To apply for Class C medical device registration with the Malaysian Medical Device Authority (MDA), manufacturers must meet specific requirements, ensuring the device's safety, quality, and compliance with Malaysian regulations. Here’s a breakdown of the key requirements:

1. Device Classification Confirmation

• Confirm that your device is classified as Class C under MDA guidelines, which includes moderate to high-risk devices (e.g., diagnostic imaging devices, implantable devices).

2. Technical Documentation

• Device Description: Include a detailed description of the device, including its intended purpose, functionality, and target user.
• Design and Manufacturing Information: Provide details about the device’s design, including diagrams, manufacturing processes, and material specifications.
• Risk Management Report: Document the risk assessment according to ISO 14971, outlining potential risks, mitigations, and risk acceptability.
• Product Verification and Validation: Provide testing and validation results, which may include performance testing, biocompatibility tests, and sterility validation.

3. Clinical Evidence

• Clinical Evaluation Report (CER): Submit clinical evidence to support the safety and effectiveness of the device, which can include clinical studies, literature reviews, and post-market data.
• Summary of Safety and Performance: This should be a concise overview of the device’s safety profile, clinical benefits, and overall performance in clinical use.

4. Quality Management System (QMS) Compliance

• Evidence of compliance with ISO 13485 or equivalent QMS certification is mandatory. This demonstrates that the device is produced in a controlled, quality-assured environment.
• Provide QMS documentation that includes information on quality policies, procedures, and manufacturing control measures.

5. Labeling and Instructions for Use

• Ensure the device’s labeling includes:
  • Device name and description.
  • Intended purpose.
  • Manufacturer’s details and address.
  • Any precautions, warnings, or contraindications.
• Provide Instructions for Use (IFU) that are clear, detailed, and compliant with MDA standards, enabling users to use the device safely and effectively.

6. Appoint a Local Authorized Representative (if applicable)

• For foreign manufacturers, appoint a local authorized representative in Malaysia. This representative will be responsible for managing communications with MDA and ensuring regulatory compliance in Malaysia.

7. Application Form (MD-1)

• Complete the Medical Device Registration Application Form (MD-1), which is the standard form for medical device registration with the MDA.

8. Payment of Registration Fees

• Pay the applicable registration fees, which vary by device classification and are subject to periodic updates. Check the MDA website for the latest fee structure.

9. Post-Market Surveillance Requirements

• Prepare a plan for post-market surveillance, including adverse event monitoring and reporting protocols as per MDA guidelines.
• Document a plan for periodic safety updates and ongoing monitoring of device performance.

10. Declaration of Conformity

• Submit a Declaration of Conformity (DoC) signed by an authorized person, affirming that the device meets all applicable regulatory requirements.

Additional Tips

• Check for Updated Guidelines: MDA periodically updates its guidelines, so make sure to verify that all submitted documents align with the latest regulations.
• Consider Consulting a Regulatory Expert: Navigating MDA’s requirements can be complex, and consulting a local expert can help ensure compliance.

Useful Resources

• MDA Website: MDA – Access application forms, guidelines, and fee information.
• Medical Device Act 737: Familiarize yourself with the regulatory requirements under this act.

Each of these requirements ensures that Class C devices meet Malaysian standards, protecting patient and user safety. If you need more specific guidance on any document or step, feel free to ask!