www.fdanews.com/articles/187099-singapore-eases-registration-process-for-some-devices
Singapore Eases Registration Process for Some Devices
June 5, 2018
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.