CFDA publishes new registration guidelines for ultrasound Doppler fetal monitor and ultrasonic dental equipment
John Li 2017-11-17 2017-11-27
CFDA publishes technical guidelines for the registration and review of 5 types of medical devices. The 5 types of medical devices are listed as follows:
- ultrasound Doppler fetal monitor
- ultrasound physiotherapy equipment
- ultrasonic dental equipment
- anti bedsore mattress
|Ultrasound Doppler Fetal Monitor Registration Guidelines (2017 revised version)
||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)
||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.
Out of scope: ultrasound treatment equipment causes tissue degeneration and/or coagulation necrosis
|Ultrasonic Dental Descaler Equipment Registration Guidelines (2017 revised version)
||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 is a part of a system, the guideline can also apply.|
|Perimeter Registration Guidelines (2017 revised version)
||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.
|Anti Bedsore Air Mattress Registration Guidelines (2017 revised version)
||This guideline applies to class II Prevent Bedsore Air Mattress.|