FDA The new article covers specific aspects related to the Voluntary Improvement Program and regulatory procedures associated thereto. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and...
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...
FDA The new article describes in detail the activities to be undertaken in the context of participation in the Voluntary Improvement Program. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives...
FDA The article provides an overview of the regulatory measures intended to encourage medical device manufacturers to participate in the improvement of medical devices intended to be marketed and used in the US. The document constitutes a draft guidance the authority has...
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 The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
