To apply for Class C medical device registration in Malaysia, several key conditions and requirements need to be met to ensure compliance with the Medical Device Authority (MDA) regulations. Here’s a summary of the conditions that must be fulfilled:

Conditions for Applying for Class C Medical Device Registration

1. Device Classification

   • Confirm Classification: Ensure that the device is correctly classified as Class C according to the Medical Device Regulations 2012. Class C devices are considered medium to high risk, which dictates the level of scrutiny and requirements for registration.

2. Authorized Representative (AR)

   • For Non-Malaysian Manufacturers: Appoint a local Authorized Representative (AR) in Malaysia who is registered with the MDA. The AR must be responsible for managing the registration process and acting as the point of contact with the MDA.

3. Common Submission Dossier Template (CSDT)

   • Documentation: Prepare a comprehensive Common Submission Dossier (CSDT) that includes:
     • Device Description: Detailed specifications, intended use, and functionality.
     • Risk Management: Evidence of risk analysis and management in line with ISO 14971.
     • Clinical Evidence: Clinical data demonstrating the device’s safety and effectiveness.
     • Manufacturing Information: Details about the manufacturing process and facilities.
     • Labeling and Instructions for Use: Clear and compliant labeling, packaging, and user instructions.
     • Compliance with Essential Principles: Demonstration of how the device meets essential safety and performance principles.

4. Conformity Assessment

   • Certification: Obtain a conformity assessment report from a recognized Conformity Assessment Body (CAB). This includes:
     • Full Quality Assurance (FQA) Audit: Certification of the quality management system.
     • Type Examination: Evaluation of the device itself to ensure it meets regulatory standards.

5. Quality Management System (QMS) Certification

   • ISO 13485: Provide valid certification for a Quality Management System (QMS) such as ISO 13485, which demonstrates compliance with international standards for medical device manufacturing.

6. Regulatory Fees

   • Payment: Be prepared to pay the applicable registration fees for Class C devices. Fees vary based on the device and other factors, so check the latest fee structure on the MDA website.

7. Compliance with MDA Regulations

   • Regulatory Requirements: Ensure all documentation and procedures comply with the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012. This includes adherence to safety, performance, and regulatory standards.

8. Pre-Submission Preparation

   • Documentation Accuracy: Ensure that all documents are accurate, complete, and up-to-date. Incomplete or incorrect documentation can delay the approval process.
   • Engage Local Expertise: Consider engaging a regulatory consultant or legal expert familiar with Malaysian regulations to assist with the application process, especially if you are new to the Malaysian market.

Summary of Conditions

• Correct Device Classification: Verify that the device is properly classified as Class C.
• Authorized Representative: Appoint a local AR (if applicable).
• Comprehensive Documentation: Prepare and compile the CSDT, clinical evidence, risk management, manufacturing information, and labeling.
• Conformity Assessment: Obtain certification from a recognized CAB.
• Quality Management System Certification: Provide proof of ISO 13485 or equivalent certification.
• Fee Payment: Ensure payment of the applicable registration fees.
• Regulatory Compliance: Adhere to all MDA regulations and guidelines.
• Documentation Accuracy: Ensure completeness and accuracy of all submitted documents.

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