Page 1

EBC Medical Devices and IVD Committee

Board of Representatives

Report of the Regulatory Affairs Committee
16:20-16:40 on December 8, 2022
Vice Chairman: Takeshi Fujiwara
Committee Chairman: Miyo Nishimuta

Report of the Regulatory Affairs Committee
AGENGA

Page ‹#›2▪ Activity Report 2022
▪ 2023 Activity Policy▪ < Recent trends in Regulatory Affairs >▪ 20th Regular opinion exchange meeting on Approval Examination of medical devices and IVD and safetymeasures (September 1)➢ Materials submitted by the MHLW
- Activities on accelerating the review of the approval of medical devices “AI IDATEN”- Implementation of the revised Drugs and Drugs Act. “UDI”➢ Materials submitted by the PMDA
- Operational achievements in FY2021- The Online system for applications and notifications- Business Conditions of Program Medical Devices, etc.
▪ 3rd Government-Industry Dialogue for the Creation of Innovative Medical Devices (November 28)➢ Materials submitted by European Business Association Medical Device and IVD Committee (EBC)- My Number Card

Report of the Regulatory Affairs Committee on activities Jan-Dec 2022
Total number of meetings 123◼ Medical Device Cyber Security WG (9 times)

Page ‹#›3◼ Regulatory Affairs Committee (6 times)
Review-related sub-committees (5 times)◼ Program Medical Device Regulation SubWG (12 times)
Consider ensuring transparency in the review process TF (6 times)

Good Advertising Standards Interpretation WG (5 times)
Consideration of revision of raw material notifications due to changes in raw
material safety assessment methods (4 times)◼ Program Medical Device WG Insurance Compliance SubWG (3 times)◼ Clinical Evaluation Committees (8 times)
Clinical Regulation Subcommittee
T3: Protection and Education of Subjects WG (6 times)
T4: Clinical Evaluation WG (3 times)
T5: RWD/RWE Utilization Study WG (twice)
CIN registry study Group (6 times)◼ UDI committees (5 tumes)◼ QMS Committee (6 times)◼ Package Insert Operation Improvement WG (5 times)◼ Standards subcommittee (4 times)◼ Health and Labour Sciences Research: QMS (7 times)
Health and Welfare Sciences Research: Requirements
for the General manufacturing and sales manager (2 times)◼ Human Resources Project for Mirai (7 times)◼ Collaboration for Optimization of Medical Device Regulations and Approval Examination (January 13, July 14)■ Tripartite Meeting (4 times)◼ 20th Regular opinion exchange meeting on Approval Examination of medical devices and IVD and safety measures (September 1)◼ 3rd Government-Industry Dialogue for the Creation of Innovative Medical Devices (November 28)

Thank you all for your very busy schedules.

The Regulatory Affairs Committee’s 2023 Activity Policy
Page ‹#›4

We propose the appropriate and optimized medical device review and regulatory systems
through meetings with government authorities and industry activities related topharmaceutical affairs.

Reference 1

20th Regular opinion exchange meeting on
Approval Examination of medical devices and IVD
and safety measures
Materials submitted by the MHLW

September 1, 2022
5

Activities on accelerating the review of
the approval of medical devices

6

DASH for SaMD (Packaging strategies to accelerate the practical application of the program medical devices.)

3. Introduction of an approval system according to the characteristics of medical devices○

Introduction of an approval review system that enables continuous improvement by checking the plan forthe medical device expected to be improved* during the review process and allowing partial changes to bemade within the planned scope.
* Medical devices that constantly change performance after marketing, such as medical devices that utilize AI, medical devices that use realworld data collected after marketing (RWD: real-world data), and additional optional parts to improve usability is assumed.
Procedures for the expansion of the current
indication
Collection ofclinical dataSub
missi ExaminationonAfter gathering all the necessary data,
apply for partial changes in approval
App
roval

Development of change plans
for additional indications, etc.

Collection ofdata

Procedures for Expansion of Indications Using Change
Plans
Collection ofclinical data

Sub
missi
on

Development ofchange plans for
additional
indications, etc.

Examination

Submission ofchange plan

PartialChangeSubmission

Changeapproval
contents.

Examination

Additional
indications,etc.

With the pre-planned results
Check whether they have been obtained

App
roval

Early realization of
improvements
PartialChangeSubmission

Conf Data collection
irmat according to the plan
Check
ion
PartialChangeNortification

Changeapproval
contents.

