The registration procedure for Class II medical devices with the National Medical Products Administration (NMPA) in China involves several steps. Class II devices are considered moderate-risk and require a more comprehensive registration process compared to Class I devices. Here’s a detailed overview of the procedure:

1. Determine Device Classification

• Confirm that the device qualifies as a Class II medical device according to the NMPA classification guidelines. This classification will dictate the registration requirements.

2. Preliminary Preparation

• Quality Management System (QMS): Ensure compliance with ISO 13485 or equivalent standards. A robust QMS is crucial for demonstrating the device's safety and efficacy.
• Documentation Compilation: Prepare the necessary documentation, which typically includes:
  • Application Form: Complete and accurate application form for registration.
  • Device Description: Detailed description of the device, including specifications, intended use, and any relevant standards.
  • Safety and Efficacy Data: Data demonstrating the safety and efficacy of the device, which may include pre-clinical testing results.
  • Clinical Evaluation Report: A report summarizing clinical data supporting the device’s safety and effectiveness.

3. Local Agent Requirement

• Appointment of Local Agent: If the manufacturer is a foreign entity, appoint a local agent in China. This agent will facilitate communication with the NMPA and assist in navigating the registration process.

4. Submission of Application

• Online Submission: Submit the application through the NMPA's online platform. Ensure all documents are translated into Chinese and comply with the NMPA’s formatting requirements.
• Filing Fees: Pay applicable registration fees, which vary depending on the device type and complexity.

5. Review Process

• Technical Review: The NMPA conducts a detailed review of the submitted documents, focusing on safety, efficacy, and compliance with regulatory standards.
• Supplementary Information: Be prepared to provide additional information or clarification if requested by the NMPA during the review process.

6. On-Site Inspection

• Facility Inspection: The NMPA may conduct an on-site inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and the QMS.
• Document Review: The inspection will include a review of relevant documentation related to manufacturing processes and quality control.

7. Issuance of Registration Certificate

• Approval Notification: If the application is approved, the NMPA issues a Class II medical device registration certificate.
• Validity Period: The registration is typically valid for five years, after which renewal is required.

8. Post-Market Surveillance

• Compliance Requirements: After registration, manufacturers must adhere to post-market surveillance obligations, including monitoring the device’s performance and reporting adverse events.
• Adverse Event Reporting: Establish processes for reporting any safety concerns or adverse events related to the device to the NMPA.

9. Renewal and Changes

• Registration Renewal: Initiate the renewal process before the registration certificate expires. This often involves submitting updated documentation and demonstrating continued compliance.
• Changes to Device: Report any significant changes to the device or its manufacturing process to the NMPA, which may necessitate additional review or re-registration.

Conclusion

Navigating the registration procedure for Class II medical devices with the NMPA in China requires careful preparation and adherence to regulatory standards. Manufacturers are encouraged to engage local regulatory consultants to facilitate the process and ensure compliance with all requirements, thereby enhancing the likelihood of a successful registration outcome.

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