In China, the National Medical Products Administration (NMPA) (formerly the China Food and Drug Administration, or CFDA) regulates medical devices based on a classification system that determines the regulatory requirements for device registration. The types of medical devices subject to NMPA registration are divided into three classes based on the potential risk they pose to patients and users. These classes help define the level of scrutiny a device will undergo in the registration process.

1. Class I: Low Risk Devices

Class I devices are considered low-risk and are subject to the least regulatory control. These devices do not require clinical trial data, and the registration process is generally simpler. They are typically devices that pose minimal risk to the human body and are intended for general medical use.

• Examples of Class I devices:
  • Non-invasive thermometers
  • Manual surgical instruments (e.g., scissors, forceps)
  • Medical gloves
  • Bandages and dressings
  • Basic diagnostic devices (e.g., stethoscopes, blood pressure cuffs)

Class I devices are subject to filing with the NMPA rather than full registration. The manufacturer submits basic documentation, including product information, quality control systems, and evidence of compliance with relevant standards.

2. Class II: Moderate Risk Devices

Class II devices are considered moderate-risk and typically require more regulatory control than Class I devices. These devices may require additional testing (such as performance testing) and some may need clinical trial data, depending on the nature of the device.

• Examples of Class II devices:
  • Infusion pumps
  • X-ray machines
  • Ultrasound equipment
  • Electrosurgical equipment
  • Anesthesia machines
  • Endoscopes
  • Hearing aids
  • Dental implants
  • Monitoring equipment (e.g., ECG machines, blood glucose meters)

Class II devices generally require registration, which involves submitting technical documentation, performance and safety testing data, and, in some cases, clinical trial results.

3. Class III: High Risk Devices

Class III devices are considered high-risk and include those that are intended to support or sustain life, prevent impairment of health, or have a significant impact on patient health if they malfunction. These devices are subject to the most stringent regulatory requirements, including clinical trials and extensive technical documentation to prove safety and effectiveness.

• Examples of Class III devices:
  • Implantable devices (e.g., pacemakers, prosthetic heart valves)
  • Ventilators and respirators
  • Defibrillators
  • Dialysis machines
  • MRI equipment
  • Cardiac stents
  • Surgical lasers
  • Blood bags and transfusion equipment
  • Surgical robots

Class III devices require full registration, which involves submitting comprehensive technical documentation, clinical trial data, performance testing, and often an on-site inspection by the NMPA.

Additional Key Notes:

• Clinical Trials: Class III devices and some Class II devices may require clinical trial data to support their safety and efficacy claims. The NMPA reviews the results from these trials as part of the registration process.
• Manufacturing and Quality Control: All devices, regardless of classification, must demonstrate compliance with China’s Good Manufacturing Practices (GMP) and other regulatory requirements, such as ISO 13485 for quality management systems.
• Foreign Manufacturers: If the device is manufactured outside China, the manufacturer must designate a Chinese agent to handle the NMPA registration process and to communicate with the NMPA on their behalf.
• Product Classification: The classification of a medical device (Class I, II, or III) is determined based on the risk of the device. The NMPA will provide guidance on the classification if manufacturers are unsure.

For a successful NMPA registration process, manufacturers should work closely with regulatory consultants or local agents who are familiar with the NMPA's requirements, particularly for higher-risk devices in Class II and III.