EBC Medical Equipment and Diagnostics Committee
Secretariat Report

2021.12.09

欧州ビジネス協会（EBC）医療機器・ＩＶＤ委員会
Page 1
Unrestricted本日の議事次第
15:00 – 15:10 (15 min.）1. Confirmation of meeting
establishment
2. Appointment of chair
3. Greeting from the chairman(R) 2020 activity summary(D) 2021 activity policy
4. Secretariat report（Ｄ）Schedule of monthly
meeting(R) 2021 accounting report(D) 2022 budget
15:15 – 15:20 (5 min.)5. Mirai project
15:20-15:30 (10 min.)
6. Digital health task force

Page 2

15:30 – 16:00 (30 min.）
7. MD/medical fee subcommittee- 2021 Activity summary- 2022 Activity policy
16:00 – 16:20 (20 min.）
8. MD/yakuji subcommittee- 2021 activity summary- 2022 activity policy
16:20 – 16:50 (30 min.）9. IVD subcommittee- 2021 activity summary- 2022 activity policy
16:50 – 16:55 (5 min.）10. Closing remarks first vice-chairman

Confirmation of meeting establishment

Number of registered member companies: 30 as of Dec. 2021
⚫Representative attendance

628⚫Submission of power of attorney

22－Delegation to the chairman－Attendance of agent⚫Unanswered2：：148Constitution
Election of chair: Appointed by chairman
Quorum (Article 17): Attendance of amajority of members
Decision (Article 18): Majority of attendingmembers

Page 3Greeting from the Chairman◆2021 activity summary◆2022 activity policy

Page 4

(R) 2021 activity summary◼ Strengthening of policy advocacy activities• Request continuous improvement to the Pharmaceuticals and MedicalDevices Act (PMD act)
• Actively participate in collaborative plans for medical device regulation andexpedited review• Work on implementation of the revision of the PMD act (governance, UDI,MDSAP, IDATEN, PHOENIX, etc.)◼ Deregulation in Japan and Europe• Promote mutual certification based on European regulatory revisions• International alignment activities◼ Strengthening of relationships with related organizations• Strengthen relationships with the Ministry of Health, Labor and Welfare,
PMDA, Ministry of Economy Trade and Industry, Ministry of Internal Affairs
and Communications, etc.
◼ Activities for the 2022 revision of medical fees
• Create a new medical fee system - Towards 2022
• Develop market for preventive medicine and preemptive medicinePage 5eHealth
Collab. plans / working-levelmeetings
IDATEN + AI, PHOENIXeIFU, UDI, MDSAP,MDSRP(GRRP)
Regular discussion meeting
Dissemination of MDR/IVDR info.
ISO14971,IEC62366-1
DiGA Webinar/APAC
Medical Policy Bureau- eHealth data utilization- Exchange of opinions with theEconomic Affairs Division
Pharmaceutical, Living andHygiene Bureau- MDR/IVDR study session
DX – review processes]
Health dataAIC2 challenge
Telemedicine / robot
Regular meeting

(D) 2022年活動指針◼ Strengthening of policy advocacy activities• Request continuous improvement to the Pharmaceuticals and Medical
Devices Act (PMD act)
• Actively participate in collaborative plans for medical device regulation andexpedited review• Work on implementation of the revision of the PMD act (bar code displayon packing, etc.)◼ Deregulation in Japan and Europe• Promote mutual certification based on European regulatory revisions• International alignment activities◼ Strengthening of relationships with related organizations• Strengthen relationships with the Ministry of Health, Labor and Welfare,
PMDA, Ministry of Economy Trade and Industry, Ministry of Internal Affairs
and Communications, etc.
◼ Activities for the 2023 revision of medical fees
• Create a new medical fee system - Towards 2023
• Develop market for preventive medicine and preemptive medicine

Page 6eHealthCollab. plans / working-levelmeetings
MDSAP follow-up
MDSRP(GRRP) trends
Regular discussion meeting

Dissemination of MDR/IVDR info.
- EU Data Policy- DiGA follow-up
Medical Policy Bureau- eHealth data utilization
Pharmaceutical, Living andHygiene Bureau- MDR/IVDR study session- DX – review processes]
Special materials:
Foreign price / functionalclassification / innovation ofdiagnostic treatment equipment
Program medical device + AI
C2 challenge
Telemedicine / robot
IVD R6 medical fee revision
supportRegular meetingReport from Secretariat

Page 72021 activity summary
Major annual events in 2021

Feb. Reiwa 2 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 (Liberal Democratic Party)
Jul. PMDA : Meeting for MDSAP April 2022 full-scale introduction
Reiwa 3 regular meeting (medical fees related)
Established Digital Health Task ForceAug. Regular discussion meeting (related to the PMD act)

• Cost-effectivenessevaluation• Institutional
subcommittee activities• JFMDA various
committee activities

Irish Government Commerce Agency Office in Japan"Information on the Irish Medical Device Industry"
Sep.

