The approval process for NMPA registration of Class I medical devices in China is generally simpler than for Class II and III devices, as Class I devices are considered low-risk. Here’s an overview of the process:

1. Determine Classification

• Confirm that the device qualifies as a Class I medical device according to the NMPA classification guidelines.

2. Prepare Required Documentation

• Although Class I devices do not require a formal approval process, manufacturers must prepare the following documents for record-filing:
  • Application Form: Basic information about the device and manufacturer.
  • Device Description: Technical specifications, intended use, and any relevant standards.
  • Quality Management System Documentation: Evidence of compliance with ISO 13485 or equivalent, demonstrating a robust quality management system.

3. Local Agent Requirement

• Foreign manufacturers must appoint a local agent in China to assist with the registration process and communicate with the NMPA.

4. Filing the Record

• Submit the required documents through the NMPA’s online system. Ensure that all documents are in Chinese and follow the specific formatting guidelines provided by the NMPA.

5. Review Process

• The NMPA conducts a review of the submitted documents. This review focuses on ensuring that the device meets the relevant safety and efficacy standards.
• The review period for Class I devices is typically shorter than that for Class II or III devices, often taking around 20 working days.

6. Issuance of Record-Filing Certificate

• If the submission meets all requirements, the NMPA issues a record-filing certificate. This certificate allows the manufacturer to market the Class I medical device in China.

7. Post-Market Obligations

• Once registered, manufacturers must comply with post-market surveillance requirements, including:
  • Reporting adverse events.
  • Maintaining product quality and safety.
  • Conducting regular updates of product information as necessary.

Additional Considerations

• Labeling and Instructions for Use: Ensure that product labeling and instructions comply with NMPA requirements, including translation into Chinese.
• Product Quality: Manufacturers should establish and maintain a quality management system to ensure ongoing compliance and safety.

Useful Resources

• For detailed information, manufacturers can refer to the official NMPA website, which provides guidance on registration and requirements for medical devices.

Engaging a local regulatory consultant can also help streamline the process and ensure compliance with all local regulations.