To apply for D-class medical device registration in Malaysia, follow these steps:

1. 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.

2. Prepare Documentation: Gather all necessary documents including:

   • Device Description: Detailed information about the device and its intended use.
   • Technical Documentation: Information on the design, manufacturing, and performance of the device.
   • Quality Management System (QMS) Certificate: Typically, ISO 13485 is required.
   • Clinical Evaluation: Evidence of clinical trials or studies demonstrating safety and effectiveness.
   • Labeling: Draft labels and instructions for use.

3. Appoint a Local Authorized Representative: If your company is not based in Malaysia, you need to appoint a local authorized representative who will be responsible for communication with the Malaysian regulatory authorities.

4. Submit the Application: File your application with the Medical Device Authority (MDA) of Malaysia. You can submit your application through the MDA’s online system or by delivering the documents in person.

5. Pay Fees: There will be registration fees associated with the application. Make sure to check the current fee structure on the MDA website.

6. Review Process: The MDA will review your application, which may involve additional requests for information or clarification. Be prepared to provide any additional details they may require.

7. Approval and Registration: Once the MDA is satisfied with your submission, they will issue a registration certificate. Ensure that your device complies with any post-registration requirements, such as periodic reporting or audits.