To apply for Class C medical device registration with the Malaysian Medical Device Authority (MDA), several key conditions must be met to ensure the device's safety, efficacy, and quality. Here are the main conditions required:

1. Classification as a Class C Device

• Confirm Device Classification: Verify that the device falls under Class C, which typically includes moderate- to high-risk devices such as surgical instruments, diagnostic imaging equipment, and some implantable devices. Use the MDA classification guidelines if needed to confirm.

2. Quality Management System (QMS) Compliance

• ISO 13485 Certification: The device manufacturer must have a quality management system certified to ISO 13485 or an equivalent standard. This demonstrates that the device is produced under stringent quality controls, ensuring consistency and compliance with regulatory standards.
• Quality Manual and SOPs: Submit a Quality Manual that outlines manufacturing, testing, and quality assurance procedures.

3. Valid Clinical Evidence

• Clinical Evaluation Report (CER): Provide clinical evidence supporting the device’s safety and effectiveness, which could include clinical studies, literature reviews, or post-market surveillance data from other markets.
• Summary of Safety and Performance: Include a summary of the device’s safety and performance outcomes, demonstrating that it meets the intended use claims.

4. Risk Management Documentation

• Risk Analysis and Management: Conduct a risk analysis following ISO 14971 standards and submit a report detailing identified risks, mitigations, and any residual risks. This ensures that potential hazards have been identified and addressed, showing a commitment to patient safety.

5. Device Labeling and Instructions for Use (IFU)

• Compliant Labeling: The device must have clear, compliant labeling that includes the device name, intended use, manufacturer details, warnings, and other essential information.
• Instructions for Use (IFU): Provide IFU documents that clearly explain how to safely and effectively use the device. The IFU should include any necessary warnings, maintenance steps, and operating instructions.

6. Appointment of Local Authorized Representative (for Foreign Manufacturers)

• Local Representation: If the manufacturer is based outside Malaysia, a local authorized representative registered with MDA must handle the regulatory application and communications on behalf of the manufacturer.

7. Declaration of Conformity (DoC)

• DoC Requirements: Provide a signed Declaration of Conformity (DoC) from an authorized individual, affirming that the device complies with all applicable MDA standards and safety requirements.

8. MeDC@St Account Registration

• Account Registration on MeDC@St Portal: The applicant (either the manufacturer or authorized representative) must register for an account on MDA’s MeDC@St portal (https://medcast.mda.gov.my), which is used for submitting and tracking the application.

9. Adherence to Regulatory Standards

• Compliance with MDA Guidelines: Ensure that all documentation, testing, and processes adhere to MDA’s regulatory standards. Following MDA’s published guidelines and specific documentation formats can help avoid delays in the review process.

10. Post-Market Surveillance Plan

• Surveillance Preparedness: Prepare a post-market surveillance plan that includes tracking adverse events, reporting incidents, and monitoring device performance. This plan should outline how the device’s safety and efficacy will be continually assessed after market entry.

Meeting these conditions will increase the likelihood of successful Class C medical device registration with the Malaysian MDA. Compliance with quality standards, risk management practices, and submission requirements ensures the application aligns with MDA's regulatory standards. Let me know if you'd like further details on any of these conditions!