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Hong Kong initiates registration of high-risk medical devices

This article was originally published in RAJ Devices

Executive Summary

Hong Kong’s Medical Device Control Office has initiated a voluntary product registration drive to kick-start the first phase of its new in vitro diagnostic regulatory framework1. The framework is in line with the principles of the Global Harmonization Task Force and classifies products into four categories (Classes A to D) according to their risk level, with Class D denoting the highest-risk products2.

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