When seeking NMPA certification for medical devices in China, manufacturers must adhere to specific specifications and conditions laid out by the National Medical Products Administration (NMPA). Here’s a detailed overview of what to consider:

1. Application Dossier

• General Information: Company profile, device name, intended use, and classification.
• Device Description: Detailed specifications of the medical device, including design, components, materials, and usability.
• Manufacturing Information: Details about manufacturing processes, quality controls, and the facilities involved.
• Risk Assessment: Identification of potential risks associated with the device and measures taken to mitigate these risks.

2. Classification and Classification Verification

• Devices are classified into Class I, II, or III. The correct classification must be established based on the intended use and technological characteristics.
• Class II and III devices typically require a classification verification process, which may include additional documentation.

3. Clinical Evaluation

• For Class II and III devices, clinical evaluation is usually required to demonstrate safety and effectiveness.
• Clinical Trials: If trials are necessary, they must comply with Chinese regulations and potentially include local clinical data.
• Ethics Approval: Before starting trials, ethical review and approval from local ethics committees are required.

4. Compliance with Standards

• Adherence to ISO 13485 for quality management systems is mandatory for all medical device manufacturers.
• It may also be necessary to demonstrate compliance with other relevant standards such as ISO 14971 (risk management) and IEC 60601 (electrical safety), depending on the device type.

5. Quality System Documentation

• Organizations must provide documentation that showcases their quality management systems, including procedures for managing production, supplier controls, design controls, and handling post-market surveillance.

6. Post-Market Surveillance Plan

• Manufacturers must outline their post-market surveillance processes, detailing how they will monitor device performance, report adverse events, and manage product recalls if necessary.

7. Labeling and Instructions for Use (IFU)

• All medical devices must include labeling that is compliant with NMPA requirements, providing clear instructions for use, safety warnings, and information about the manufacturer.
• Material should be in Chinese and be comprehensible to end-users.

8. Registration Fee and Timelines

• A registration fee is required, and the timeline for approval can vary:
  • Class I: Generally quicker, often approved in a few months.
  • Class II and III: Typically take longer due to more extensive review requirements and may take several months to over a year.

9. Local Agent Requirement

• Foreign manufacturers must appoint a local agent in China who is authorized to handle registration and communication with regulatory authorities.

10. Changes and Modifications

• Manufacturers need to report any changes to the device or manufacturing process that could affect safety, effectiveness, or performance. The NMPA may require new evaluations for significant changes.

Key Considerations

• Documentation Accuracy: Ensure all submitted documents are accurate and complete to avoid delays.
• Innovation and Adaptation: Stay aware of any updates to regulations or practices to remain compliant.

By following these specifications and conditions, manufacturers can navigate the NMPA certification process more effectively. If you need assistance regarding specific criteria or further insights on a particular aspect, let me know!

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