To register a medical device with NMPA (National Medical Products Administration) in China, you need to meet several essential requirements. Here's a breakdown:

1. Device Classification

• Class I: Low-risk devices with minimal regulatory control.
• Class II: Moderate-risk devices requiring more stringent controls.
• Class III: High-risk devices subject to the highest level of scrutiny.

2. Documentation

• Application Form: Complete and submit the NMPA registration application form.
• Device Description: Detailed description of the device, including its intended use and technical specifications.
• Clinical Data: Clinical trial data demonstrating safety and effectiveness, especially for Class II and III devices.
• Manufacturing Information: Details about the manufacturing process, quality control, and facility certifications (e.g., GMP certification).
• Labeling and Instructions: Product labeling, packaging, and instructions for use in Chinese.

3. Technical Requirements

• Technical File: Includes device specifications, design and manufacturing processes, and test reports.
• Quality Management System (QMS): Compliance with Good Manufacturing Practice (GMP) standards is mandatory.

4. Clinical Trials

• For Class II and III Devices: Clinical trials in China may be required. The trials must follow local regulations and be approved by NMPA before starting.

5. Local Representation

• Foreign Manufacturers: Must appoint a local representative or agent in China to handle regulatory affairs and post-market responsibilities.

6. Translation

• Documentation: All documents must be translated into Chinese, or accompanied by a certified translation.

7. Fees

• Application Fees: Pay applicable registration and inspection fees, which vary depending on the device class and complexity.

8. Post-Market Surveillance

• Monitoring: Comply with post-market surveillance requirements, including reporting adverse events and participating in inspections.

9. Regulatory Updates

• Stay Informed: Regularly check for updates to NMPA regulations to ensure ongoing compliance.

Useful Resource

For detailed guidance and official documentation, visit the NMPA’s website: NMPA Official Website. Consulting with regulatory experts or local agents can also provide valuable assistance throughout the registration process.

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