On January 5, 2021, the National Medical Products Administration (NMPA) issued an announcement to reinforce the requirements of the instructions for use (IFU) and related product information for ultrasonic couplants in China.
An ultrasonic couplant is the medium (in liquid form) applied to the human tissue to facilitate the transmission of ultrasonic energy from the ultrasonic probe during the diagnosis and treatment process.
The ultrasonic coupling agents can be categorized as sterile and non-sterile:
- Sterile coupling agents are used during invasive surgery and are considered Class II medical devices in China.
- Non-sterile coupling agents are used on intact skin and are considered Class I medical devices in China.
According to the announcement, the China registered ultrasonic coupling agents are required to comply with the mandatory industry standard YY 0299-2016, and applicants of non-sterile coupling agents must also bear in mind that wounds, non-intact skin and mucosa would be considered out of the product scope. Since any necessary filing changes of non-sterile coupling agents must be completed by the end of February 2021, applicants are required to update the respective information accordingly.
NMPA also reported a total of 282 class I ultrasonic couplants (276 domestic and 6 imported) registered in its database.
By Jacky Li. Contact Cisema if you would like to learn more.