International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Hong Kong launches device regs: Department of Health releases 1public consultation paper July 4 on proposed regulatory framework addressing Hong Kong's lack of device premarket controls, formal adverse event reporting system and surveillance network. A new risk-benefit approach, in line with Global Harmonization Task Force principles, requires registration and personnel limits for higher-risk devices. DoH will hold three public forums in July on the consultation, which expires Sept. 30. An administrative control system proposal is scheduled for implementation next year...