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
Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
2. Prof. Ir. Mahmud Sudibandriyo, M.Sc., Ph.D.
Vice Rector for Academic and Student Affairs of Universitas Indonesia
3. Mr. CHUJO Kazuo
Chargé d'Affaires ad interim of Japan to ASEAN

Keynote Speech
Dr. L. Rizka Andalusia, Apt., M.Pharm, MARS
Director General of Pharmaceutical and Medical Devices, Ministry 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
1. Ms. ENDO Ayumi
Office Director, Officer of Asia Training Center and International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
2. Ms. Eva Zahrah
Head of Team for Evaluation of Distributor License, and Specific Medical Device, Ministry of Health of the Republic of Indonesia

Speakers

1. Dr. MURAKAMI Madoka (PMDA)
Deputy Division Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
"Overview of IMDRF and Progress 2025"

2. Ms. Annie Tan (HSA Singapore)
Director of Medical Devices Cluster, Health Sciences Authority (HSA) Singapore
"International Medical Device Regulators Forum (IMDRF) 2026"

3. Mr. Dede Mulyadi (AMDC)
Director of Production and Distribution of Medical Devices, Ministry of Health of the Republic of Indonesia
"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
1. Dr. NODA Shinichi
Head of Asia Office, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
2. Mr. Jeffri Ardiyanto (MoH Indonesia)
Director of Pharmaceutical and Medical Device Resilience, Ministry of Health of the Republic of Indonesia

Speakers

1. Mr. FUKASAWA Takumi (PMDA)
Inspector, Office of Vigilance and Standards for Medical Devices, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
"Post-Marketing Safety System in Japan"

2. Dr. UECHI Manami (ERIA)
Director of Health and Social Welfare ERIA (Economic Research Institute for ASEAN and East Asia)
"Enhancing ASEAN Capacity to Ensure the Security of Diagnostic Products"

3. Ms. Nur Hazreen binti Abdul Razak (MDA Malaysia)
SENIOR ASSISTANT DIRECTOR 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
1. Dr. MURAKAMI Madoka
Deputy Division Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
2. Siti Sari Septiani (MoH Indonesia)
Health Administrator in the Ministry of Health, Republic of Indonesia

Speakers

1. Dr. KANETA Yutaku (PMDA), 15min
Division Director, Office of Compliance and Manufacturing Quality for Medical Devices, Pharmaceuticals and Medical Devices Agency (PMDA) Japan
"Quality Management System in Japan and MDSAP"

2. Ms. Eka Purnamasari (MoH Indonesia), 15min
Director, Ministry of Health of the Republic of Indonesia
"Quality Management System in Indonesia"

3. Dr. YOSHIDA Yoko (JFMDA) 15min
Manager, Global Quality Management, Nihon Kohden Corporation & Japan Federation of Medical Devices Associations (JFMDA)
"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

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