Notice to Industry - Pilot Premarket Review Program for Medical Devices

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Contact DEVICE_LICENSING

The Therapeutic Products Directorate (TPD) is announcing the start of a pilot premarket review program for medical devices on January 1, 2001 and is soliciting participation from the medical devices industry. The pilot program is to evaluate the utility of a document developed by the Global Harmonization Task Force (GHTF), Study Group 1, entitled "Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)".

The pilot program is being undertaken in a number of participating countries represented on the GHTF. It is envisaged that the pilot program will run for one year until December 2002, but this may vary depending on the level of participation by industry. At the conclusion of the study, SG1 will evaluate the findings from different regions.

Further information on the pilot program including a Fact Sheet and Guidance for Manufacturers preparing a Premarket Application Using the Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices is available on our website at:

http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/fs-fi/index-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/index-eng.php

Contact
Nancy Shadeed, Medical Devices Bureau
TEL: (613) 954-0285, FAX: (613) 957-6345