28
edits
Changes
→Pre-market/licensing summary
==== Pre-market/licensing summary ====
==== Pre-market/licensing summary ====
The pre-market and licensing summary details the licence history of a device as well as the history of applications that include the device.
==== Special Access Summary ====
==== Special Access Summary ====
The Special Access Summary lists the special access requests made for the device, along with the request dtae and action date, and whether the request was approved or not.
==== Special Access Info ====
==== Special Access Info ====
The Special Access Info tab lists some characteristics about the indication of the device, future considerations, and the status (active or inactive). I also captures licence alternatives.
==== Incident Summary ====
==== Incident Summary ====
This section summarizes the incidents recorded for the device; the word incident in this setting relates to anything that would be recorded in the incident section, which includes recalls, complaints, as well as mandatory medical device problem reports. On deployment of the medical device sections of the ArisG system on February 3, 2020, most of the incident data was migrated to this new system, leaving only the recall incidents to continue to be recorded. Due to a variety of challenges with the new system as well as the costs of licensing, the Regulatory Operations and Enforcement Branch (ROEB) is planning to migrate their records and work back to the MDS system sometime in 2022. This will result in a system in which the data for mandatory problems is entered and stored in a different system than voluntary reports, trade complaints, and recalls.
===Company Section===
===Company Section===