| Time (UTC+7) | Topic |
|---|---|
| 08:30 - 09:30 | Registration |
| 09:30 - 10:10 | Opening Ceremony |
| 10:10 - 10:25 | Photo 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 |
| 1) History, Current Trend, and International Medical Devices Regulatory Forum (IMDRF) 2025 Results by PMDA Japan | |
| 2) IMDRF 2026 Activities and Future Perspective by HSA Singapore | |
| 3) ASEAN Medical Device Committee (AMDC) Activities and Work Plan 2026 - 2030 by AMDC Representative | |
| Panel Discussion | |
| 12:05 - 13:35 | Lunch Break* |
| (*participants are welcomed to visit the medical device exhibition in the Ballroom foyer during the break) | |
| 13:35 - 14:35 | [Session 2] Updating Post-Market Safety for Medical Devices and IVDs |
| 1) Post-Market Safety System in Japan by PMDA | |
| 2) Enhancing ASEAN Capacity to Ensure the Security of Diagnostic Products by ERIA | |
| 3) Establishing ASEAN Post-Market Information Sharing by MDA Malaysia | |
| Panel Discussion | |
| 14:35 - 14:45 | Break* |
| (*participants are welcomed to visit the medical device exhibition in the Ballroom foyer during the break) | |
| 14:45 - 16:15 | [Session 3] Quality Management System for Medical Devices |
| 1) Quality Management System in Japan and MDSAP by PMDA | |
| 2) Quality Management System in Indonesia by Ministry of Health | |
| 3) Quality Management System from Industry Perspective by JFMDA | |
| Panel Discussion | |
| 16:45 - 17:00 | Closing Remarks |
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:
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 - 09:30 | Registration |
| 09:30 - 09:50 | Opening 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 - 10:50 | Break |
| 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 - 13:00 | Lunch Break |
| 13:00 - 15:30 | [Session 3] Round Table Discussion |
| Presentation from each ASEAN member state delegates: | |
| Good Reliance Practice including Joint Post-Market Surveillance | |
| 15:30 - 15:40 | Break |
| 15:40 - 16:30 | [Session 4] Lecture 30 min + Q&A 20 min |
| Lecture: QMS Inspection for Medical Devices by PMDA | |
| 16:30 - 16:40 | Feedback 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 - 09:00 | Registration |
| 09:00 - 09:50 | [Session 5] Lecture 30 min + Q&A 20 min |
| Lecture: Post-Market Safety Measures (Utilization of AI) by Industry (AdvaMed) | |
| 09:50 - 10:00 | Break |
| 10:00 - 10:40 | [Session 6] Lecture 30 min + Q&A 20 min |
| Lecture: Introduction to MDSAP | |
| 10:40 -11:00 | Case Study Guidance |
| 11:00 - 11:30 | [Session 7] Case Study |
| Introduction to Case Study on Post-Market Safety Measures for Medical Devices | |
| 11:30 - 12:30 | Lunch Break |
| 12:30 - 14:00 | [Session 7] Case Study - cont’d |
| Group Discussion | |
| 14:00 - 14:10 | Break |
| 14:10 - 15:40 | [Session 7] Case Study - cont’d |
| - Group Presentation (60 min) | |
| - Wrap-up and Q&A (30 min) | |
| 15:40 - 15:50 | Feedback of Day 2 |
| 15:50 - 16:00 | Closing Ceremony and Seminar Wrap Up |
Language: English
Time Zone: Jakarta, Indonesia (Western Indonesian Time – WIB), UTC+7