Additional
indications,etc.

Advance
Confirmation System for Improvement Plans
・Changes in size, components,
performance, etc.
IDATEN(Improved Design within Approval for Timely Evaluation and Notice)10

The overall picture of Program Medical Devices Based on previous approvals (Update Version)
Non-medical device
Not intended for the diagnosis,
treatment /Equivalent to “Class I”*(Behavior Change Applications)Hypertension treatment aids app→Aids hypertension treatment through behavior
changeMedical devices
Class IIClass IIIClass IV

For treatment
For the health management Program(Example: programs that provide
advice on diet, and exercise tomaintain and improve health)

Educational program(Example: Training programs forhealth professionals)
In-hospital operational support
program(Example: medical appointments,
electronic medical records)“Class I” equivalent program(Example: programs for vision
testing and color vision testing)Treatment planning support

Programmer for
implantable therapeutic
devices
Behavioral change
application

61 items

2 items(Diagnostic Imaging Support)
The endoscopic imaging assistance program→Polyp detection to warn and assist in the detectionof lesions.

2 items

For diagnostic purposes
Diagnostic imaging support

301 items

Diagnostic support
other than diagnostic imaging support

85 items

Mutational analysis
Diagnostic Support for
Home Use

2 items*Stand-alone programs equivalent to “Class I” are non-medical devices.
*Total number of approved and certified products (as of the end of September 2022)

7 items(Diagnostic Support for Home Use)
Home electrocardiogram application→Detects signs of atrial fibrillation and recommends
hospital visits.

Implementation of therevised Drugs and Drugs Act.

9

Improving traceability
Current status○ By displaying barcodes on pharmaceuticals and medical devices, it is possible to construct a producttraceability system, which is expected to be used in distribution and in medical practice. In recent years,
efforts for standardized bar code labeling and utilization have been promoted both in Japan and overseas.
<Display GS1 standard bar code on pharmaceuticals and medical devices>
GS1-128 symbol (code 128)

<Register product information in database>→Information other than the product code can be added as
an international standard.

UBD

Product code

Pharmaceuticalproducts
Standard code
masterLot No.

Medical devices
Database

Major information that can be displayed in GS1-128(01)

Product code (GTIN/JAN)→ Unique codes: manufacturer, product, packaging units(11)

Date of manufacture(17)

UBD: Expiration date(10)

Lot No.

(21)

Serial number(30)

Quantity

Use of bar codes in logistics and medical facilities○Efficiency of logistics management○In-hospital inventory management○Improvement of medical safety(Prevention of mishandling, identification of recall lots, etc.)※Determine the meaning of code by the number in the first parenthesis.

Manufacturing
companies

Wholesaletrade

Hospital

Logistics management
division

Clinical department
Electronic health record
systemAccess image from GS1 code to the package insert
Code<GS1 code>

Loaded code:
0XXXXXXXXXXXXX

Read GS1 code information using the apps.
The URL of the redirect page is generated
from the GS1 code.

Look at the package insert.

Package insert navigation system
Look at the relevant
documents

https://www.pmda.go.jp/PmdaSearch/bookSearch/
01/0XXXXXXXXXXXXX

The package insert will be displayed.

○

Exceptions to the display of codes on the packaging are permitted for types of drugs and medical devices.
✔ Drugs and medical devices that cannot be coded because of the small area
✔ Large medical equipment✔ Stand-alone medical device program etc.

20th Regular opinion exchange meeting on
Approval Examination of medical devices and
IVD and safety measures
Materials submitted by the PMDA

Independent administrative institution
Pharmaceuticals and Medical Devices Agency
Pharmaceuticals and Medical Devices Agency

12

Operational achievements in FY2021○

Review Period and Number of Approvals in FY2021
Breakdown

Medicaldevices

New medical device(Priority)

Total review period
and number(Actual results)

Total review period and numberof the COVIT-19 related products(Actual results)

10.0 months(80% tile value)

8.9 months

―

1

0

14.0 months(80% tile value)

11.9 months

―

33

0

10.0 months(60% tile value)

8.8 months

2.1 months

43

2 Note 1

6.0 months(60% tile value)

5.7 months

3.9 months

208

3 Notes 2

4.0 months(60% tile value)

3.6 months

0.2 months

737

3

Specialized
Consultations, etc.
Products

12.0 months(60% tile value)

6.2 months

3.1 months

93

49

General Products

7.0 months(80% tile value)

6.3 months

4.6 months

67

2

New medical device(Normal)Improved medical
devices(with clinical data)
Improved medical
devices(w/o clinical data)
Me-too device

IVD

Total review period(Target)Note 1: Related to the COVID-19 pneumonia image analysis support program.

