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ASEAN Draft Medical Device Directive Would Beef Up Adverse Event Reporting

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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. The 20-article draft directive — aimed at strengthening and harmonizing industry requirements in the region — focuses on requirements for device registration, labeling, risk classification and conformity assessment.
International Medical Device Regulatory Monitor