The Medical Devices Performance Reports provide detailed metrics about the timeliness of pre-market medical devices review process against the performance service standards. The report compares five quarters, and the report is broken down by Parts of the Regulations and the applications types covered by them. Within the report, statistics are provided by submission type and show the number received, the number licensed the number in workload, the number of decisions and time to first decision against Cost Recovery service standards.
Applications Received are counts of submissions received during the Quarter using the filing date (AC date) which is the date the submission is considered received by Health Canada. Workload is the number of submissions "in process" on a given day. Backlog is the proportion of the workload that is over target Often the term workload is used to mean the amount of work received over a period of time and is a common source of confusion. Licences issued are a count of applications licenced after completion of scientific review. Decisions are points in the process where an action is recommended to license, reject, refuse, or request additional information, in regards to the application. First decision is measured from acceptance for review to the issuance of a licence or a request for further information (AI). Second decisions are measured from receipt of a response to an AI to a decision to license or issuance of a subsequent AI.
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