Notifying Changes To Marketed Devices In Singapore Becomes Easier From Dec. 1
This article was originally published in SRA
Singapore's Health Sciences Authority has adopted a revised policy that will make it easier for medical device companies to notify the agency of any changes they make concerning a marketed device1,2. The revised policy, issued in the form of an updated guidance, will apply to "change notification" applications submitted by companies as of Dec. 1 when the policy comes into effect.
You may also be interested in...
New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.
Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.
In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.