Fujian investigating a case of medical device violation

Recently, the Food and Drug Administration of Zhenghe County, Fujian Province investigated and dealt with a case in which a medical institution illegally purchased three types of medical devices.

After investigation, the "one-time use of vacuum blood collection needle matching needle" used by the medical institution was purchased from a company in Fuzhou. Law enforcement officers carefully checked the sales documents provided by the supplier company and the “medical device operating enterprise license” and discovered that the scope of the company’s operations did not include the use of disposable vacuum blood collection needles. Law enforcement officers detained 10 bags of illegally used medical devices on the spot, with a case value of 250 yuan.

The parties purchased three types of medical devices from unqualified companies in violation of the relevant provisions of Article 18 of the "Regulations on the Supervision and Management of Medical Devices" and Article 18 of the "Administrative Measures for the Circulation of Drugs and Medical Devices in Fujian Province". The county bureau shall, in accordance with the provisions of Article 42 of the "Regulations on the Supervision and Administration of Medical Devices", order corrections, confiscate medical devices illegally used, confiscate 250 yuan of illegal income, and dispose of a fine of 5,000 yuan.