A Quick Guide On Registration & Re-Registration Of Medical Devices In Malaysia

1. To provide guidance on medical devices registration 2. To provide guidance on conformity assessment through verification route 3. To provide guidance and updates on the re- registration of medical devices 4. To provide an overview on change notification for registered medical device 5. To prove guidance on preparation of technical documentation for product registration in Malaysia 6. To familiarize participants with Medical Device Centralised Online Application 7. System (MedC@St) online application system for product registration.

1. Registration of Medical Devices-based on Regulatory Requirements in Malaysia 2. Conformity Assessment & Verification Procedure Requirements for Medical Devices Registration in Malaysia 3. MeDC@St Online Application & Case Studies 4. Updates on the Re-Registration Medical Devices & Change Notification for Registered Medical Devices