Confirm Classification: Verify that the device is correctly classified as D-class (high-risk) under Malaysian regulations. Review the MDA’s classification guidelines to ensure accurate classification.

Device Classification: Verify that your device is classified as a D-class (high-risk) medical device according to MDA guidelines.

Typically 3-6 Months: This stage involves gathering and preparing all necessary documentation, including technical files, quality management system (QMS) documentation, clinical evaluations, and risk management reports.

Determine Classification: Verify that the device is correctly classified as a D-class (high-risk) medical device based on the MDA classification criteria.

Renewal Timeline: Medical device registrations in Malaysia are typically valid for five years. Manufacturers must apply for renewal through the MeDC@St system at least 6 months before the registration expires.

Adhere to Approved Specifications: Ensure that the device remains compliant with the specifications and conditions set forth during the registration process. Any changes to the device’s design, manufacturing process, or intended use must be reported to the MDA and may require an amendment to the registration.

Verify Device Classification: Ensure that the medical device is correctly classified as a D-class device (high-risk). Misclassification can lead to delays. Check the MDA classification guidelines or consult a regulatory expert to confirm the risk level.

Before applying for D-class medical device registration in Malaysia, manufacturers and distributors must conduct thorough preparatory work to ensure compliance with Malaysian regulations and streamline the application process. D-class medical devices are considered high-risk, and preparation requires gathering comprehensive documentation and ensuring that all necessary technical and regulatory standards are met.