2026

The ASEAN-Japan Medical Devices Regulatory Training 2026 Provisional Agenda
MDR Symposium 2026 Schedule

Tuesday, June 30th, 2026 | Java Ballroom The Westin Hotel Jakarta

Time (UTC+7)
Topic
8:30 ‐ 9:30Registration
9:30 - 10:10Opening Ceremony Remarks

1. Mr. HIRAIWA Masaru
"PMDA Japan"
2. Prof. Dr. Hamdi Muluk, M.Si., Psikolog
"Vice Rector of Universitas Indonesia (under confirmation)"
3. Mr. CHUJO Kazuo
"Mission of Japan to ASEAN"

Keynote Speech
Mr. Budi Gunadi Sadikin
"The Minister of Health of the Republic of Indonesia"
10:10 - 10:25Photo Session
10:25 - 10:45
Press Conference and Break*
(*participants are welcomed to visit the medical device showcase in the Ballroom foyer during the break)
10:45 - 12:05
[Session 1] International Regulatory Harmonization of Medical Devices
Chair
Ms. Ayumi ENDO (PMDA) and Ms. Eva Zahrah (MoH Indonesia)
Speakers
1. Dr. Madoka MURAKAMI (PMDA)
"Overview of IMDRF and Progress 2025"
2. Ms. Annie Tan (HSA Singapore)
"IMDRF 2026"
3. Mr. Dede Mulyadi (AMDC)
"ASEAN Medical Device Committee (AMDC) New Work Plan"
Panel Discussion
12:05 - 13:35
Lunch
(*participants are welcomed to visit the medical device exhibition in the Ballroom foyer during the break)
13:35 - 14:55
Session 2: Updating Post-Market Safety for Medical Devices and IVDs
Chair
Dr. Shinichi NODA (PMDA) and Mr. Jeffri Ardiyanto (MoH Indonesia)

Speakers

1. Mr. Takumi FUKASAWA (PMDA)
“Post-Marketing Safety System in Japan”
2. Dr. Manami UECHI (ERIA)
“Enhancing ASEAN Capacity to Ensure the Security of Diagnostic Products ”
3. Ms. Nur Hazreen binti Abdul Razak (MDA Malaysia)
“Establishing ASEAN Post-Market Information Sharing”
Panel Discussion
14:55- 15:10
Break
(*participants are welcomed to visit the medical device exhibition in the Ballroom foyer during the break)
15:10 - 16:30
Session 3: Quality Management for Medical Devices
Chair
Dr. Madoka MURAKAMI (PMDA) and Ms. Siti Sari Septiani (MoH Indonesia)

Speakers

1. Dr. Yutaku KANETA (PMDA), 15min
“Quality Management System in Japan and MDSAP”
2. Ms. Eka Purnamasari (MoH Indonesia), 15min
“Quality Management System in Indonesia”
3. Dr. Yoko YOSHIDA (JFMDA) 15min
“Quality Management as Industry”
Panel Discussion (35 min)
16:30 - 16:40
Closing Ceremony

Prof. apt. Silvia Surini, M.Pharm.Sc., Ph.D.
The Dean of the Faculty of Pharmacy Universitas Indonesia

 Language: English
Time Zone: Jakarta, Indonesia (Western Indonesian Time – WIB), UTC+7
*The exhibition will be held in parallel with the Symposium. All symposium participants are invited to explore the following exhibition which will be conveniently located adjacent to the main venue:

  • a showcase of Indonesia health products (medical devices, IVDs, traditional medicine/Jamu),
  • free health check with locally-manufactured products
  • consultation service for medical device registration and inspection in Indonesia
  • Indonesia Health Tourism showcase
  • medical device research posters

SEMINAR (DAY 1), July 1st, 2026
(For invited delegates from the regulatory authorities of ASEAN Member States (AMS) only)

Time (UTC+7)Topic
09:00 - 09:30Registration
09:30 - 09:50Opening Ceremony and Photo Session
09:50 - 10:40[Session 1] Lecture 30 min + Q&A 20 min

Lecture: Overview of Post-Market Safety Measures for Medical Devices in Japan by PMDA
10:40 - 10:50Break
10:50 - 11:40[Session 2] Lecture 30 min + Q&A 20 min

Lecture: Medical Device Regulatory Reliance Programs by IMDRF GRRP Working Group
11:40 - 13:00Lunch Break
13:00 - 15:30[Session 3] Round Table Discussion

Presentation from each ASEAN member state delegates.

Regulatory Updates of QMS and Post-Market Safety
15:30 - 15:40Break
15:40 - 16:30[Session 4] Lecture 30 min + Q&A 20 min

Lecture: QMS Inspection for Medical Devices by PMDA
16:30 - 16:40Feedback of Day 1

Language: English
Time Zone: Jakarta, Indonesia (Western Indonesian Time – WIB), UTC+7

SEMINAR (DAY 2), July 2nd, 2026
(For invited delegates from the regulatory authorities of ASEAN Member States (AMS) only)

Time (UTC+7)Topic
08:30 - 09:00Registration
09:00 - 09:50[Session 5] Lecture 30 min + Q&A 20 min
Lecture: Post-Market Safety Measures by Industry (AdvaMed)
09:50 - 10:00Break
10:00 - 10:40[Session 6] Lecture 20 min + Q&A 20 min

Lecture: Introduction to MDSAP
10:40 -11:00Case Study Guidance
11:00 - 11:30[Session 7] Case Study

Introduction to Case Study on Post-Market Safety Measures for Medical Devices
11:30 - 12:30Lunch Break
12:30 - 14:00[Session 7] Case Study - cont’d

Group Discussion
14:00 - 14:10Break
14:10 - 15:40[Session 7] Case Study - cont’d

- Group Presentation (60 min)
- Wrap-up and Q&A (30 min)
15:40 - 15:50Feedback of Day 2
15:50 - 16:00Closing Ceremony and Seminar Wrap Up

Language: English
Time Zone: Jakarta, Indonesia (Western Indonesian Time – WIB), UTC+7