B-class in vitro diagnostic (IVD) medical device registration with Malaysia’s Medical Device Authority (MDA) refers to the process of registering moderate-risk in vitro diagnostic devices, which fall under Class B according to Malaysian regulatory standards. These devices typically include tests or diagnostic tools with moderate potential risk but are not high-risk devices (like Class C or D).

Key Steps for B-Class IVD Registration with MDA

1. Classify the Device:

   • Confirm that your IVD device meets the criteria for Class B. Malaysia classifies devices into Classes A to D based on risk, with Class B being low to moderate risk.

2. Compile Documentation:

   • The necessary documents include a comprehensive technical file with details on the device’s intended use, safety and performance evidence, risk management, clinical data (if required), and labeling.
   • A Quality Management System (QMS) certificate, such as ISO 13485, is often necessary to demonstrate compliance.

3. Register via MeDISS:

   • Access MDA's online registration portal, Medical Device Information and Safety System (MeDISS). You’ll need to set up an account if you haven’t already.
   • Complete the online application, providing all required details and uploading your technical documentation.

4. Submit Fees:

   • Pay the applicable fees for Class B registration. The fee structure varies, so it’s advisable to consult the latest MDA guidelines for accurate information.

5. Await Assessment and Possible Additional Requests:

   • MDA evaluates the documentation submitted and may request additional information. This step may involve further clarification or submission of additional test results if needed.

6. Receive Registration Certificate:

   • Upon successful review and approval, MDA will issue a registration certificate for the device, authorizing its market entry in Malaysia.

7. Fulfill Post-Market Requirements:

   • Registered devices must comply with post-market surveillance requirements, including adverse event reporting and corrective action reporting if necessary.

Tips for Successful Registration

• Stay Updated: MDA’s guidelines may change, so it’s beneficial to check their website regularly or consult with a regulatory consultant familiar with Malaysian medical device laws.
• Quality Management Compliance: Ensure that your manufacturing and quality processes align with ISO 13485 standards.
• Local Authorized Representative: If you are not based in Malaysia, appoint a local representative familiar with MDA requirements to assist with regulatory matters.

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