The license application process for NMPA (National Medical Products Administration) certification in China involves several key steps. Here’s an overview of the main phases to help you navigate the requirements effectively:

1. Preparation of Application Materials

• Determine Device Classification: Identify the correct classification (Class I, II, or III) based on the intended use and risk.
• Compile Required Documentation: Prepare the necessary materials, such as:
  • Device description and specifications.
  • Manufacturing processes and quality management system documentation (e.g., ISO 13485 certification).
  • Clinical evaluation and trial data, if applicable.
  • Risk management documents (ISO 14971).

2. Appointment of a Local Agent

• For foreign manufacturers, appoint a local agent in China. This agent will represent the company in communications with the NMPA and assist with the registration process.

3. Application Submission

• Electronic Submission: Applications are typically submitted electronically through the NMPA's online system.
• Submission of Dossier: Provide the completed application form and all required documentation. This usually includes:
  • A signed application form (form varies based on classification).
  • Quality management system documentation and supporting materials.
  • Product testing reports and clinical data.
  • Labeling and instructions for use in Chinese.

4. Administrative Review

• Once submitted, the NMPA conducts an initial review to ensure the application is complete and the documentation meets the submission requirements. Any deficiencies may result in a request for additional information or resubmission.

5. Technical Review

• The NMPA will perform a detailed technical assessment, which may involve:
  • Evaluation of the safety and effectiveness of the device based on the submitted materials.
  • Review of clinical trial data, if clinical evaluation was required.
  • Risk assessment analysis and compliance with relevant standards.

6. On-Site Inspection (if applicable)

• For Class II and Class III devices, the NMPA may conduct an on-site inspection of manufacturing facilities to ensure compliance with quality management systems and regulatory requirements.

7. Approval Decision

• After completion of the reviews and inspections, the NMPA will make an approval decision:
  • If approved, the manufacturer receives a Medical Device Registration Certificate, allowing the device to be marketed in China.
  • If rejected, the NMPA will provide reasons for rejection, and manufacturers can address the issues and reapply.

8. Issuance of Registration Certificate

• Upon approval, the manufacturer receives the registration certificate along with a registration number, which must be included on the product packaging and promotional materials.

9. Post-Market Obligations

• Once the device is on the market, manufacturers are required to adhere to post-market surveillance requirements, including:
  • Monitoring product safety and effectiveness.
  • Reporting adverse events to the NMPA.
  • Maintaining records of customer complaints and conducting periodic reports.

Key Considerations

• Preparation Time: The entire process can take several months to over a year, depending on the device class and complexity.
• Regulatory Changes: Keep abreast of changing regulations and practices to ensure ongoing compliance.
• Engagement with NMPA: Establish regular communication with the NMPA, especially if clarification or guidance is needed during the application process.

This overview encapsulates the key steps involved in the NMPA certification process. If you require more specific details about any particular step or have other questions, feel free to ask!

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