The approval requirements for NMPA registration of Class III medical devices in China are stringent due to the higher risk associated with these devices. Here’s a detailed breakdown of the requirements and process:

1. Pre-Application Preparation

**a. Determine Classification:

• Confirm that the device is classified as Class III. Class III devices are high-risk and include items such as pacemakers, large implants, and advanced diagnostic equipment.

**b. Gather Technical Documentation:

• Prepare comprehensive technical documentation including device specifications, design and manufacturing processes, intended use, and risk management.

**c. Clinical Data:

• Collect clinical data to demonstrate the safety and efficacy of the device. This often involves conducting clinical trials or using data from similar devices if acceptable by the NMPA.

**d. Quality Management System (QMS):

• Ensure compliance with a recognized QMS standard such as ISO 13485. Include evidence of certification in your application.

**e. Foreign Certifications:

• Provide copies of relevant certifications from foreign regulatory authorities (e.g., FDA, CE) if available.

2. Appoint a Chinese Agent

**a. Select an Agent:

• Appoint a Chinese legal agent or representative who will handle regulatory affairs and liaise with the NMPA.

**b. Submit Agent Information:

• Include details of the appointed agent in your application.

3. Prepare and Submit the Application

**a. Compile Application Materials:

• Prepare the application package, including:
  • Technical documentation
  • Clinical data
  • QMS certification
  • Foreign certifications
  • Product labeling and instructions in Chinese

**b. Complete Application Form:

• Accurately fill out the NMPA application form, available from the NMPA or through your agent.

**c. Submit Application:

• Submit the completed application and all supporting documents to the NMPA through their online submission system or in person.

4. Application Review

**a. Initial Review:

• The NMPA will perform an initial review to ensure that all required documents are complete and properly filled out.

**b. Technical Review:

• A detailed review of the device’s safety, effectiveness, and compliance with Chinese standards will be conducted. This may include reviewing clinical trial data and technical documentation.

**c. Additional Information:

• Be prepared to provide additional information or clarification if requested by the NMPA during the review process.

5. Device Testing and Inspection

**a. Testing Requirements:

• Some Class III devices may require additional testing by designated testing institutions to ensure compliance with Chinese standards.

**b. Facility Inspection:

• The NMPA may conduct an on-site inspection of the manufacturing facility to verify compliance with quality management and manufacturing practices.

6. Approval Process

**a. Approval Notification:

• If the device meets all requirements, you will receive an approval notification from the NMPA.

**b. Registration Certificate:

• The NMPA will issue a registration certificate, allowing you to market the device in China.

7. Post-Market Responsibilities

**a. Adverse Event Reporting:

• Implement procedures for monitoring and reporting any adverse events or issues associated with the device.

**b. Regulatory Updates:

• Stay informed about regulatory changes and ensure ongoing compliance with NMPA requirements.

**c. Renewals and Changes:

• Manage device renewals and report any significant changes to the device or manufacturing process as required by the NMPA.

Additional Notes

• Clinical Trials: For many Class III devices, clinical trials conducted in China or internationally are necessary to provide evidence of safety and efficacy. Ensure that trials comply with Chinese regulations.
• Documentation Language: All documentation submitted to the NMPA must be in Chinese or accompanied by certified translations.

By adhering to these requirements and processes, manufacturers can effectively navigate the approval process for Class III medical devices and gain access to the Chinese market.

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