Overseas Reporting System for Medical Device Adverse Events Launched
Release time:
2018-08-08
Overseas Reporting System for Medical Device Adverse Events Launched
(Source: China Medical Device Industry Association Polymer Products Branch)
The development and trial operation of the overseas reporting module of the National Adverse Drug Reaction Monitoring System have been completed recently. From May 1, 2013, the agents of medical device manufacturing enterprises and overseas medical device manufacturing enterprises in China shall follow the requirements of Article 36 of the Measures for the Administration of Monitoring and Re-evaluation of Adverse Events of Medical Devices (Trial), that is, for products that are listed and sold both in China and abroad, the adverse events of medical devices that cause or may cause serious injury or death and the control measures taken by its related products abroad shall be reported in the "National Adverse Drug Reaction Monitoring System" within 15 days from the date of discovery.
The launch of the overseas reporting module has realized the direct network reporting of overseas reports of medical device adverse events, improved the reporting efficiency, standardized the reporting content, and further improved the medical device adverse event reporting system.
Annex Website:Medical Device Adverse Event Monitoring Platform-User Manual for Overseas Reporting
http://www.cdr.gov.cn/xwdt/201304/t20130428_5443.html
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