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.

Steps to Apply for Class D Medical Device Registration with MDA:

1. Determine Classification: Confirm that your device falls under Class D as per MDA guidelines.

2. Compile Required Documentation: Prepare the necessary documents, which may include:

   • Device description and intended purpose
   • Risk management files
   • Clinical evaluation report (including clinical data and literature)
   • Manufacturing and quality control information
   • Labeling and instructions for use

3. Ensure Compliance: Your device must comply with relevant standards, such as ISO 13485 (Quality Management Systems) and any specific Malaysian standards applicable to medical devices.

4. Online Application: Create an account on the MDA’s online registration system. Fill out the application form and upload the required documents. Ensure you pay the appropriate registration fee.

5. Technical Review: Once submitted, the MDA will conduct a technical review. They may request additional information or clarification during this process.

6. Approval: If your application meets all requirements, you will receive a registration certificate. If there are issues, you will need to address them and possibly reapply.

7. Post-Market Surveillance: After registration, adhere to any ongoing monitoring and reporting obligations as stipulated by the MDA.

Additional Tips:

• It’s advisable to review the MDA's official guidelines or consult with regulatory experts for detailed and specific instructions.
• Staying updated on any changes in regulations or requirements from the MDA is crucial for a successful application.

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