Confirm that your device is classified as Class D based on MDA classification criteria.

MDA Official Website: Visit the official website of the Medical Device Authority of Malaysia at www.mda.gov.my.

The cost and time required to obtain Class D medical device registration with the Medical Device Authority (MDA) in Malaysia can vary based on several factors, including the specific device, the completeness of the application, and whether any additional information is required during the review process.

Confirm that your device is classified as Class D according to MDA classification criteria.

Confirm that your device is categorized as Class D according to MDA guidelines.

Class D medical devices in Malaysia are classified as high-risk devices that are critical to health and safety. These can include devices such as implantable devices, active devices that are invasive, and devices that support or sustain life. Due to their risk level, they require a more rigorous registration process.

Determine Device Classification: Confirm that your device is classified as Class D according to the MDA classification system.

Duration: This phase can vary significantly based on how quickly you can gather and prepare the necessary documentation, including the technical file, risk management documentation, and quality management system evidence. This could take anywhere from a few weeks to several months, depending on the complexity of the device and the completeness of the existing documentation.