Yes, China's NMPA certification requires medical device companies to provide detailed background information as part of the application process. This includes:

1. Company Information

• Business License: A copy of the company's business license and registration details.
• Quality Management System: Evidence of compliance with ISO 13485 or other relevant quality management standards.

2. Manufacturing Details

• Manufacturing Facility Information: Details about the manufacturing site, including its address and facilities.
• Production Processes: Descriptions of the manufacturing processes and quality control measures in place.

3. Device Information

• Product Specifications: Detailed technical specifications and intended use of the medical device.
• Design and Development History: Information about the design history, including risk management and testing results.

4. Clinical Data

• Clinical Evaluation Reports: If applicable, clinical data demonstrating the safety and efficacy of the device, including results from clinical trials or studies.

5. Post-Market Surveillance Plans

• Surveillance Strategies: Plans for monitoring the device’s performance post-market, ensuring ongoing safety and effectiveness.

Providing this comprehensive background information is essential for demonstrating compliance with NMPA regulations and facilitating the certification process.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn