Overview:
Recently, the State Food and Drug Administration (SFDA) organized quality supervision and sampling of 81 batches (units) of products of five varieties of natural latex rubber condoms, etc., and some of the products produced by Xi'an Sterilization and Disinfection Equipment Manufacturing Company and other enterprises were not compliant. The General Administration of Food and Drug Administration requires the relevant provincial food and drug supervision and management departments to urge enterprises to identify the causes as soon as possible, to develop corrective measures and rectification in place on schedule, the relevant dispositions before February 28, 2017 to the community.
Details:
The notification shows that the sampling items do not meet the standard provisions of the medical device products, involving three medical device manufacturers of three varieties of three batches (units). Specifically:
(a) radiofrequency ablation equipment 1 enterprise 1 product. Xi'an Sterilization and disinfection equipment manufacturing company produced 1 radio frequency temperature-controlled thermal coagulators, the input power does not meet the standard provisions.
(ii) surgical gowns 1 enterprise 1 batch of products. Fenghua Kangjiale medical equipment Co., Ltd. production of a batch of single-use surgical gowns, blocking microbial penetration, wet state does not meet the standard provisions.
(C) natural latex rubber condoms 1 enterprise 1 batch of products. Qingdao London Durex Co., Ltd. production of a batch of natural latex rubber condoms, without aging burst volume and burst pressure does not meet the standard requirements.
The sampling test items for the identification of labels, instructions and other items do not meet the standard provisions of the medical device products, involving a medical device manufacturer of a variety of 1 unit, specifically:
Non-invasive automatic measurement of sphygmomanometer (electronic sphygmomanometer) 1 enterprise 1 product. Ltd. of Tianjin Jiasian medical equipment production of 1 electronic sphygmomanometer, labeling does not meet the standard provisions.
On the above sampling test found in the non-compliance with the standard provisions of the product, the State Food and Drug Administration required the enterprise location of food and drug supervision and management departments in accordance with the "supervision and management of medical devices regulations" and "Food and Drug Administration Office on further strengthening the work of sampling and testing of medical devices notice" (Food and Drug Administration Office of the Equipment Supervision 〔2016〕 No. 9), the relevant enterprises to investigate and deal with.
Related medical device manufacturers should carry out risk assessment of non-compliant products and non-compliant items, determine the recall level according to the severity of medical device defects, take the initiative to recall and publicize the recall information. Food and drug supervision and management department where the enterprise is located to supervise the recall of the enterprise, not organized recall should be ordered to recall; such as the discovery of non-compliance with the standard provisions of the medical device products on the human body to cause harm or evidence that may endanger human health, can be taken to suspend the production, importation, operation, use of the emergency control measures.