Special Access Medical Device
- Guidance Document Special Access-Requirements For Ventilator During Emergency Situation
- Guidance Document Special Access-Notification-General Requirements
- Disposal Of Medical Device For Special Access
- Notification Of Unregistered Medical Devices For Special Access Route A Form
- Notification Of Unregistered Medical Devices For Special Access Route B Form
- Flowchart Of Evaluation For Special Access Application For IVD Medical Devices During COVID-19 Emergency
- Supporting Documents for COVID-19 IVD Test Kits Special Access Notification
- For submision or any inquiries please email to sa.cm @ mda.gov.my
- Officer Incharge :
- Puan Aidahwaty - +603 - 8230 0341
- Puan Norlela - +603 - 8230 0342
- Encik Mohd Naquib - +603 - 8230 0209
Latest Updates :
1. Expert IVD Evaluation Committee Meeting is scheduled to be held on 4th February 2021, Thursday (cut-off date : 29th January 2021, 5:00pm)
2. In order to prevent email deliverability issues due to platform migration of myGovUC email to a new platform, please submit Special Access Notification to sa.cm@mdb.gov.my.
