The State Food and Drug Administration has recently issued the Guidelines for the Monitoring of Medical Device Adverse Events (for Trial Implementation), requiring medical device manufacturing companies, operating companies, and users to use them on the day of discovery or knowledge after a suspicious medical device accident causing death. Within 5 working days, report to the local technical institution for medical device adverse event monitoring. Relevant companies and units may report to each other according to the situation.
The "Guide" stipulates that when deemed necessary, relevant companies and organizations may report at a leapfrog level, but they shall promptly notify the surviving technology monitoring agencies for medical device adverse events in the province (region, city) where they were crossed.
The "Guide" stipulates that when deemed necessary, relevant companies and organizations may report at a leapfrog level, but they shall promptly notify the surviving technology monitoring agencies for medical device adverse events in the province (region, city) where they were crossed.
Hunan Kangfutai Medical Devices Co., Ltd. , https://www.3kfut.com