• Monthly meeting

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 of Policy Office Horioka)
Foreign price survey

Nov.

Statement of industry opinion at the Central Social Insurance Medical Council

Jan. R4 Collaboration plan working-level meeting (planned)
Page 8

(D) 2022 monthly meeting, representative meetingholding plan
Time: From 2:30 pm to 5:00 pm
Location: Siemens Healthineers 5th floor meeting room (in principle)
Schedule:
January 20th (Thu)
February 24th (Thu)March 24th （Thu)
April 21st (Thu)
May 26th (Thu)
June 23rd (Thu)
July 21st (Thu)August 25th (Thu) + information exchange meeting
September 15th (Thu)
October 20th (Thu)November 17th (Thu)
December 08th (Thu) representative meeting + information exchange meeting

Page 9(R) 2021 accounting report
2022 March forecast
2021 budget

2021 Nov. result

Expected costs
incurred by 2022 Mar.

vs. budget

2022 Mar. FC

FC vs. budget

Previous year carryforward¥10,155,586

Membership fee¥5,600,000¥6,000,000

107.1%¥0¥6,000,000

107.1%¥300,000¥00.0%¥0¥00.0%

¥0

¥45

¥0

¥45

Total income this year 2021

¥5,900,000¥6,000,045

101.7%¥0¥6,000,045

101.7%

Total income¥16,055,586¥3,400,000¥2,067,266

60.8%¥1,000,000¥3,067,266

90.2%¥800,000¥00.0%¥0¥00.0%

JFMDA membership fee¥600,000¥600,000

100.0%¥0¥600,000

100.0%

Survey / translation costs¥600,000¥118,462

19.7%

¥0

¥118,462

19.7%

Secretariat activities¥80,000¥11,830

14.8%¥10,000¥21,830

27.3%

Subcommittees, TF activities¥400,000¥00.0%¥150,000¥150,000

37.5%

HP maintenance cost

¥0¥26,267¥0¥26,267

Others (miscellaneousexpenses)¥20,000¥5,10425.5%¥10,000¥15,104

75.5%¥5,900,000¥2,828,929

47.9%¥1,170,000¥3,998,929

67.8%

Info. exchange meeting
participation fee
Others (miscellaneous income
such as interest)

Secretariat operating
expenses (personnel expenses)
Representative meeting & info.
exchange meeting

Total spending#DIV/0!

#DIV/0!

Income and expendituresettlement in this year

¥2,001,116

This year’s carryforward¥12,156,702

Page 10#DIV/0!

#DIV/0!

(D) 2022 budget (draft)
2021 budget
Previous year carryforward
Membership fee（20万円/ 社x29）
Info. exchange meeting
participation fee
Others (miscellaneous income
such as interest)2022 Mar. FC

vs. budget

2022 budget draft¥10,155,586

FC vs. budget¥12,156,702¥5,600,000¥6,000,000

107.1%¥5,800,000

103.6%¥300,000¥00.0%¥300,000

100.0%¥0¥45

Total income¥5,900,000¥6,000,045

Total income¥16,055,586

Secretariat operating expenses(personnel expenses)
Representative meeting & info.
exchange meeting#DIV/0!

¥0101.7%#DIV/0!

¥6,100,000

103.4%¥18,256,702

113.7%

110.8%¥3,400,000¥3,067,266

90.2%¥3,400,000¥800,000¥00.0%¥800,000

JFMDA membership fee¥600,000¥600,000

100.0%¥600,000

100.0%

Survey / translation costs¥600,000¥118,462

19.7%¥600,000

506.5%

Secretariat activities¥80,000¥21,83027.3%¥80,000

366.5%

Subcommittee, TF activities¥400,000¥150,000

37.5%¥400,000

266.7%¥0¥26,267¥30,000

114.2%¥20,000¥15,104

75.5%¥20,000

132.4%¥5,900,000¥3,998,929

67.8%¥5,930,000

148.3%

HP maintenance cost
Others (miscellaneous expenses)
Total spending#DIV/0!

Income and expendituresettlement¥2,001,116¥170,000

This year’s carryforward¥12,156,702¥12,326,702

Page 11#DIV/0!