“Provisions for Medical Device Standards” and 4 new guidelines and have been released by CFDA from April 26th to April 27th. Even though they are called guidelines, once they are released, you are expected to comply with them whether your products are in the review phase or new submissions. If you need any detailed information regarding these guidelines and how they impact your devices in China, please contact us at info@ChinaMedDevice.com .
1. On April 27th, CFDA issued a technical review guideline on ultrasonic Doppler foetal heartbeat detector.
Its class code is 6823.
This guideline applies to ultrasonic Doppler foetal heartbeat detector that obtain fetal heart movement information from pregnant woman according to the principle of Doppler. It does not apply to continuous fetal heart rate monitoring devices with multiple flat ultrasound Doppler transducers.
2. On April 27th, CFDA issued a technical review guideline on electric traction device.
Its class code is 6826.
This guideline applies to products related with electric traction device.
Electric traction devices for spicule traction and fast traction are not included in this guideline.
3. On April 27th, CFDA issued a technical review guideline on electric operating table.
Its class code is 6854.
This guideline applies to electric operating table that was defined in “Medical Device Classification List” and “Electric Operating Table(YY/T 1106-2008)”.
It does not apply to field operating table.
4. On April 27th, CFDA issued a technical review guideline on imaging ultrasonic diagnostic equipment.
It is Class II with class code 6823.
This guideline applies to grayscale imaging system in the second type of imaging ultrasound diagnostic equipment.
5. On April 26th, CFDA issued a modified version of “Provisions for Medical Device Standards”.
The Provisions for Medical Device Standards was adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, and shall be effective as of July 1, 2017.
The promulgation of the Provisions for Medical Device Standards will play a positive role in guiding China’s standardized management of medical devices, regulating the formulation and revision of standards, promoting the implementation and improvement of standards, and improving the quality of medical devices.
Here are the modifications:
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