Date: 27 August 2026 (Thursday)
Time: 2:00 pm – 5.30 pm
Venue: Stage 1, Hall 5, KL Convention Centre, KLCC
| TIME | AGENDA |
| 2.00 PM | Registration |
| 2.15 PM | Welcome Address and Opening by AMMI & MMDA |
| 2.30 PM | Regulatory Update: GHWP Change Management Guidelines and Managing Innovative Devices and Product Lifecycle How the new way of change management can cater to new and innovative devices. Speaker: Mr Sharad Mi. Shukla Chairperson, Regulatory Affairs Committee, APACMed and Director Regulatory Affairs, MedTech (Lead APAC Digital Regulatory Policy & SEA Regulatory Affairs) Johnson & Johnson MedTech |
| 3.00 PM | MDA New Change Management Guidance What is the difference between the new change management guidance, and Medcast 3.0 application process. Speaker: Ms Aidahwaty M. Olaybal Senior Director, Pre-Market Control Division, Medical Device Authority, Ministry of Health, Malaysia |
| 3.30 PM | Coffee Break |
| 3.45 PM | Case Studies Flow Chart – General Medical Device View from industry assessment and preparation for change based on the flow chart Speaker: Abbott |
| 4.00 PM | Case Studies Flow Chart – General Medical Device View from MDA in the evaluation of the change Speaker: MDA |
| 4.15 PM | Case Studies Flow Chart – IVD View from industry assessment and preparation for change based on the flow chart Speaker: Qiagen (TBC) |
| 4.45 PM | Case Studies Flow Chart – Software View from industry assessment and preparation for change based on the flow chart Speaker: Medtronic (TBC)
|
| 5.00 PM | Case Studies Flow Chart – Software View from MDA in the evaluation of the change Speaker: MDA |
| 5.15 PM | Q&A |
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