Just to add a few more comments about AEs and recalls in China. China NMPA does NOT have FDA/Maude type of open database. It only publishes periodic summary of certain products adverse events. What and when to publish these types of AE summary reports are determined by the NMPA's internal monitoring algorithms. NOT all AEs are made public in China for both overseas and domestic products. Only significant AEs in China is required to report. On the other hand, recalls are made public more readily. This is why you see 3111 vs 157 bulletins. I would expect more AEs reporting and surveillance in the future as NMPA starts to beef up its stuff in this area. The official implementation of Adverse Event Reporting and Reevaluation on Jan 1st 2019, Decree #1 followed by the recent regulation that further elaborated the required filing of AEs. O
n May 6, National Center for ADR Monitoring issued a notice "Issues on Implementation of Periodic Risk Assessment Reports for Medical Device Adverse Events". It requires annual filing annually for class II and III initial registration products. The Periodic Risk Evaluation Report is due end of May for the first time.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------
Original Message:
Sent: 07-Jun-2020 19:50
From: Qianqian Zhu
Subject: Chinese Adverse Event Database
NMPA Medical Device Adverse Events Database 医疗器械不良事件通报, http://www.nmpa.gov.cn/WS04/CL2157/.
The database has a total 44 bulletins.
National Center for ADR Monitoring (China) Database for Medical Device Alerts and Recall (Chinese) 医疗器械警戒快讯.
There are a total of 157 bulletins.
NMPA Database for Medical Device Recall (医疗器械召回) http://www.nmpa.gov.cn/WS04/CL2061.
The entire database has 156 pages, 3111 entries.
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Qianqian Zhu RAC
Lawrenceville GA
United States
Original Message:
Sent: 06-Jun-2020 14:03
From: Ethan Drower
Subject: Chinese Adverse Event Database
Does anyone know if there is a publicly available database of adverse events for medical devices in China? Similar to FDA/Maude?
Thank you!
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Ethan Drower
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