By Nick Otto
Beginning Dec. 1, 2014, Health Canada, the country’s medical device regulator, is going to require electronic submissions for many high-risk Class III and Class IV medical device license applications.
The new regulations require that device makers submit review documents using one of three formatting options, according to recent guidance posted to the Health Canada’s website. Those formatting options include:
- Health Canada’s guidance on supporting evidence
- Summary Technical Documentation
- International Medical Devices Regulators Forum Table of Contents documents – according to the upcoming implementation pilot
Health Canada requests that device makers organize the contents of their submissions in folders, and the agency noted that it prefers submissions be in portable document formats (PDF). However, Health Canada said Microsoft Office formats such as .doc and .pptx may be accepted.
Health Canada suggests that submissions including bookmarks should be equivalent to, and organized like, a table of contents, and documents made up of 10 pages or more should be bookmarked as a group. Additionally, a bookmark should be used for different sections, subsections, tables, figures, and appendices.
“The new electronic filing requirements guidance does not apply to Class II MDL applications, faxback amendments or investigational testing authorizations,” according to the Emergo Group, a medical device consulting group. The organization added that Health Canada said it plans to issue a separate guidance to address these specific types of documents.
Health Canada asks device makers when naming the files to keep them brief and to not exceed 200 characters in name. It adds that use of abbreviations in the file names will be allowed to help shorten file names.
Additionally, according to the guidance, device makers should condense all documents in as few CDs or DVDs as possible. Discs must also include the following information:
- Manufacturer’s name
- Device name
- Application Number and/or License Number, if known;
- “Protected B,” which indicates that unauthorized disclosure of information could cause a medium degree of potential injury
- Virus free certification, the software used for the virus check and the date of the virus definition file(s)
- Date of submission
- Disc number and total number of discs (for example, Disc 1 of 2)
According to Health Canada, the notice applies to “any subsequent documents submitted in support of the applications, including responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters.”
The agency notes that paper-based submissions, while in the correct and established format, will still be accepted. However, Health Canada still encourages industry to submit documents in an electronic format. Also, the agency noted that current submissions after the December start date may freely switch to electronic-only responses if so desired.