Medical device products will be traceable to inspection sales records

Source: www.medcine.com.cn on January 19, 2015, the reporter learned from the State Food and Drug Administration on March 16 that the newly revised "medical device production quality management specification" will come into effect on March 1, 2015 According to the specification, medical device enterprises shall establish product traceability procedures, and specify the scope, extent, identification and necessary records of product traceability According to reports, the introduction of the standard aims to strengthen the supervision and management of medical device production, standardize the quality management of medical device production, and further ensure the safety and effectiveness of public use of equipment The revised specification specifies equipment, procurement, production management, quality control, sales and after-sales, non-conforming product control, adverse event monitoring, analysis and improvement According to the standard requirements, the enterprise shall conduct production in accordance with the established quality management system, so as to ensure that the products meet the mandatory standards and the registered or filed product technical requirements, and establish the product traceability procedures In terms of quality control, enterprises shall formulate product inspection procedures in accordance with mandatory standards and registered or filed product technical requirements, and issue corresponding inspection reports or certificates Each batch (set) of products shall have inspection records and meet traceability requirements Inspection records shall include inspection records, inspection reports or certificates of incoming inspection, process inspection and finished product inspection For sales and after-sales service, the specification requires that enterprises should establish product sales records and meet the requirements of traceability The sales record shall at least include the name, specification, model and quantity of medical devices, production batch number, validity period, sales date, name, address and contact information of the buyer In addition, the standard also pointed out that enterprises should establish adverse event monitoring system for medical devices in accordance with the requirements of relevant laws and regulations, carry out adverse event monitoring and re evaluation, and keep relevant records For medical devices with potential safety hazards, recall and other measures shall be taken in accordance with the requirements of relevant laws and regulations, and report to relevant departments as required.