Note 2: Ventilators, etc.

Note 3: General syringe with needle

13The On-line system forapplications and notifications

14

The Online system workflow for applications, notification
Paper-based submissions
and notifications are still
possible.
▌ ① T h e a p p l i c a n t d o wn l o a d s t h e a p p l i c a t i o n s o ft wa r e

Online reception is available for
Notification: Started in July 2021
Submission: Scheduled to start during FY2022 (see next page).

▌ ② Prepare application, notification, and other documents▌ ③ Online submission for applications and notifications to the Pegasus system using the gateway system (submit application infor mation and attached documents)▌ ④ Information sent to the Pegasus system is viewed, reviewed, and investigated by the contact person.
▌ ⑤ For the results of the business license and approval review, a business license and approval letter are issued (in paper medi a).
FD Application
WebsiteDatabaseserverPegasus system

Terminal
serverInternet① Downloads theapplication software
Gateway system

Medical devicecompanies③ Online submission
for applications andnotifications④ Review andPMDA
Investigation
Client PC (remote desktop connection)② Preparation of
application/notification

Dedicated
network lines④ Review,
MHLW
etc.
Client PC (remote desktop connection)④ Review,
etc.

Prefectures (47)
Client PC (remote desktop connection)... Flow of procedures... New information flow

Regional Bureaus of
Health and Welfare (7)Client PC (remote desktop connection)④ Review,
etc.

15

Timing of the start of online submission
Classification

Onlinesubmission

1.Medical devices
・ New medical device

July 2022

・ Improved medical devices (with clinical data)

July 2022

・ Improved medical devices (w/o clinical data)

October 2022

・ Me-too device

January 2023

2.IVD
・ New product

July 2022

・ Non-conforming product to approval standards (with clinical data)

July 2022

・ Product out of the approval criteria (with clinical data)

July 2022

・ Product out of the approval criteria (w/o clinical data) [New file product only]

October 2022

・ Products within approval criteria

January 2023

・ Non-conforming product to approval standards (w/o clinical data)

January 2023

・ Product out of the approval criteria (w/o clinical data) [Partial amendment only]

January 2023

3.Others
・ Other than the above (Re-examination, User performance evaluation, IDATEN)

January 2023

◎ On-line submission for reliability and QMS inspections started in July 2022
16

Business Conditions ofProgram Medical Devices, etc.

17

DASH for SaMD (Package Strategy for Accelerating the Commercialization of Program Medical Devices)Centralized consultation desk for program medical device
1. Consultation on the applicability of the medical device(Compliance and Narcotics Division, Pharmaceutical
Safety and Environmental Health Bureau, MHLW)

Centralized consultationdesk• PMDA Review
Management Division••

Clarification of decisions
Publication of cases

Consulter
Collaboration

Introduction to thecorresponding
consultation service,depending on the
topic of theconsultation.

2. Pharmaceutical development consultation(PMDA Program Office of Medical Devices)

Collaboration
3. Medical insurance consultation

•
•
•
•

Targets companies that plan to develop program medical devices.
It is also possible to receive the consultation from 1 to 3 directly
without going through the centralized consultation desk.
Apply for consultation using the same application form for
consultations 1-3.
Free of charge(Policy Planning Division for Pharmaceutical Industry
Promotion and Medical Information Management,
Health Policy Bureau, MHLW)The number of consultations received *Multiple consultations are possible per application.

Overall

238 cases

1. Applicable Consultation

175 cases

2. Development consultation

110 cases

3. Medical insurance consultation

43 cases※Data from April 2021 to the end of March 2022

8

Changes in the Number of Approvals of Program Medical Devices by YearAs of the end of March 2022

 Program medical devices were newly defined according to the "Act on Quality, Efficacy and Safety Assurance ofPharmaceuticals and Medical Devices" promulgated on November 27, 2013 (effective November 25, 2014).
 Program Medical Device (Definition):
A device intended to be used for diagnosis, treatment, or prevention of human diseases or to affect the structure or function of
the human body in a tangible form installed in a general-purpose computer, mobile information device, etc.
However, programmed medical devices are excluded from the scope of medical devices if there is little risk of affecting humanlife and health in the event of functional impairment, etc.

