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Last month the Hong Kong Department of Health delayed release timelines for multiple new features of the Medical Device Information System (MDIS) to September 2024, including electronic submissions for adverse event and safety alert reports. Following a transition period, paper-based submissions are expected to be phased out by the end of the year. Background on MDISThe MDIS is a web-based appli..

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets. A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents suc..