To apply for the registration of Class B medical devices in Malaysia, you must meet several key conditions and requirements set by the Medical Device Authority (MDA). Here’s an overview of these conditions:

1. Classification Confirmation

• Verify Device Classification: Ensure that your device is classified as Class B according to MDA’s risk-based classification system. Class B devices are those that present a moderate risk to patients and users.

2. Local Authorized Representative (LAR)

• For Foreign Manufacturers: If you are not based in Malaysia, appoint a local authorized representative (LAR) who will act as your liaison with the MDA and handle regulatory matters.

3. Technical Documentation

• Comprehensive Details: Provide detailed information about the device, including:
  • Device Description: Specifications, design, and intended use.
  • Clinical Evidence: Data demonstrating the safety and effectiveness of the device, such as clinical trial results or performance data.
  • Labeling and Packaging: Labels, packaging details, and instructions for use that meet MDA requirements.
  • Risk Management: Documentation of risk assessment and management strategies, including risk analysis and mitigation measures.
  • Quality Management System (QMS): Proof of compliance with relevant QMS standards like ISO 13485, if applicable.

4. Compliance with Standards

• International and Local Standards: Ensure that your device complies with relevant international standards and Malaysian regulations.

5. Application Form and Fee

• Complete Application Form: Accurately complete the registration application form for Class B devices through the MeDC@St system.
• Pay Registration Fee: Pay the applicable registration fee as specified by MDA.

6. Documentation Requirements

• Accuracy and Completeness: Ensure that all documentation is complete, accurate, and up-to-date. Incomplete or inaccurate information can lead to delays or rejections.

7. Post-Market Surveillance

• Compliance: Be prepared to comply with post-market surveillance requirements, including reporting any adverse events or device-related issues to MDA.

8. Ongoing Compliance

• Renewals and Updates: Ensure that you meet ongoing compliance requirements, including periodic updates or renewals as stipulated by MDA.

Additional Considerations

• Language: Provide all documents in English or Bahasa Malaysia, as required by MDA.
• Regulatory Updates: Stay informed about any changes to MDA regulations or guidelines that may affect your application.

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