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China Promulgates Device Safety Monitoring Guidance

Q: What is the China Promulgates Device Safety Monitoring Guidance?



A: On September 16, 2011, the State Administration of Food and Drug (SFDA) unveiled the Tentative Guidance for the Monitoring of Adverse Device Events (Guidance). The Guidance specifies how device manufacturers, distributors, healthcare institutions and individuals should perform reporting, monitoring and re-evaluation in accordance with the Tentative Administrative Rules for the Monitoring and Re-Evaluation of Adverse Device Events promulgated by SFDA in 2008 (2008 Device Safety Rules).




Q: What are the main content of the Guidance?



A: Manufacturers as Primary Responsible Party



The Guidance requires device manufacturers to establish a management system for monitoring and reporting adverse device events, including (1) job descriptions for the function and staff responsible for monitoring and reporting, (2) training programs, (3) SOPs for identification, collection, investigation, analyses, evaluation, reporting and risk control of adverse device events, (4) SOPs for re-evaluation methods and process, (5) emergency plans for abrupt mass adverse events, (6) filing and archiving systems, and (7) the product tracing system. Manufacturers shall establish convenient and effective communication channels for the collection of adverse events.



Manufacturers of Class III implants must make such communication channels known in the Directions For Use of their products and through sales calls. If needed, manufacturers of such implants should offer technical trainings on the reporting system to users of the implants.



Manufacturers are expected to take prompt control measures after they discover any suspected serious adverse event, such as immediate suspension of sale and/or use and cooperation with healthcare professionals in the treatment of injured patients. The manufacturers should subsequently conduct internal investigations (such as retrospective study of product designs, inspection of quality systems, risk analyses, literature research, analysis of feedback from users and regulatory authorities, and quality testing) and on-site investigations to identify causes.



If serious adverse event causation is confirmed, the manufacturer must take remedial measures, including warning, inspection, repair, relabeling, amendment of the Directions For Use, upgrade of software, replacement, withdrawal, disposal, etc. and report to the local FDA and Adverse Event Monitoring Center where the adverse event occurred. These requirements will equally apply to agents of foreign medical device manufacturers marketing imported devices in China.



Enhanced Infrastructure for Reporting and Monitoring: Downstream Requirements



Distributors of medical devices and healthcare institutions are expected to establish systems and processes for the monitoring of adverse device events similar to that of a device manufacturer. Notably, healthcare institutions must assign an adverse event monitoring coordinator for each department where medical devices are used. This coordinator shall verify relevant facts of an adverse event, e.g. patient information, treatment course, consequences of the adverse event, how the subject device was applied, stored, maintained, etc., and identify the cause for the adverse event together with healthcare professionals using the subject device. Adverse event reports received by department coordinators shall be consolidated in a dedicated function in charge of adverse event monitoring at the healthcare institution.


In addition, food and drug administrationís at county, municipal, provincial and state levels are all expected to form a dedicated technical department responsible for the organization, implementation and administration of technical support pertinent to adverse event monitoring and reporting. Full-time personnel ranging from 2 (county level) to 15 (state level) are expected to be staffed at the technical department.



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