Handling the registration of Class B medical devices in Malaysia involves a structured process governed by the Medical Device Authority (MDA), and it must be done through the MeDC@St system. Here's a step-by-step guide to managing the registration process:

1. Understand the Regulatory Requirements

Before starting the process, ensure that you are familiar with the relevant Malaysian regulations:

• Medical Device Act 2012 (Act 737)
• Medical Device Regulations 2012
• Medical Device (Exemption) Order 2016
• ISO Standards (such as ISO 13485 for quality management and ISO 14971 for risk management).

2. Determine Device Classification

• Confirm that your device is classified as Class B (low-to-moderate risk). If you’re uncertain about the classification, you can refer to the MDA's Guideline on Medical Device Classification or seek professional regulatory consultation.

3. Appoint a Local Authorized Representative (LAR)

• If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) in Malaysia. The LAR will act on your behalf in the registration process and must be based in Malaysia.
• The LAR must have a valid Good Distribution Practice for Medical Devices (GDPMD) certification.

4. Prepare the Required Documents

Gather all the necessary documentation before submitting the registration application. The key documents required include:

• Technical Documentation: Including device description, intended use, design, manufacturing process, and technical specifications.
• Risk Management Report: A risk assessment aligned with ISO 14971 showing that risks have been minimized.
• Clinical Evaluation Report (CER): Clinical data or evidence demonstrating the safety and performance of the device. For Class B devices, the level of clinical evidence required may vary depending on the device's intended use and prior approvals.
• Labeling and Instructions for Use (IFU): Ensure that the labeling complies with MDA guidelines, with all necessary symbols, instructions, and warnings.
• Quality Management System (QMS) Certification: A certificate proving compliance with ISO 13485, or equivalent quality standards, for the manufacturing facility.
• Declaration of Conformity (DoC): A signed document stating that the device meets all relevant safety and regulatory standards.
• Post-Market Surveillance (PMS) Plan: A plan detailing how you will monitor the safety and performance of the device once it is in the market.

5. Register on the MeDC@St System

• Create an Account: Visit the MeDC@St (Medical Device Centralized Online System) portal (https://medcast.mda.gov.my/) and create an account for the manufacturer or LAR.
• Complete Your Profile: Fill in all required fields for your company or LAR profile, including contact details and other relevant information.

6. Submit the Application

• Enter Device Details: Log in to the MeDC@St system and begin a new registration application. Enter all required details about the Class B medical device, including its classification, group, and specific characteristics.
• Upload Required Documents: Upload the prepared technical documentation, risk management reports, clinical data, and any other required files through the system.
• Pay the Registration Fees: Calculate and pay the registration fees. The amount depends on the class of the device, and payment is processed through the MeDC@St system.

7. MDA Review Process

• Initial Review: Once the application is submitted, the MDA will perform an initial check to ensure that all required documents and information are present.
• Detailed Review: The MDA will then review the technical documentation, clinical evidence, and risk management information to ensure that the device complies with safety standards.
• Respond to Queries: If the MDA requests additional information or clarification, respond promptly through the MeDC@St system to avoid delays. Keep an eye on the system for any notifications or requests for further information.

8. Approval and Issuance of Certificate

• If the application is successful and the device complies with all regulatory requirements, the MDA will issue a Certificate of Registration.
• The certificate will allow the device to be legally marketed and distributed in Malaysia for a period of 5 years.

9. Post-Approval Obligations

• Post-Market Surveillance (PMS): After approval, you are required to maintain a PMS system to monitor the device's safety and performance in the market. Report any adverse events, safety issues, or recalls to the MDA through the appropriate channels.
• Vigilance Reporting: Set up a vigilance reporting system to monitor adverse events and respond to safety concerns.
• Re-registration: Before the certificate expires (typically after 5 years), you will need to re-register the device by submitting updated documentation and ensuring continued compliance with regulations.

10. Post-Market Activities

• Maintain Compliance: Ensure that the device continues to comply with the standards and requirements outlined by the MDA throughout its lifecycle in the market.
• Renewal of Registration: Devices must be re-registered every 5 years to remain on the market.

Considerations for a Smooth Registration Process

• Document Accuracy: Ensure that all documents are thorough, accurate, and comply with MDA’s guidelines to avoid delays.
• Timely Responses: Be prompt in responding to any MDA requests for additional information or clarifications to prevent delays in the review process.
• Consultation and Expertise: If unsure about any part of the process, consult with a regulatory expert or local consultant who is familiar with the MDA’s requirements.