The process for registering a B-class in vitro diagnostic (IVD) medical device with Malaysia's Medical Device Authority (MDA) involves several key steps. Below is a detailed overview of the registration process:

Step-by-Step Process for B-Class IVD Registration

1. Pre-Submission Preparations

• Device Classification: Confirm that the device is classified as a B-class IVD based on MDA classification criteria.
• Quality Management System (QMS): Ensure compliance with ISO 13485 standards and have a documented QMS in place.
• Technical Documentation: Prepare the required technical documentation, including:
  • Device description and intended use
  • Performance evaluation data (clinical and non-clinical)
  • Risk management documentation (ISO 14971)
  • Labeling and instructions for use (IFU)

2. Application Submission

• Register on the MDA Portal: Create an account on the MDA's online registration portal (e-Submission system).
• Complete the Application Form: Fill out the application form for B-class IVD registration on the portal.
• Upload Required Documents: Upload all required documents and technical files. Ensure that they are in the correct format and contain all necessary information.
• Pay Registration Fees: Submit the required registration fees through the online payment system as specified by MDA.

3. Review and Evaluation

• Initial Review by MDA: MDA will conduct an initial review of the application to ensure all necessary information and documents are provided.
• Technical Evaluation: The application will undergo a technical evaluation to assess the safety, performance, and compliance of the device with Malaysian regulations.
• Request for Additional Information: If needed, MDA may request additional information or clarification. Be prepared to respond promptly to such requests.

4. Inspection (if applicable)

• Manufacturing Site Inspection: For certain devices or situations, MDA may require an inspection of the manufacturing facility to verify compliance with quality standards.
• Preparation for Inspection: Ensure that the manufacturing site is prepared for inspection and that all relevant documentation is accessible.

5. Approval and Issuance of Certificate

• Approval Decision: If the evaluation is successful and all requirements are met, MDA will approve the application.
• Issuance of Registration Certificate: Upon approval, MDA will issue a registration certificate for the B-class IVD, allowing the device to be marketed in Malaysia.

6. Post-Market Responsibilities

• Implement Post-Market Surveillance (PMS): Establish a PMS plan to monitor the device's performance and safety in the market. Regularly collect and analyze data on adverse events and user feedback.
• Maintain Quality Management System: Continue to uphold compliance with ISO 13485 and conduct regular internal audits.
• Renew Registration: Monitor the registration validity period and prepare for renewal well in advance (typically every five years).

Summary of Steps for B-Class IVD Registration

1. Pre-Submission Preparations: Confirm classification, establish QMS, and prepare technical documentation.
2. Application Submission: Register on the MDA portal, complete the application form, upload documents, and pay fees.
3. Review and Evaluation: Undergo initial review and technical evaluation, responding to any additional information requests.
4. Inspection (if applicable): Prepare for manufacturing site inspections as required.
5. Approval and Issuance of Certificate: Receive approval and registration certificate from MDA.
6. Post-Market Responsibilities: Implement PMS, maintain QMS, and prepare for registration renewal.

By following these steps carefully and ensuring compliance with all regulations, manufacturers can successfully register their B-class IVD medical devices with Malaysia's MDA.

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