Confirm Device Classification: Ensure that your device is indeed classified as a Class B medical device according to the Malaysian regulatory framework. Class B devices are moderate-risk devices, so you must verify the classification through MDA's guidelines.

Registration Period: The medical device registration is valid for five years from the date of approval.

ISO 14971: This is the international standard for risk management in medical devices. It outlines the process for identifying, evaluating, controlling, and monitoring risks associated with the use of medical devices.

Device Overview: A clear and detailed description of the medical device, including its components, design, and function.

Submission Review: The initial review of your application and documents to ensure they are complete and meet MDA requirements.

Verify Device Classification: Ensure that your device is classified as Class B according to MDA’s risk-based classification system. Class B devices are those that present a moderate risk to patients and users.

Device Description: Detailed specifications, intended use, and technical information.

Device Description: Provide a detailed description of the medical device, including its design, components, and intended use.