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 & Networking Breakfast |
| 2:15 PM | Welcome Address by Dr. Muralitharan Paramasua, Chief Executive, Medical Device Authority (MDA) Malaysia |
| 2:45 PM | Regulatory Update: Why GHWP Change Management Guidelines and How It Works in Managing Innovative Devices and Product Lifecycle by 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 |
| 3:15 PM | MDA New Change Management Guidance: What is Different in the New Change Management Guidance and Medcast 3.0 Application Process by En. Muhammad Hazman bin Mohd Zaini, Senior Assistant Director of Pre-Market Control Division, Medical Device Authority (MDA) Malaysia |
| 3:30 PM | Case Studies Flow Chart – Software View from Industry Assessment and Preparation for Change Based on Flow Chart by Ms Athirah Abu Bakar, Medtronic Sdn Bhd |
| 3:45 PM | Case Studies Flow Chart – Software MDA’s View on the Evaluation of the Change |
| 4:00 PM | Case Studies Flow Chart – General Medical Device by Ms Law Ching Yee, Malaysia Medical Device Association (MMDA) |
| 4:15 PM | Case Studies Flow Chart – General Medical Device MDA’s View on the Evaluation of the Change |
| 4:30 PM | Case Studies Flow Chart – IVD View from Industry Assessment and Preparation for Change Based on Flow Chart by Ms Debra Anthony Peter, Qiagen Biotechnology Malaysia Sdn Bhd |
| 4:45 PM | Case Studies Flow Chart – IVD MDA’s View on the Evaluation of the Change |
| 5:00 PM | Q&A Session and Wrap Up |