The safety review standards and technical requirements for medical devices certified by China’s NMPA include:

**1. Regulatory Standards:

• National Standards: Compliance with Chinese national standards (GB standards) specific to the device type.
• International Standards: Alignment with international standards (e.g., ISO, IEC) if applicable.

**2. Technical Documentation:

• Device Description: Detailed technical specifications, design, and intended use.
• Risk Management: Risk assessment in accordance with ISO 14971, including risk analysis, evaluation, and control measures.

**3. Safety and Performance Testing:

• Clinical Data: Evidence of safety and efficacy from clinical trials or studies.
• Performance Testing: Results from performance, safety, and reliability tests, including biocompatibility and, if relevant, electrical safety.

**4. Quality Management System (QMS):

• QMS Documentation: Evidence of compliance with ISO 13485 or equivalent, covering quality control, manufacturing processes, and post-market surveillance.

**5. Labeling and Instructions:

• Instructions for Use (IFU): Clear and comprehensive user manuals, including safety information and operating instructions.
• Labeling: Compliance with Chinese labeling requirements, including product name, manufacturer information, and usage instructions in Chinese.

**6. Manufacturing and Control:

• Manufacturing Processes: Documentation of manufacturing procedures, quality control measures, and facility standards.
• Traceability: Systems for tracking and recalling devices if necessary.

**7. Post-Market Surveillance:

• Monitoring: Plans for ongoing safety monitoring, reporting adverse events, and implementing corrective actions.

These standards ensure that medical devices meet safety, efficacy, and quality requirements before they are approved for the Chinese market.

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