Asia 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...
Asia The article provides an overview of the regulatory requirements and procedures related to the importation of medical devices. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
Asia 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...
Asia 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...
Asia 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...
Asia The article highlights the most important aspects associated with the declaration of conformity to be issued by a party responsible for a medical device to demonstrate compliance with the applicable safety and performance requirements. ...
