The new article describes in detail the Essential Principles to be taken into consideration concerning medical devices intended to be marketed and used in Singapore. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
The article provides an overview of the regulatory framework related to the safety and performance requirements for medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
The new article highlights additional aspects related to the change notification process, including the turn-around time and fees. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
The new article describes in detail the approach to be applied by a party responsible for a medical device when notifying the regulating authority about the changes to the product already placed on the market. Table of Contents The Health...
The article provides an overview of the regulatory requirements related to change notification for medical devices that are already placed on the market. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency...