To apply for a B-class in vitro diagnostic (IVD) medical device registration with Malaysia’s Medical Device Authority (MDA), follow these steps. The application is processed entirely through MDA’s online platform, known as the Medical Device Information and Safety System (MeDISS). Here’s how to proceed:

Steps to Apply for B-Class IVD Medical Device Registration

1. Verify Device Classification:

   • Ensure your device qualifies as a Class B (low-to-moderate risk) IVD device based on MDA’s classification rules, which consider the intended use, risk level, and invasiveness.

2. Prepare Required Documents:

   • Gather the necessary documentation, including:
     • Device Description: Comprehensive details about the device’s purpose, function, and components.
     • Risk Management Report: Risk analysis as per ISO 14971, with risk identification and mitigation strategies.
     • Performance Evaluation Data: Clinical and non-clinical data demonstrating the device’s safety and effectiveness.
     • Labeling and IFU: Include detailed labeling and instructions for use.
     • Quality Management System (QMS) Certification: ISO 13485 certificate, demonstrating that the manufacturing facility meets QMS standards.
     • Declaration of Conformity: A document signed by the manufacturer confirming compliance with Malaysian regulations.
   • Ensure these documents are complete, clear, and saved in PDF format for easy upload to MeDISS.

3. Create an Account on MeDISS:

   • Go to the MeDISS website and create an account if you do not already have one. For foreign manufacturers, a local authorized representative (AR) registered with MDA is required to complete this process and manage regulatory compliance in Malaysia.

4. Submit Application Through MeDISS:

   • Log in to MeDISS and select Class B IVD Device Registration. Fill out the application form with the required details and upload your prepared documents.
   • Carefully review each section to ensure all required fields are completed accurately and documents are attached correctly.

5. Pay Registration Fees:

   • Upon completing the application, you’ll be prompted to pay the registration fees. Payment can be done directly through MeDISS. Fee amounts vary based on the device class and are updated in MDA’s fee schedule.

6. Monitor Application Status:

   • After submission, track your application status on MeDISS. MDA may request additional information or clarifications, so monitor your account and respond promptly to any notifications to avoid delays.

7. Receive Approval and Certificate:

   • Once approved, MDA will issue a registration certificate through MeDISS, authorizing your Class B IVD device for the Malaysian market. The certificate is generally valid for five years and must be renewed before expiration to maintain market access.

Processing Location

The entire application process is conducted online through the MeDISS platform. There is no physical submission required unless specified otherwise by MDA.

For further assistance:

• Website: https://www.mda.gov.my
• MeDISS Portal: https://mediss.mda.gov.my
• Contact MDA: Reach MDA for questions via phone (+603-8230 0300) or email (mdb@mda.gov.my).

Following these steps will help streamline your B-class IVD registration process with MDA.

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