The NMPA Class I Registration process for medical devices in China is the least complex among the different classes (Class II and III). However, it still requires manufacturers to follow specific steps to ensure compliance with the regulatory requirements set by the National Medical Products Administration (NMPA). The registration of Class I medical devices is intended to ensure that these devices meet basic safety and effectiveness standards before they can be marketed in China.

Key Steps for NMPA Class I Registration of Medical Devices

1. Determine if the Device is Class I

Class I medical devices in China are those with a low risk to the human body. These devices are typically non-invasive, simple in structure, and do not require clinical trials. Examples include bandages, thermometers, and simple diagnostic devices.

To determine whether your device qualifies as a Class I device under NMPA’s classification system, you must refer to the Catalog of Medical Devices issued by the NMPA. If the device is listed as a Class I medical device, you can proceed with the registration process.

2. Establish a Legal Entity or Authorized Representative in China

• Foreign manufacturers must appoint a local authorized agent (also known as a China-based representative). This representative must be based in China and has the responsibility of submitting the registration on behalf of the manufacturer.
• Domestic manufacturers can apply directly to NMPA for Class I registration.

The authorized agent or domestic manufacturer will be the primary point of contact with the NMPA and will handle all documentation, submission, and communication with the authorities.

3. Prepare Required Documentation

For Class I registration, the NMPA requires less documentation than for higher-risk devices (Class II and Class III), but still requires the following basic information:

• Device description: A detailed description of the medical device, including its intended use, design, and functions.
• Manufacturing information: Details about the manufacturing process, quality control procedures, and compliance with Good Manufacturing Practice (GMP) standards.
• Labeling: Product labels and instructions for use (IFU), all in Chinese, as per NMPA's guidelines. This includes the device name, manufacturer details, product specifications, and usage instructions.
• Quality Management System (QMS) certification: If applicable, evidence that the manufacturer complies with ISO 13485 (Quality Management System for Medical Devices) or other relevant local standards.
• Product standard or specification: A product standard that shows how the device meets safety and performance requirements, such as ISO standards or equivalent standards relevant to the device.
• Declaration of conformity: A declaration by the manufacturer stating that the device meets relevant safety and regulatory requirements, including the Risk Management standards (such as ISO 14971).
• Sterility or biocompatibility reports: If applicable, documents proving that the device, or certain parts of the device, are sterile or biocompatible.

4. Submit the Registration Application

Once the documentation is prepared, the next step is to submit the application to the NMPA or its designated agency. The submission can be made through the NMPA's online portal, or in some cases, paper submissions are accepted, depending on the device type.

• Class I devices are subject to filing (not full registration). This means that the manufacturer must submit the required documents to NMPA for review and obtain filing approval rather than a registration certificate (as required for Class II and III devices).
• Online filing system: The NMPA’s filing process is increasingly done through an online system, where the applicant will create a submission, upload the required documents, and pay any applicable filing fees.

5. Review by NMPA

• The NMPA will conduct a review of the submitted documentation. The review will primarily focus on verifying the safety and effectiveness of the device and ensuring that the information provided is consistent and compliant with Chinese regulatory standards.
• Class I devices typically do not require clinical trials, but NMPA may still ask for additional supporting documents or clarifications if needed. The review process is generally shorter and less stringent than for higher-class devices.

6. Approval and Filing Confirmation

• If the application is complete and meets all regulatory requirements, the NMPA will issue a filing certificate for the device.
• Class I registration is a filing process, meaning the device is approved to be marketed in China without the need for the same level of review required for Class II or III devices. This approval is typically granted quickly after the submission is accepted.
• Manufacturers will receive a filing certificate, which confirms the device can be legally marketed in China.

7. Post-Market Obligations

Once the filing certificate is issued, the manufacturer is allowed to sell the device in China. However, there are ongoing post-market surveillance obligations:

• Adverse Event Reporting: Manufacturers must monitor the device’s performance in the market and report any adverse events or product complaints to NMPA.
• Product Recall: If necessary, the manufacturer must implement a recall process if the device is found to be unsafe or defective.
• Updates to Documentation: Any significant changes to the device (e.g., in design, manufacturing process, or labeling) must be updated and submitted to NMPA as needed.

8. Renewal of Filing

• Class I devices are typically not subject to the same periodic renewal requirements as Class II and III devices, but manufacturers should keep track of any updates to regulations that could impact their filing.
• If significant changes are made to the device or its manufacturing process, the manufacturer must notify NMPA and submit an updated filing.

9. Timeline for Class I Registration

The timeline for Class I registration is generally much faster than for higher-class devices because it involves a less stringent review process. Typically, it can take 2 to 4 months for NMPA to review and approve the filing, depending on the complexity of the device and the completeness of the submission. This timeline may be shortened if the manufacturer has a local representative or agent familiar with the process.

Key Considerations

• Documentation in Chinese: All documents must be submitted in Mandarin Chinese. If your company is based outside of China, working with a local agent or consultant fluent in both Chinese and regulatory requirements is critical.
• Compliance with Local Standards: Ensure compliance with local standards such as ISO 13485 and other relevant Chinese regulations, which could be audited by NMPA.
• Post-Market Surveillance: Even though Class I devices are less regulated, they still require the manufacturer to implement a post-market surveillance system to monitor product safety and report issues.

Conclusion

The NMPA Class I registration process for medical devices in China is relatively simple compared to Class II and III devices but still requires careful attention to regulatory documentation, submission procedures, and post-market obligations. By following the correct steps, ensuring accurate and comprehensive documentation, and working with local representatives if necessary, manufacturers can achieve a smooth and efficient registration process for their Class I medical devices in China.

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