For health canada medical device application, how to prepare the executive summary?

Below guidance does not address how to prepare it.

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/prmkt2_precomm2-eng.pdf


Thanks

Any comments?

I am writing one too, found this from the HC website:


Executive Summary
provides a contextual background and orientation regarding the
device application. For a new device licence application, the executive summary should
address the device indications for use, the various technologies employed by the device,
and the design rational. In the case of a device licence amendment application, the
executive summary should provide a description of the modifications made to the existing
licenced device, and include any changes to the licenced indications for use.

Do you have any template?

For health canada medical device application, how to prepare the executive summary?

Below guidance does not address how to prepare it.

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/prmkt2_precomm2-eng.pdf


Thanks

Have you tried to contact the people listed in the letter? That might be a starting point. Added in: Are you looking to create an Executive Summary or apply for a license?