Processing the registration of a B-class in vitro diagnostic (IVD) medical device with Malaysia's Medical Device Authority (MDA) involves a structured approach that includes several steps, from preparation to submission and follow-up. Below is a comprehensive guide on how to process the registration:

Steps to Process B-Class IVD Registration with MDA

1. Determine Device Classification

• Confirm that your device qualifies as a B-class IVD according to the MDA classification criteria. This can involve consulting MDA's classification guidelines.

2. Prepare Documentation

• Technical Documentation: Gather all necessary documentation, including:
  • Device Description: Detailed information on the device, its intended use, and target population.
  • Performance Evaluation: Data demonstrating the performance and safety of the device (clinical and non-clinical data).
  • Risk Management: Documentation following ISO 14971 that identifies and mitigates potential risks associated with the device.
  • Labeling and Instructions for Use: Draft and prepare labels and user instructions that comply with MDA requirements.
• Quality Management System (QMS): Ensure compliance with ISO 13485 and document your quality management practices.

3. Create an Account on the MDA Portal

• Register for an account on the MDA’s online registration portal (e-Submission system). This will be used for all submissions and communications with MDA.

4. Complete the Application Form

• Fill out the B-class IVD registration application form on the MDA portal. Provide accurate and complete information to avoid delays in processing.

5. Upload Required Documents

• Upload all required documents, including:
  • Technical documentation.
  • Clinical evaluation data.
  • Risk management documentation.
  • Labeling and IFU.
• Ensure documents are formatted as per MDA specifications (e.g., PDF, Word) and that they are complete.

6. Submit the Application and Pay Fees

• Submission: Submit the application through the MDA portal.
• Payment: Pay the registration fees online as specified by MDA. Keep the payment receipt for your records.

7. MDA Review Process

• Initial Review: MDA will conduct an initial review to check for completeness.
• Technical Evaluation: MDA will evaluate the safety, performance, and compliance of the device based on the submitted documentation.
• Request for Additional Information: Be prepared to respond to any requests for additional information or clarification from MDA promptly.

8. Manufacturing Site Inspection (if applicable)

• If required, MDA may conduct an inspection of the manufacturing facility to ensure compliance with quality standards. Ensure the facility is prepared for inspection and that all relevant documentation is available.

9. Receive Approval

• If the application is approved, MDA will issue a registration certificate, allowing the device to be marketed in Malaysia.
• If the application is rejected, MDA will provide reasons for rejection and may allow for re-submission after addressing the identified issues.

10. Post-Market Surveillance and Compliance

• After registration, implement a post-market surveillance (PMS) plan to monitor the device's safety and performance in the market.
• Maintain your QMS and prepare for periodic reviews, audits, and potential renewal of registration as needed.

Summary of Processing Steps

1. Determine device classification as B-class IVD.
2. Prepare documentation: technical files, performance data, risk management documents, labeling.
3. Register on the MDA portal and create an account.
4. Complete the application form online.
5. Upload required documents and ensure compliance with formatting requirements.
6. Submit the application and pay the registration fees.
7. MDA review process: initial review, technical evaluation, and respond to additional information requests.
8. Manufacturing site inspection (if required).
9. Receive approval and registration certificate.
10. Implement post-market surveillance and maintain compliance.

By following these steps diligently, manufacturers can successfully navigate the registration process for B-class IVD medical devices with Malaysia's MDA.

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