Health Canada issued a new guidance document entitled Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and Class IV Medical Device Licence Application.
This guidance, effective November 1, 2011, covers medical device licence applications and medical device licence amendment applications for both Class III and Class IV in vitro diagnostic devices (IVDDs) and non-IVDDs (medical devices). Therefore, as of November 1, 2011, all premarket review documents for Class III and Class IV medical device licence applications and licence amendment applications will be expected to be submitted in both paper and electronic formats and be structured and prepared using the specifications outlined in this notice.
The new guidance document refers to Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications published October 23, 1998 (http://www.hc-sc.gc.ca/dhp-mps/mdim/ applic-demande/guide-ld/prmkt2_precomm2-eng.php). together, they form the basis for submissions, but Sections 1.0 to 4.0 of the electronic folder structure differ from the paper-based guidance due to reorganization, however, no new content or forms are required.
You can obtain a copy of the new guidance from http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/activit/announce-annonce/notice_e-form_class_iii_iv_avis-eng.pdf