CFDA Continues Medical Device Quality Drive
China Food and Drug Administration (CFDA) has released another document about the quality of medical devices. The regulator's latest missive moves its focus further down the supply chain to address quality aspects of the procurement, storage, use and maintenance of medical devices.
CFDA has published the document to address what it sees as shortcomings in how medical devices are handled as they leave the factory and enter the final steps of the healthcare supply chain. In a notice to accompany the document, CFDA highlights the lack of standardized procurement channels for medical devices, the failure to inspect purchases and the lax approach to maintenance as issues with the current system.
Officials at CFDA are aiming to improve the system by changing how the industry approaches several steps in the supply chain. The new guidance calls for buyers of medical devices to thoroughly inspect supplier qualifications and product documentation while also maintaining records of their activities. Once a device is acquired, CFDA wants healthcare providers to ensure it continues to work as intended by implementing a maintenance program.
The release of the medical device management document comes weeks after CFDA published four sets of guidelines about medical device good manufacturing practices (GMPs) and its approach to on-site inspections. In the past year, CFDA has also committed to performing surprise inspections of medical device manufacturers and updated the GMP regulations that cover the industry. The latest procurement and storage-focused document is set to come into force on 1 February 2016
CFDA Continues Medical Device Quality DriveChina Food and Drug Administration (CFDA) has released another document about the quality of medical devices. The regulator's latest missive moves its focus further down the supply chain to address quality aspects of the procurement, storage, use and maintenance of medical devices.CFDA has published the document to address what it sees as shortcomings in how medical devices are handled as they leave the factory and enter the final steps of the healthcare supply chain. In a notice to accompany the document, CFDA highlights the lack of standardized procurement channels for medical devices, the failure to inspect purchases and the lax approach to maintenance as issues with the current system.Officials at CFDA are aiming to improve the system by changing how the industry approaches several steps in the supply chain. The new guidance calls for buyers of medical devices to thoroughly inspect supplier qualifications and product documentation while also maintaining records of their activities. Once a device is acquired, CFDA wants healthcare providers to ensure it continues to work as intended by implementing a maintenance program.The release of the medical device management document comes weeks after CFDA published four sets of guidelines about medical device good manufacturing practices (GMPs) and its approach to on-site inspections. In the past year, CFDA has also committed to performing surprise inspections of medical device manufacturers and updated the GMP regulations that cover the industry. The latest procurement and storage-focused document is set to come into force on 1 February 2016
การแปล กรุณารอสักครู่..