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Singapore Eases Registration Process for Some Devices
Devices Regulatory Affairs
Singapore’s Health Science Authority announced changes to legislation that will allow faster access to certain low-risk medical devices and stand-alone mobile applications.
The authority is also updating its policies with more detail on requirements for telehealth devices and high-risk devices that modify appearance or anatomy.
Beginning June 1, about 75 percent of Class B medical device applications will be granted immediate market access, HSA said. Currently, Class B registration takes about 60 days for a product to be registered.