The MPA called the roll and fined 6.32 million yuan to an enterprise!
2022-11-11
Since 2022, the major inspection of medical devices has been carried out continuously in many places throughout the country.
Recently, Hefei ** Medical Equipment Co., Ltd. was punished by the market regulator for producing disposable medical protective clothing without permission: 1. 6,800 medical disposable protective suits produced without licenses were confiscated. 2. Confiscation of production tools and serial production raw materials; 3. Confiscation of illegal income: 35360 yuan; 4. Fine: 6324000 yuan.
In addition, the supervision and inspection results of medical device enterprises in Henan Province, Jiangxi Province, Shaanxi Province and Gansu Province have also been released. Nearly 150 companies have products with substandard items, failed to pass the inspection, and faced administrative penalties such as fines and orders to make corrections.
Obviously, at the present stage, with the normalization of random inspection of medical devices, the scope of inspection of medical devices has gradually been regulated from production, circulation to use.
Especially in May this year, with the formal implementation of the revised Measures for the Supervision and Administration of the Production of Medical Devices and the Measures for the Supervision and Administration of the Operation of Medical Devices, the medical device industry will usher in the strongest era of supervision
