Periodic updates and renewals for Class I medical device registration with China's National Medical Products Administration (NMPA) are essential to maintain compliance and market authorization. Here are the standards and procedures typically involved:

Standards and Guidelines:

1. Regulatory Updates:

   • Stay informed about updates and changes in Chinese regulations pertaining to medical devices, including Class I devices. Monitor announcements and notifications from the NMPA to ensure compliance with new standards or requirements.

2. ISO Standards:

   • Continue to adhere to ISO 13485 or an equivalent quality management system standard for maintaining the quality and regulatory compliance of your manufacturing processes.

3. National Standards:

   • Comply with relevant Chinese national standards (GB standards) applicable to your device category, ensuring ongoing alignment with safety and performance requirements.

Procedures for Periodic Updates:

1. Renewal of Registration:

   • Class I medical device registrations typically require periodic renewal with the NMPA. Prepare and submit renewal applications according to the specified timelines and requirements.

2. Documentation Review:

   • Conduct regular reviews of technical documentation, including device specifications, manufacturing processes, risk assessments, and testing reports. Update these documents as necessary to reflect any changes or improvements.

3. Quality Management System (QMS) Audits:

   • Maintain a robust QMS and undergo regular audits to ensure continued compliance with ISO 13485 or equivalent standards. Address any findings or non-conformities identified during audits promptly.

4. Post-Market Surveillance (PMS):

   • Continue to monitor post-market performance and safety of your device through surveillance activities. Report any adverse events or safety concerns to the NMPA as required.

5. Labeling and IFU Updates:

   • Review and update labeling and instructions for use (IFU) to reflect any changes in device specifications or regulatory requirements. Ensure all labeling remains accurate and compliant with Chinese regulations.

6. Communication with NMPA:

   • Maintain open communication with the NMPA and promptly respond to any inquiries or requests for additional information related to your device registration or renewal.

7. Local Agent Responsibilities:

   • Collaborate closely with your local agent in China to facilitate renewal processes, compliance updates, and regulatory interactions with the NMPA.

Timelines and Submission:

• Renewal Timelines:

  • Follow the specified timelines for renewal applications as communicated by the NMPA. Ensure submissions are timely to avoid lapses in market authorization.

• Submission Protocols:

  • Adhere to the NMPA’s submission protocols and guidelines for document formatting, electronic submissions, and any specific requirements related to renewal applications.

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