Home > Newsletters > International Medical Device Regulatory Monitor > ASEAN Draft Medical Device Directive Would Beef Up Adverse Event Reporting
International Medical Device Regulatory Monitor
August 2012 | Vol. 20 No. 8
ASEAN Draft Medical Device Directive Would Beef Up Adverse Event Reporting
Countries in the Association of Southeast Asian Nations (ASEAN) would have to establish postmarketing surveillance alert systems to report and evaluate device-related adverse events and make the information available to other member states under a draft medical device directive released for comment this summer.
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