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. 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