Notice - Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device Licence Application

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Contact: Device Licensing

December 14, 2009

Notice

Re: Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device Licence Application

This notice is intended to assist manufacturers and regulatory correspondents in preparing a premarket review document in an electronic format for a Class IV medical device licence application.  It defines the electronic file requirements and provides guidance on the format, structure, and content of electronic information to be included with a Class IV medical device licence application.  This notice is meant to be read in conjunction with the document entitled Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications published October 23, 1998. Please note that Sections 1.0 to 4.0 of the folder structure differ from the paper-based guidance due to reorganization, however no new content or forms are required.

The recommendation for submitting a premarket review document for a medical device licence application in both a paper and electronic format is part of Health Canada's transition to the acceptance of stand-alone electronic submissions.  As part of this transition, Health Canada is implementing an electronic submission pilot program for Class IV medical device licence applications.  As such, the scope of this notice only covers medical device licence applications and medical device licence amendment applications for Class IV in vitro and non-in vitro diagnostic devices (medical devices) filed pursuant to the Canadian Medical Devices Regulations.  Effective January 1, 2010, all Class IV medical device licence applications should be submitted in both a paper and electronic format and be prepared using the specifications outlined in this notice.

The provision of all sections of the premarket review document in electronic format benefits both Health Canada and manufacturers.  Electronic documents will be uploaded onto the Health Canada viewing tool where they will be immediately accessible to all Health Canada staff involved with the review of the submission.  Accessing the documents using the viewing tool will also contribute to good record management by ensuring authenticity, integrity, availability, traceability, and non-repudiation of the data.

Future revisions to this notice will be necessary as a result of the experience gained during implementation of the pilot program, expansion of the scope to include Class III medical device licence applications, and the adoption of the Summary Technical Documentation (STED) for medical device licence applications.

1. Electronic Data Format, Structure and Content

1.1 File Format

Health Canada encourages applicants to submit documents for Class IV medical device licence applications and amendment applications electronically as portable document format (PDF) files.  Files submitted electronically should not be zipped or password protected.

PDF versions of documents should be generated from electronic source documents and not from scanned materials, except where access to an electronic source document is unavailable or where a signature is required.  It is also important that PDF files be properly bookmarked.  The following are recommended as good bookmarking practices:

• Bookmarks are equivalent to and should be organized like a table of contents, and should not include the submission level.
• Documents of ten pages or more should be bookmarked.
• Sections, subsections, tables, figures and appendices should all be bookmarked.
• Too many levels of bookmarks are inefficient.  In most instances, three levels of bookmarks should be sufficient:
  1 Heading
  1.1 Subheading
  1.1.1 Sub-subheading.
• Health Canada recognizes that bookmarks are generated automatically from document headings, but, nevertheless, recommends that they be kept concise.

1.2 Naming of Files

The naming convention for files is up to the applicant. However, Health Canada suggests that file names be kept as brief and meaningful as possible. Files names should be limited to a maximum of 64 characters, including the file extension. Abbreviations may be used to shorten file names.

1.3 Structure of Folders and their Naming Convention

The contents of an electronic submission should be organized in folders.  Figure 1 and Figure 2 shows an example of a folder structure in which applicants are strongly recommended to follow for a premarket review document submission for a Class IV non-in vitro diagnostic device (medical device) and in vitro diagnostic device, respectively.  The folders should be named exactly as shown in Figure 1 and Figure 2.  No abbreviations should be used and no additional sub-folders should be created other than the ones indicated in Figure 1 and Figure 2.

Figure 1: Electronic Folder Structure for a Premarket Review Document for a Class IV Medical Device (Non-in vitro Diagnostic Device) Licence Application

Figure 2: Electronic Folder Structure for a Premarket Review Document for a Class IV in vitro Diagnostic Device Licence Application

1.4 File Content

For guidance on the content of a Class IV medical device premarket review document, please refer to the document entitled Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications. Supplemental information is also provided in the following device specific premarket guidance documents:

• Device Licence Applications for Ultrasound Diagnostic Systems and Transducers
• Guidance Document on the Regulation of Medical Devices Manufactured From or Incorporating Viable or Non-Viable Animal Tissue or their Derivative(s)
• Pre-Market Guidance on Bare Cardiovascular Stents
• Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Device Licence Applications

Manufacturers submitting any subsequent information should clearly identify the Application Number of the relevant application. Responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters should be provided in a question and answer format and be accompanied by a copy of the original Health Canada letter. This information should be filed under section 1.0 Cover Letter. The supporting data, however, is to be provided in the appropriate section(s)/subsection(s) of the submission.

Figure 3: Sample Letter of Attestation

[Manufacturer's Letterhead]

I, as a senior official of the manufacturer, [name of manufacturer], attest that the information contained in the electronic submission for [name of device] matches the information contained in the paper-based submission.  No information has been added, removed or changed.

Name:
Title:
Signature:
Date:

2. Media for Submitting Electronic Data

The only formats supported and accepted at this time are CD-R conforming to the Joliet specification, and DVD-RAM and DVD+R/-R recorded in the Universal Disk Format (UDF) standard. Please contact the Medical Devices Bureau, Health Canada for other formats that may be acceptable at the time of filing.

Manufacturers should place all documents in as few compact discs (CDs) or digital video discs (DVDs) as possible. Duplicate copies of the CDs/DVDs are not required. The discs should be labeled with the following information:

• Manufacturer's name;
• Device name;
• Application Number and/or Licence Number, if known;
• "Protected B"¹;
• Virus free certification, the software used for the virus check and the date of the virus definition file(s);
• Date of submission; and
• Disc number and total number of discs (e.g. Disc 1 of 2).

Subsequent to burning the CD/DVD, please ensure that all files can be opened and that they are not corrupted.

3. Further Information

Please direct any questions or comments regarding the content of this notice to the following:

• Device Licensing Services Division
• Medical Devices Bureau
• Health Canada
• 150 Tunney's Pasture Driveway
• Main Statistics Canada Building, Room 1605
• Postal Locator: 0301H1
• Ottawa, Ontario
• K1A 0K9

• Phone: 613-957-7285
• Fax: 613-957-6345
• E-mail: device_licensing@hc-sc.gc.ca

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¹ "Protected" status identifies information the unauthorized disclosure of which could reasonably be expected to cause injury to private interests.  "Protected B" indicates a medium degree of potential injury.  See Government Security Policy (February 2002), subsection "10.6 Identification of Assets".  This policy is available at www.tbs-sct.gc.ca/pubs_pol/gospubs/TBM_12A/gsp-psg1_e.asp.