

857.1% MDR/IVDRｾﾐﾅｰ､DiGA update#DIV/0!

80.0%

Thank you for listening.
We look forward to your continued understanding and cooperation inour activities.

Thank you for your attention
We ask for your continued understanding and cooperation in theactivities of the committee members.

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