The required document content for an NMPA certification application in China typically includes the following:
Application Form: Completed NMPA application form with basic information about the device and manufacturer.
Product Description: Detailed description of the medical device, including specifications, intended use, and indications.
Quality Management System Documentation: Evidence of compliance with ISO 13485 or equivalent, including quality manual and procedures.
Clinical Evaluation Report: Summary of clinical data demonstrating the device’s safety and effectiveness.
Risk Management Report: Assessment of potential risks associated with the device and mitigation strategies.
Testing Reports: Results from relevant safety and performance testing, including biocompatibility, electrical safety, and electromagnetic compatibility.
Labeling and Instructions for Use: Samples of labels, packaging, and user manuals.
Manufacturing Process Description: Information about the manufacturing process, facilities, and quality control measures.
Post-Market Surveillance Plan: Outline of how the manufacturer will monitor the device's safety and effectiveness post-launch.
Authorized Representative Documents: If applicable, documentation appointing a local authorized representative in China.
These documents must be prepared in Chinese and meet NMPA formatting requirements. Would you like to delve into any specific document in detail?
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