NMPA Class II Registration for medical devices in China is designed for devices that pose a moderate risk to patients or users. These devices require a more detailed regulatory review than Class I devices but are less stringent than Class III devices, which pose higher risks. Class II devices are typically subject to NMPA technical review, including evaluation of safety, efficacy, and compliance with Chinese regulations.

Here’s an overview of the requirements for NMPA Class II registration of medical devices in China:

1. Appointment of a Local Agent

For foreign manufacturers, it is mandatory to appoint a local agent or distributor in China to handle the registration process. The local agent will:

• Serve as the point of contact with the NMPA.
• Submit the registration application on behalf of the manufacturer.
• Ensure compliance with NMPA regulations and facilitate post-market surveillance.

2. Device Classification

Before starting the registration process, you must ensure that the device qualifies as a Class II medical device under the NMPA classification guidelines. Devices that fall under this category are typically those that:

• Are non-invasive (e.g., diagnostic equipment, dental instruments, or monitoring devices).
• Temporarily contact the body or are used in a more controlled environment (e.g., external diagnostic equipment, ultrasound systems).
• Have moderate risk of causing harm but are not life-supporting or life-sustaining (which would require Class III registration).

To classify your device, you can refer to NMPA’s Medical Device Classification Catalog or seek confirmation from NMPA directly if there is any uncertainty.

3. Regulatory Documentation Requirements

For Class II registration, the manufacturer needs to submit comprehensive documentation, which typically includes:

a. Application Form

A completed registration application form must be submitted to the NMPA through the official NMPA online submission system. This form will require basic details about the device and the manufacturer.

b. Product Technical Information

The technical documentation should include:

• Device specifications: Detailed descriptions of the device, its intended use, features, design, and materials.
• Performance characteristics: Information on the functionality of the device, including safety features and the technological principles it uses.
• Risk analysis: Assessment of potential risks associated with the use of the device, including failure modes and safety measures in place to mitigate those risks.

c. Clinical and Preclinical Data

• Clinical data: Depending on the device’s type and intended use, clinical trial data may be required to demonstrate its safety and effectiveness. For certain devices, clinical trials in China may not be required, but clinical data from other jurisdictions (e.g., FDA, CE mark) may be submitted as part of the application.
• Preclinical data: In cases where clinical data is not required, you may need to submit preclinical testing data. This can include biocompatibility testing, performance testing, and any lab-based evidence that demonstrates safety and functionality.

d. Labeling and Instructions for Use

You must provide the following:

• Product labeling in Chinese, including:
  • The device name, specifications, and intended use.
  • Instructions for proper operation and handling.
  • Warnings, contraindications, and precautions.
  • Storage and disposal instructions.

e. Manufacturing Information

• Evidence that the manufacturing facility complies with international quality standards (such as ISO 13485) and Chinese GMP (Good Manufacturing Practice) requirements.
• If the device is manufactured outside China, the facility will likely need to undergo an inspection by the NMPA or an NMPA-designated third-party agency.

f. Quality Management System

You will need to provide proof that the manufacturing process adheres to a quality management system (QMS), such as ISO 13485 certification. This ensures that the device is consistently manufactured according to safety and performance standards.

g. Testing and Inspection Reports

• If required, your device may need to undergo testing at an NMPA-designated laboratory in China. This could include:
  • Electrical safety testing.
  • Biocompatibility testing.
  • EMC (Electromagnetic Compatibility) testing.

The results of these tests, if applicable, must be submitted with the application.

4. Submission to NMPA

Once all documentation is prepared, the local agent will submit the application to the NMPA Center for Medical Device Evaluation (CMDE). This process can be done online through the NMPA's medical device registration system. In some cases, physical documents and samples may also need to be submitted to the NMPA for review.

5. Technical Review and Evaluation

After submission, the NMPA will initiate a technical review of the application, which typically includes:

• Document review: Verification of the submitted documents, including technical specifications, clinical data, and compliance with Chinese regulations.
• Product testing: The device may undergo product testing at an NMPA-designated laboratory, depending on the risk and type of device.
• On-site inspection: In some cases, the NMPA may inspect the manufacturing facility to ensure compliance with GMP and other quality management standards.

6. NMPA Decision

After the technical review, the NMPA will issue a decision regarding the application. This could include:

• Approval: The device will be granted a Medical Device Registration Certificate, allowing it to be sold in China.
• Additional Requirements: The NMPA may request further documentation or modifications before approving the device.
• Rejection: If the device does not meet NMPA's standards for safety, efficacy, or regulatory compliance, the application may be rejected.

7. Post-Market Requirements

Once registered, manufacturers must comply with post-market surveillance requirements, which include:

• Adverse event reporting: Manufacturers must report any adverse events or device malfunctions to NMPA.
• Annual reporting: Some devices may require annual updates to NMPA regarding their safety and performance in the market.
• Market inspections: The NMPA may conduct random inspections of medical devices on the market to ensure compliance with regulatory requirements.
• Quality control: Manufacturers must continue to maintain a quality management system throughout the lifecycle of the product.

8. Renewal of Registration

Class II registration certificates are typically valid for 5 years. To continue marketing the device in China, the manufacturer must apply for renewal before the certificate expires. The renewal process may involve updating the technical information and submitting post-market surveillance data.

Timeline for Class II Registration

• The NMPA registration process for Class II medical devices generally takes 6-12 months.
• The exact time may vary depending on the complexity of the device, the completeness of the application, and the need for clinical trials or testing.

Fees

There are application fees involved in the registration process. The cost varies depending on the device type and the complexity of the registration process, including testing and clinical trials.

Key Resources:

• NMPA Official Website: NMPA - National Medical Products Administration
• NMPA Medical Device Registration Guidelines: Detailed documents on the registration requirements are available on the NMPA website and can guide manufacturers on preparing the necessary application.

Conclusion:

NMPA Class II registration is designed for moderate-risk devices and requires a technical review, which includes an evaluation of product documentation, clinical and preclinical data, manufacturing standards, and possibly product testing. The process involves substantial documentation, and manufacturers must ensure that they meet the safety, efficacy, and quality requirements set by NMPA. If you have specific questions or need assistance in navigating the NMPA process for Class II devices, feel free to ask!

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