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    CFDA Issued Ten New Medical Device Registration Guidelines

    November 15th 2017, China Food and Drug Administration (CFDA) issued ten new registration guidelines. 

    Guideline List

    • Ultrasound Doppler Fetal Monitor Registration Guidelines (2017 revised version)

    • Ultrasonic Physiotherapy Equipment Registration Guidelines (2017 revised version)

    • Ultrasonic Dental Descaler Equipment Registration Guidelines (2017 revised version)

    • Perimeter Registration Guidelines (2017 revised version)

    • Prevent Bedsore Air Mattress Registration Guidelines (2017 revised version)

    • Ultrasound Bone Sonometers Registration Guidelines

    • Electric Wheelchairs Registration Guidelines

    • Ear Cavity Type Medical Infrared Thermometer Registration Guidelines

    • Medical Suction Equipment Registration Guidelines (2017 revised version)

    • Small Molecular Sieve Oxygen Generator Registration Guidelines (2017 revised version)


    Guideline Applicable Scope
     

    GuidelineApplicable Scope
    Ultrasound Doppler Fetal Monitor Registration Guidelines (2017 revised version)
    CN:超声多普勒胎儿监护仪注册技术审查指导原则(2017年修订版)
    This guideline applies to class II Ultrasound Doppler Fetal Monitor. The definition use the YY 0449—2009 ‘Ultrasound Doppler Fetal Monitor’ 3.1. It is composed of mainframe, ultrasonic probe pressure sensor, contractions pressure sensors and the connected instrument. It uses the ultrasonic doppler principle. It has the function of monitoring, storing the data of fetal heart rate and alarm setting. If the Ultrasound Doppler Fetal Monitor as a part of a system, the guideline can also apply.  
    Not apply to: Ultrasonic Doppler fetal heartbeat detector. This medical device will use industry standard 
    YY 0448—2009 Ultrasonic Doppler fetal heartbeat detector.
    Ultrasonic Physiotherapy Equipment Registration Guidelines (2017 revised version)
    CN:超声理疗设备注册技术审查指导原则(2017年修订版)
    This guideline applies to Ultrasonic Physiotherapy Equipment with the frequency range of 0.5MHz—5MHz. Ultrasonic physiotherapy equipment generates continuous wave or quasi-continuous ultrasonic energy by plane circular ultrasonic transducer. The effective acoustic intensity is not greater than 3W/cm2. If the Ultrasonic Physiotherapy Equipment as a part of a system, the guideline can also apply to. From the point of view of medical device regulatory, ultrasonic treatment equipment including: ultrasonic treatment equipment, ultrasonic surgical equipment, ultrasonic cleaning equipment, non physical therapy equipment and high intensity focused ultrasound treatment equipment and so on.  
    Not apply to: ultrasound treatment equipment causes tissue degeneration and/or coagulation necrosis
    Ultrasonic Dental Descaler Equipment Registration Guidelines (2017 revised version)
    CN:超声洁牙设备注册技术审查指导原则(2017年修订版)
    This guideline applies to Class II Ultrasonic Dental Descaler Equipment with the frequency range of 18kHz—60kHz. Ultrasonic transducer produces continuous or quasi-continuous ultrasonic energy for dental cleaning. If the Ultrasonic Dental Descaler Equipment as a part of a system, the guideline can also apply to.
    Perimeter Registration Guidelines (2017 revised version)
    CN:视野计注册技术审查指导原则(2017年修订版)
    This guideline applies to class II Perimeter in the ophthalmic optical instruments. It is powered by grid power. The optical sensitivity of the field of vision was evaluated by the patient's subjective perception of the existence of the test stimulus in a certain background.
    Not apply to: the devices that are primarily controlled by artificial testing strategies.
    Prevent Bedsore Air Mattress Registration Guidelines (2017 revised version) 
    CN:防褥疮气床垫注册技术审查指导原则(2017年修订版)
    This guideline applies to class II Prevent Bedsore Air Mattress.
    Ultrasound Bone Sonometers Registration Guidelines
    CN:超声骨密度仪注册技术审查指导原则
    This guideline applies to class II Ultrasound Bone Sonometers of the ultrasonic physiological parameter measurement and analysis equipment. It test through the ultrasound speed (sos) and/or wide-band ultrasonic attenuation (BUA) of heel bone, tibia and/or radius to reflect the skeletal density condition
    Electric Wheelchairs Registration Guidelines
    CN:电动轮椅车注册技术审查指导原则
    This guideline applies to class II Electric Wheelchairs that are powered by electric energy only by taking 1 person and the user with no more than 100 kg of disability or no complete walking ability.
    Not apply to: The electric Wheelchairs more than 100 kg, but it can use the ISO 7176 as a reference. This guiding principle does not apply to manual wheelchairs and electric vehicles powered by electricity.
    Ear Cavity Type Medical Infrared Thermometer Registration Guidelines
    CN:耳腔式医用红外体温计注册技术审查指导原则
    This guideline applies to the infrared temperature sensor is used to measure the infrared radiation exchange and proper correction of the human ear cavity. The output shows the ear cavity type medical infrared thermometer that is measured in a certain part of the human body.
    Medical Suction Equipment Registration Guidelines (2017 revised version)
    CN:医用吸引设备注册技术审查指导原则(2017年修订版)
    This guideline applies to class II medical vacuum suction device that confirmed to YY0636, including electric suction device, artificial drive suction device, and negative pressure source as the power to attract equipment.
    Not apply to: Terminal piece (suction tube and suction head)
    Small Molecular Sieve Oxygen Generator Registration Guidelines (2017 revised version)
    CN:小型分子筛制氧机注册技术审查指导原则(2017年修订版)
    This guideline applies to the small molecular sieve oxygen generator for oxygen-rich air (93% oxygen) or medical oxygen (oxygen generator) as class II medical devices.
    Not apply to: Vehicle-mounted medical oxygen generator, medical oxygen machines used in flammable anesthetic gases and/or cleaning agents or medical oxygen machine that supplies gas to a number of patients through a pipeline of medical gases.
     


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