What is the purpose of implementing the "Code for the Quality Management of Medical Devices Business"?
The purpose of implementing the "Code for the Quality Management of Medical Device Operation" is to strengthen the quality management of medical device operation, standardize the behavior of medical device operation, promote the standardized development of the industry, and ensure the safety and effectiveness of the public use of equipment. According to the query Chinese people *** and the Central People's Government of the State Drug Administration on the release of the medical device business quality management standard of the announcement that, in order to strengthen the medical device business quality management, standardize the behavior of medical device business, promote the industry standardization and development, to protect the public with the device safety and effective, according to the relevant laws and regulations, the State Drug Administration revised the "medical device business quality management standard". The new version of the "Code of Practice for the Quality Management of Medical Devices Business" in the unique identification of medical devices in the quality of institutional responsibilities, the third type of business computer systems, business product qualification audit, the content of the purchase inspection records, the content of the record of the outgoing review, the content of the record of the return of goods or the return of storage and many other provisions, have proposed "unique identification of medical devices" and "traceability" and "medical devices". "The company also encourages the development of digitalization and intelligentization of enterprises to improve the efficiency and quality safety of medical device supply chain and promote the high-quality development of the industry.