To register a B-class in vitro diagnostic (IVD) medical device with Malaysia's Medical Device Authority (MDA), you’ll need to follow specific procedures, prepare required materials, and be mindful of key regulatory points. Here’s a breakdown:

1. Procedures for Registration

• Device Classification Confirmation: Ensure your device falls under Class B, which is low-to-moderate risk according to MDA’s classification rules.
• Establish a MeDISS Account: Register on MDA’s Medical Device Information and Safety System (MeDISS) portal, which is mandatory for online application submission.
• Submit Application on MeDISS: Fill out the application form for Class B IVD registration and upload all necessary supporting documents.
• Fee Payment: Complete the payment for registration fees through the MeDISS portal as prompted.
• MDA Review: MDA will review your submission. They may request additional information or clarifications if needed.
• Approval and Certification: Upon successful evaluation, MDA will issue a registration certificate for your device.
• Post-Market Surveillance: Maintain compliance with MDA’s post-market requirements, such as adverse event reporting and surveillance activities.

2. Required Materials

• Device Description: Detailed information on the IVD device, including the intended use, components, design, and operating principles.
• Risk Management File: Documentation of a risk assessment that identifies potential hazards, mitigation measures, and residual risks, often in line with ISO 14971 standards.
• Performance and Safety Data: Evidence of the device’s performance, accuracy, and reliability. This includes clinical and non-clinical data or studies that validate safety and efficacy.
• Labeling and Instructions for Use (IFU): Include labeling information such as intended use, instructions, warnings, precautions, and contraindications, in both English and any relevant local languages.
• Quality Management System (QMS) Certification: An ISO 13485 certification for the manufacturing facility is generally required to demonstrate that production follows quality and safety standards.
• Declaration of Conformity: A signed statement by the manufacturer affirming that the device complies with Malaysian regulatory requirements.
• Manufacturer Information: Documentation on the manufacturer, including company background, manufacturing site details, and any outsourced production or packaging processes.

3. Points to Note

• Local Authorized Representative: For foreign manufacturers, it’s mandatory to appoint a local authorized representative who will act on your behalf and communicate with MDA. They are responsible for post-market surveillance, device traceability, and adverse event reporting in Malaysia.
• Conformity Assessment: Although Class B devices are generally moderate-risk, MDA may still require certain IVD devices to undergo additional conformity assessments through a notified body.
• Post-Market Compliance: MDA requires ongoing post-market surveillance to monitor device safety and effectiveness after approval. This includes mandatory adverse event reporting, as well as implementing corrective actions if any device issues are identified.
• Registration Validity and Renewal: Registration certificates for Class B devices are typically valid for five years, after which renewal is required to maintain market authorization.
• Adherence to Malaysian Standards (MS): Check if there are Malaysian Standards applicable to your device type. Compliance with MS is strongly encouraged by MDA and may streamline the registration process.
• Continuous Updates: Regulations may change, so it’s beneficial to regularly consult MDA’s latest guidelines and updates, especially for updates to IVD registration and technical requirements.

By closely following these procedures, preparing comprehensive documentation, and adhering to MDA's specific requirements, you can navigate the registration process effectively and maintain compliance in the Malaysian market.

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