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STED coming to Canada

STED coming to CanadaHealth Canada will require Summary Technical Document (STED) format for Class 3/4 medical device submissions, according to the QA/RA.info blog.

The STED format for regulatory submissions is a harmonized submission format developed by the Global Harmonization Task Force (GHTF). GHTF promotes international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format.

In addition to Canada, STED continues to gain ground around the world. The EU system has encouraged the adoption of the STED as it fits well with the European technical documentation requirements.

In Asia, the Asian Harmonization Working Party is seeking views on the proposed Common Submission Dossier Template guidance document which is based on STED.

And in the U.S., FDA launched a STED pilot program several years ago.

Stay tuned for updates to the STED guidance document, which is expected later this year.

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