For NMPA certification application in China, the required document content typically includes:
Application Form: Completed NMPA application form with basic information about the manufacturer and the medical device.
Device Description: Detailed description of the device, including its intended use, classification, specifications, and technical characteristics.
Quality Management System Documentation: Evidence of compliance with ISO 13485 or relevant quality management standards, including quality manual and procedures.
Risk Management Report: A report outlining the risk management process according to ISO 14971, detailing identified risks and mitigation strategies.
Testing and Evaluation Data:
- Preclinical Testing Reports: Results from safety and performance testing, including biocompatibility, electrical safety, etc.
- Clinical Evaluation Reports: Data supporting the safety and efficacy of the device, including clinical trial results if applicable.
Manufacturing Information: Details about the manufacturing process, including facility information and any subcontractors involved.
Labeling and Instructions for Use: Samples of labeling, packaging, and user instructions that comply with NMPA regulations.
Technical File: A comprehensive file that consolidates all the above documents and supporting materials.
Declaration of Conformity: A document declaring compliance with applicable regulations and standards.
Other Supporting Documents: Any additional documents required by the NMPA, such as distributor agreements or relevant certifications.
Ensuring all documentation is complete, accurate, and well-organized is crucial for a successful application.