7 More Cases Reported on Illegal Use of Beauty Devices and Penalties
In addition to the six cases reported last month, the NMPA (National Medical Products Administration) issued an announcement on December 24, 2021, with another list of violations committed by medical beauty service providers in China.
The respective AMR (Administration for Market Regulation) officials reported the following violation cases for the use of unregistered medical devices and confiscated the products involved:
Changchun AMR – May 10, 2021
The medical beauty clinic was found without indicating any Chinese labels of the product, and was fined 330250 yuan for using an unregistered medical device.
Daqing AMR – August 5, 2021
The medical beauty clinic was found without indicating any Chinese labels of 270 sterile needles, and was fined 25000 yuan for using an unregistered medical device.
Hangzhou AMR – June 8, 2021
The medical beauty clinic was found without indicating any Chinese labels of Hyaluronic acid , and was fined 1096058.21 yuan for using an unregistered medical device.
Linyi AMR – September 16, 2021
The medical beauty clinic was found without indicating any Chinese labels of products, and was fined 29000 yuan for using an unregistered medical device.
Dengzhou AMR – November 8, 2021
The medical beauty clinic was found without indicating any Chinese labels of Hyaluronic acid , and was fined 50000 yuan for using an unregistered medical device.
Zhuhai AMR – April 30, 2021
The medical beauty clinic was found without indicating any Chinese labels of needles, and was fined 35000 yuan for using an unregistered medical device.
Guiyang AMR – January 29, 2021
The medical beauty clinic was found without indicating any Chinese labels of Sodium hyaluronate, and was fined 20000 yuan for using an unregistered medical device.
Due to the strict monitoring of beauty devices used in China, manufacturers should always be aware of the regulatory changes to ensure their product complies with the mandatory requirements at all times.
Strict Rules for Beauty Services in Shandong
On December 9, 2021, the Shandong MPA announced 12 rules of using medical devices for beauty service providers in the Shandong province:
6 Rules for Prohibited Actions
- Prohibition of purchasing or using medical devices that are not registered or filed as required by law.
- Prohibition of purchasing medical devices from enterprises without legal qualification.
- Prohibition of using medical devices that do not meet mandatory standards or registration/filing product technical requirements.
- Prohibition of using medical devices without qualified certificates.
- Prohibition of using expired, invalid or obsolete medical devices.
- Prohibition of using imported medical devices without user manuals or labeling in Chinese.
6 Rules for Compulsory Actions
- A recordkeeping system for the inspection of incoming medical device products must be established and implemented according to the requirements.
- Properly keep the original data information of the class III medical devices purchased.
- Medical devices must be stored and used in accordance with the user manual and labeling requirements.
- Medical devices must be checked, inspected, calibrated, maintained and recorded in accordance with the requirements listed in the user manual.
- The necessary information on the use of large medical devices and implantable and interventional medical devices must be recorded in the medical records and other relevant records in accordance with the regulations.
- Monitoring and reporting of adverse events of medical devices must be carried out in accordance with regulations.
The newly revised regulations on the supervision and administration of medical devices has been implemented on June 1, 2021. Violation of the above circumstances will be punished according to law.
By Alice Liu and Jacky Li. Contact Cisema if you would like to learn more.
