In order to further improve the risk management and quality control capabilities in the operation and use of medical devices, strengthen the quality and safety management of medical devices, standardize the operation and use of medical devices, and ensure the safe and effective use of medical devices in the jurisdiction, a normalized supervision model for medical devices is established. Recently, the Market Supervision and Administration Bureau of Zhangxian County, Gansu Province, China launched a special inspection on the operation and use of medical devices.
This special inspection focuses on the purchase and use of sterile and implantable medical devices, medical devices for epidemic prevention and control, selected medical devices for centralized and volume procurement, stomatology devices, ophthalmology measurement and diagnosis equipment and instruments, and stickers. Whether it is registered or filed in accordance with the law, whether there are conformity certification documents and expired, invalid, or obsolete medical devices; whether the qualifications of suppliers and product certification documents are strictly checked; whether the storage conditions of medical devices meet the labeling requirements of labels and instructions, and cold chain management is required Whether the medical device is equipped with appropriate facilities and equipment; whether it fulfills the obligations related to the monitoring of adverse events of medical devices, etc. The inspection found that some medical device business and use units failed to review the legality of suppliers and purchased medical devices in accordance with regulations, failed to establish complete medical device supplier qualification files, irregular management of medical device purchase and sales bills, and medical device display areas. Failure to set up obvious signs as required, etc.
In response to the problems found in the inspection, the law enforcement officers put forward rectification opinions on the spot, and guided the rectification on the spot, which have been basically implemented and will be supervised for further improvement in the later stage. Cases were filed and investigated for 5 companies that had illegal business and use behaviors, and 3 cases have been settled, with a fine of 6,000 yuan.
Another Chinese company, ALPS, strictly abides by market supervision, and its disposable syringes are well-received by the market.
Post time: Jun-14-2022