For the NMPA (National Medical Products Administration) registration process in China, the following specific information is required:

1. Application Form

• Complete Application: Detailed form including basic information about the device and the manufacturer.

2. Device Description

• Product Specifications: Detailed description of the device’s design, materials, and intended use.
• Technical Parameters: Performance characteristics and operating principles.

3. Manufacturer Information

• Company Details: Name, address, and contact information of the manufacturer.
• Factory Inspection: Information related to the manufacturing facility, including quality control systems and compliance with Good Manufacturing Practices (GMP).

4. Technical Documentation

• Design Documentation: Detailed drawings, schematics, and descriptions of the device’s design.
• Manufacturing Process: Documentation of the manufacturing process, including quality control measures.

5. Clinical Data

• Clinical Evaluation Report: Summary of clinical trials or studies demonstrating the device’s safety and efficacy.
• Study Protocols and Results: Detailed reports from clinical testing, including methodologies and outcomes.

6. Safety and Efficacy

• Risk Management Report: Analysis of potential risks associated with the device and mitigation strategies.
• Performance Testing Results: Data from tests showing that the device meets performance and safety standards.

7. Quality Management System

• ISO 13485 Certification: Proof of compliance with international quality management standards.
• Quality Control Procedures: Details of quality assurance practices and procedures.

8. Labeling and Instructions

• Product Labels: Samples of product labeling with necessary information such as device name, manufacturer details, and usage instructions.
• Instructions for Use (IFU): Comprehensive user manual detailing the safe and effective use of the device.

9. Regulatory Compliance

• Compliance Statements: Evidence that the device complies with Chinese regulations and standards.
• Import and Distribution Licenses: Documentation required for importing and distributing the device in China.

10. Post-Market Surveillance

• Surveillance Plan: Outline of plans for monitoring the device’s performance in the market and addressing potential issues.
• Adverse Event Reporting: Procedures for reporting and managing adverse events related to the device.

11. Additional Documentation

• Environmental Impact Assessment: If applicable, an assessment of the device’s environmental impact.
• Ethical Compliance: Proof that clinical studies adhere to ethical standards.

This comprehensive information helps NMPA evaluate the safety, efficacy, and quality of the medical device to ensure it meets the necessary regulatory requirements for market approval in China.