To apply for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), follow these steps:

1. Determine Device Classification: Confirm that your device falls under Class B as per the Medical Device Act 2012 and its regulations. Class B devices are typically low to moderate risk.

2. Prepare Documentation: Gather all necessary documents, which may include:

   • Product description
   • Evidence of safety and performance
   • Risk assessment
   • Labeling information
   • Quality management system documentation (if applicable)

3. Register with MDA: Create an account on the MDA’s online registration portal, known as the Medical Device Information System (MeDISS).

4. Submit Application: Complete the application form for Class B IVD devices and upload the required documentation through MeDISS. Ensure all information is accurate and comprehensive.

5. Pay Fees: Pay the applicable registration fees as outlined by MDA.

6. Await Evaluation: MDA will review your submission. They may request additional information or clarification.

7. Receive Approval: If the evaluation is successful, you will receive a registration certificate for your Class B IVD medical device.

8. Post-Market Obligations: After registration, ensure compliance with post-market surveillance requirements and report any adverse events as per MDA guidelines.

For the most accurate and detailed information, refer to the MDA’s official website or contact them directly.

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