Online Portal: The primary platform for submitting applications is the MeDC@St portal, managed by the MDA.

D-Class Device Fees: The fees for registering a D-class medical device can be significant due to the high-risk nature of these devices. As of the latest information, registration fees for D-class devices are generally higher compared to lower-class devices.

Classification Confirmation: Verify that your device is classified as D-class according to Malaysian regulations.

Confirm that your device is classified as D-class according to Malaysian regulations. D-class devices are those with the highest risk, such as implants or life-supporting devices.

D-Class devices are subject to rigorous regulatory controls due to their potential risks. They require detailed scrutiny to ensure their safety, effectiveness, and quality.

Understand the Classification: D-class medical devices are those with the highest risk, such as implants or devices that are used in critical care. Ensure that your device falls into this category according to Malaysia’s classification guidelines.

Activities: This phase involves preparing all necessary documentation, such as technical files, clinical data, risk management information, and labeling. The time required depends on the complexity of the device and the completeness of the documentation.

Validity Period: The registration of a Class D medical device with the SFDA is typically valid for a certain number of years. For many medical devices, this period is usually 5 years, but the exact duration can vary based on SFDA regulations and the type of device.