EBC Medical equipment and IVD committee

Representative meeting
IVD subcommittee report
2021/12/09

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Executive summary• In 2021, we continued the activities carried out since2020 despite COVID-19, and we have requested the"system of emergency approval" and the "revision of
medical fees planned in 2022".
• In 2022, we will work toward better IVD regulationin anticipation of the next PMD act revision.
• In addition, we intend to continuously promoteevaluation of innovation for examinations toward therevision of medical fees in 2024.

Page 21. 2021 activity results⚫ Regulatory WG

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Regulatory WG: 2021 activity results summary⚫Regulatory WG• Held WG meetings 8 times（web conference）⚫Activity results of regulatory WG• Shared concerns / issues regarding the digitizationof IFU (tempu-bunsho)• Exchanged views on revising IFU (tempu-bunsho)• Exchanged views regarding cross-reagent CDx• Exchanged views regarding SaMD

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Initiatives as 3 organizations in the IVD industry

Regular opinion exchange meeting on approval review and safetymeasures for medical devices and in-vitro diagnostic reagents (27 Aug.
2021)
Collaboration Plan Working-level Meeting (13 Jan. 2022)• Confirm progress of initiatives in the new collaboration plan
Exchange of views on cross-reagent CDx••

Consider operation
Exchange views on the draft notification

Regular meetings with the Pharmaceutical Safety Measures Div. ofMHLW and the Quality Control and Safety Measures Div. of PMDA for
medical devices••Page 5

Examine change from side effect report to adverse event report
Concerns regarding IFU (tempu-bunsho) for in-vitro diagnostics reagent➢
Standardize the display method of revised parts➢
Examine “revision consultation” of IFU (tempu-bunsho)

Regular Opinion Exchange Meeting (27 Aug. 2021)@WebConstruction of a system when emerging infectious diseases
occur• Introduce a new license system in the event of an emergency

International harmonization• Promote international harmonization• International harmonization from an export perspective

Review of regulations on in-vitro diagnostic reagents• Accelerate the digitization of administrative procedures andoperations

Matters concerning law revision• Qualification requirements of person responsible for businesslicensePage 62. 2021 activity results⚫

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Reimbursement WG

Reimbursement WG: 2021 activity result summary⚫Reimbursement WG• Held WG 9 times（web conference）• Held a study session on examination in home medical care by inviting anoutside lecturer⚫Reimbursement WG activity results• Theme and strategies for medical fees revision in Reiwa 4 (2021)➢ Promoted value of POCT in home medical care / community
medical care as the key words➢ Promoted value of emergency examination that contributes tomedical outcome➢ Reviewed evaluation of malignant tumor-related genericexamination• Preparation for the a regular meeting• Preparation for statement of opinion on the industry by subcommittee
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Initiatives as 3 organizations in the IVD industry⚫ Joint medical insurance system committee with JACRI, AMDD andEBC➢ Participated in the 12 committee meetings that were held
➢ Summarized requests as an IVD industry organization regarding therevision of Reiwa 4 (2001) medical fees
➢ Responded to the government as 3 organizations in the IVD industry⚫ Exchange of opinions with MHLW (Economics / Medical Div.) for
regular meeting and subcommittee statement➢ Held opinion exchange meeting 7 times➢ Held opinion exchange meeting for malignant tumor-related genericexamination 2 times⚫ Regular meeting with MHLW and medical device industry➢ 41st regular meeting（8 Feb. 2021）➢ 42 nd regular meeting（30 Jul. 2021）⚫ Industry statements by insurance of medical materials expert
subcommittee
Page 9➢ 1st industry statement（25 Aug. 2021）➢ 2 nd industry statement（26 Nov. 2021）

Industry demands for revision of Reiwa 4 (2001)
medical fees

1.

Evaluation of in-vitro diagnostics testing①②③Evaluation based on usage results（E1,E2,E3 challenge application）
Evaluation and specification of medical usefulness/innovation
Handling of medical fees for examinations in which IVD reagent and LDTcoexist

2.

Review of malignant tumor-related generic examination items

3.

Construction of an efficient medical system by popularizing POCT
tests in home medical care

4.

Evaluation of emergency examinations that contribute to medical
outcomeContribution to realization: “Countermeasures against emerging and reemerging infectious diseases” and “Countermeasures for Antimicrobial
Resistance (AMR)”①②Page 10Enhancement of implementation system for microbiological tests
Promotion of nosocomial infection prevention measures through activeinspections

3. 2022 activity basic plan

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Activity basic plan as IVD subcommittee⚫ Collaborate with JACRI and AMDD, strengthen efforts
to the government as 3 organizations in the IVD
industry⚫ Actively participate in the activities of the 3organizations in the industry as EBC representative⚫ Make proposals led by EBC

JACRI: Japan Association of Clinical Reagents Industries
AMDD: American Medical Devices and Diagnostics Manufacture’s Association
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Regulatory WG activity plan

⚫ Promote initiatives for the second collaboration plan
➢ International harmonization of review requirements andstandards⚫ Extract and consider issues for next revision of PMDact➢ Handling classification of in-vitro diagnostic reagent➢ Scope/definition of in-vitro diagnostic reagent➢ “How it should be” - pre-approval exam
➢ Review of IVD classification⚫ Deepen understanding of overseas regulations andpromote international harmonization➢ Understanding of IVDR and VALID act.
➢ Understanding of SaMD regulations
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Reimbursement WG activity plan⚫ Strategic activities for the revision of medical fees in
Reiwa 6 (2024)➢ Appropriately evaluate and promote value of POCT tests➢ Promote value of IVD in home medical care

⚫ Consideration of preventive medicine and healthexamination for market development➢ Extract issues➢ Formulate activity policy

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