Japan Summary Technical Document (STED) Preparation for Medical Device Registration

The Summary Technical Document (STED) format was developed by the Global Harmonization Task Force (GHTF) and is a harmonized submission format. STED allows for a common submission format for various countries, including Japan, Australia, Canada, the US, and the EU.

STED is to demonstrate conformity to the essential principles of safety and performance of medical devices. This summary of technical documents according to STED format needs to be attached to applications for marketing approval.

PBM can help assemble your STED and make sure it complies with the applicable regulations.

For more information on medical device registration in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.

Japan Medical Device Updates (webcast for sale)
Updates on Japan's Expanding Medical Device Market (webcast for sale)
Strategies for Success in China, Japan, and India (webcast for sale)
New Japanese Medical Device Regulations (webcast for sale)

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