19

Status of Approval of Medical Devices (Programs) Utilizing AI (as of the end of April 2022)
Company who haveobtained manufacturingand marketing approval

No.

Approval
Date / Partial
Change Date1

H30.12.6

Endoscopic imaging support software
EndoBRAIN

Cybernet Systems Co., Ltd.

Ultra-Extended Endoscopy to Determine Tumor/NonTumor Colorectal Lesions

2

R1.9.17

EIRL medical image analysis software
Aneurysm

Elpixel Stock Association
Company

From an MRI head angiogram to an aneurysmal artery
Assisting in detecting candidate points similar to
deformation

3

R1.12.25

Similar image case search software FSCM687

Fujifilm sharesCompany

Analyze the target area for diagnostic images (worshipnodules/diffuse disease/liver mass) from X-ray CT
images and assist in retrieving similar images from thedatabase of the institution in use

4

R2.4.27

Endoscopic imaging support software
EndoBRAIN-UC

Cybernet Systems Co., Ltd.

5

R2.5.8

Pulmonary nodule detection program FS-AI688

6

R2.6.3(R2.8.11)

7

R2.6.19

8

Brand name

COVID-19 Pneumonia Image Analysis AI
Program InferRead CT Pneumonia※The brand name was changed at the time of
the change.

Fujifilm sharesCompany

Product overview, etc.

Supporting the display of the degree of inflammation(activity/remission) in ulcerative colitis from ultramagnified endoscopic images
X-ray CT image to help detect possible pulmonary nodular
shadows

CES Carto Co., Ltd.

3 levels of confidence to assist in the display of thepotential imaging findings from X-ray CT images in
COVID-19 pneumonia

AI-Rad companion

Siemens Healthcare Co., Ltd.

X-ray CT image to help detect possible pulmonary nodular
shadows

R2.6.29(R3.3.29)

Endoscopic Imaging Support Program
EndoBRAIN-EYE

Cybernet System
Mu Corporation

Detection of the Presence of Colorectal Polyps from
Endoscopic Images
Support

9

R2.6.29

Ali-M3, a COVID-19 pneumonia image
analysis program

MIC Medical, Inc.

3 levels of confidence to assist in the display of thepotential imaging findings from X-ray CT images in
COVID-19 pneumonia

10

R2.7.15

Endoscopic imaging support software
EndoBRAIN-Plus

Cybernet Systems Co., Ltd.

Support for Pathological Prediction of Colorectal Lesions(Non-Tumor/Adenoma/Mucosal Cancer/Invasive Cancer)

20

Status of Approval of Medical Devices (Programs) Utilizing AI (as of the end of April 2022)
No.

Approval
Date / Partial
Change Date

11

R2.8.20

12

R2.9.213

R2.11.24

14

Brand nameCompany who haveobtained manufacturingand marketing approval

Product overview, etc.

EIRL X-Ray Lung node medical image
analysis software

ELPIXEL CO., LTD.

Help detect possible pulmonary nodular shadows from chest
radiographs

Endoscopy support program EW10-EC02

Fujifilm Corporation

Endoscopic Imaging to Assist in Detection and Differential
Diagnosis of Colorectal Polyps

RN-Deca Breast Cancer Diagnosis Support
ProgramToe

CES DECALL Co., Ltd.
To

Ultrasound of the breast helps detect potential lesions

R2.11.30

WISE VISION Endoscopic Image Analysis AI

NEC Corporation

Endoscopic images to assist in the diagnosis of precolonic andearly colorectal cancer lesion candidates with a grossappearance of elevated type15

R3.5.26

C О VID-19 Pneumonia Image Analysis
Program FS-AI693

Fujifilm Corporation

3 levels of confidence to assist in the display of the potential
imaging findings from X-ray CT images in COVID-19
pneumonia

16

R3.7.7

Chest radiographic lesion detection (CAD) plog
Ram LU-AI689

Fujifilm sharesCompany

Chest X-ray image showing abnormal findings such as
pulmonary nodules and pneumothorax
Support for detection of candidate shadows

17

R.3.9.1

Rib fracture detection program FS-AI69, Type1

Fujifilm Corporation

Support for detection of potential rib fractures from X-ray CT
images18

R3.10.11

Imaging support software KDSS-C XR-AI-101

Konica Minolta Co., Ltd.

