As ComplianceAcuity previously reported in August 2009, Health Canada’s Medical Devices Bureau issued a notice proposing to fully implement the use of the GHTF STED format for Class III and IV premarket Medical Device License Applications by July 1, 2010.
On June 17th, Health Canada announced that the full STED implementation will be delayed for an extra year, until July 1, 2011, to allow for additional work and industry feedback on the Medical Devices Bureau’s new guidance document outlining Canadian regulatory submission requirements for Class III and IV medical device license applications submitted using the STED format. The new guidance document will replace the current guidance document entitled “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”.
In the interim, the Bureau will continue to accept Class III and IV premarket review documents in the usual format, as well as class III and IV non-in vitro diagnostic device applications submitted using the STED format voluntarily under the Bureau’s January 1, 2001 pilot program and corresponding fact sheet. On that note, although originally intended to run for only one year and to apply to only a specific subset of devices, the Bureau’s Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau) confirmed to DeviceWise that the pilot program has been extended indefinitely, and that it may now be used for all class III and IV non-in vitro diagnostic devices. Ms. Chandler also emphasized that the Bureau is encouraging the voluntary use of the STED format instead of the usual format.