Support for the detection of possible abnormal findingssuch as lung nodules and lung masses from chest X-ray
images19

R3.12.9

Chest X-ray pneumonia detection engine
DoctorN
Et JLK-CRP

Doctor Inc.
Net

Radiographic evidence of infectious pneumonia from chest
radiographs
Assisting labeling of possibilities with three levels of confidence

20

R3.12.24

Fujitsu Japan Limited

3 levels of confidence to assist in the display of the potential
imaging findings from X-ray CT images in COVID-19
pneumonia

HOPE Life Mark-CAD Image Analysis
Support Program for COVID-19

21

3rd Government-Industry Dialogue for
the Creation of Innovative Medical Devices

November 28, 2022
EBC Medical Devices and IVD Committee
Medical Fee Committee and Pharmaceutical Affairs Committee
Page 22

2. Medical DX - Expansion to support system of telemedicine and medical monitoring
1. Current Status - Telemedicine Support System• Online medical consultations, which were delayed compared to overseas, have been expanded as an emergency response to COVID-19, improving convenience for patients.
Further expansion is expected. In particular, the diagnosis and treatment of Doctor to Doctor by remote control overseas is globalizing and spreading. On the other hand, inJapan, diagnosis is only a tool for instruction of operation by remote communication. Ex.: Only ordering from the doctor at the outside facility to the operating technician at thefacility where the device is installed• Utilization of these technologies is consistent with improving the quality of medical care, ensuring its accessibility, and maximizing therapeutic effects through active
involvement with patients who need treatment. In the social issues such as population decline and a decrease in the number of surgeons, telesurgery will contribute to thestandardization of high-quality medical care, and in addition, it will contribute to public welfare by improving medical standards. It is also expected to have the effect ofpromoting technological development in related fields in Japan.
• Therefore, it will greatly contribute to the shortage of doctors in Japan and the standardization of medical care.
2. Current Status - eHealth and Related• Although digital health (eHealth) is not progressing as compared to Europe, its development is expected, and in Japan, the expansion of PHR to medical care has been stipulated
as a basic policy (HONEBUTO) medical DX. Related to this is the utilization and sharing of patient information. In particular, sharing information for patients with implanted
medical devices can be a challenge.

Request ; Further promotion of telemedicine and digital health• Although deregulation is progressing toward the realization of telemedicine, we ask that you continue to discuss deregulation, etc., toward concrete realization in clinicalsettings.
(Ex.: D-D operation/manipulation support system of remote treatment, D-D imaging support system of remote diagnostics etc.)• In order to realize eHealth, we would like to set up a forum for joint consultations between the public and private sectors so that concrete actions can be taken.
• Integration of implantable medical device information into systems: It is expected that information such as the patient notebook will be incorporated into my number card.
MRI examinations of patients with implanted devices such as cochlear
implants, cerebral aneurysm clips, and coronary artery stent are sometimes
performed without specifying the material or manufacturer, as the patient's
declaration of examination is ambiguous.
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[Reference materials]

Medical DX Integrating Information on Implanted Medical Devices to My Number Cards
System to confirm the information of implanted devices at medical institutions nationwide
A system to confirm the information of implantable medical devices at medical institutions nationwide in order to avoid accidents at the timeof emergency or MRI imaging, or when changing hospitals Please expand the scope of information subject to My Number card registration to
include information on implantable devices Implantable device
Patient record bookPatient
information

MRI card

notebook

System to allow viewing of own implantable device information
Access by citizens and patients to their own information on implanted devices via PCs,
smartphones, etc. ・ A system that enables use

Digital Tracking of Designated Medical Devices
When medical devices are collected, the medical institution inquires about the implantable device information from the lot number (information included in UDI) published by thecompany to the operator, and the operator responds to the patient information online. From the viewpoint of privacy protection, it is possible to limit the database of patient informationin companies.
Registration of implantable device information

Browsing patient information and implanted
device information

Online Qualification Confirmation System

MedicalInstitutionA

contact
Individual unit insured number and specifichealth checkup data, Drug information, etc.
1:1

Providing collection
information to medical
institutions

Patient
Identity confirmation
Displaying
Information

Surgery / transplantation, dialysis, names of medical institutions, etc.

Browsing implanted medical device information at the time of hospital transfer/emergency
Page 5Company

MedicalInstitution B