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

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Contact: Device Licensing

October 19, 2011

Our file number: 11-118930-690

Notice

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

On January 1, 2010, Health Canada implemented a pilot program to encourage manufacturers and regulatory correspondents to submit Class IV medical device licence applications in both paper and electronic formats. As part of the continuing transition to the acceptance of stand-alone electronic submissions, Health Canada is extending this pilot program to include Class III medical device licence applications.

This notice is intended to assist manufacturers and regulatory correspondents in preparing a premarket review document in an electronic format for a Class III and 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 III and 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.

Effective November 1, 2011, the scope of the electronic submission pilot program will cover 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. This will also apply to any subsequent documents submitted in support of the applications, including responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters.

Alternatively, premarket review documents for Class III and Class IV non-IVDDs (medical devices) may be structured in accordance with Table 1 and Table 2, respectively, of the document entitled Guidance Document: Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications.

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.

1. Electronic Data Format, Structure and Content

1.1 File Format

Health Canada encourages applicants to submit documents for Class III and 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. Figures 1, 2 and 3 provide an overview of the folder structure that applicants are expected to follow for premarket review document submissions for Class III non-IVDDs (medical devices) and IVDDs, Class IV non-IVDDs (medical devices), and Class IV IVDDs, respectively. The folders should be named exactly as shown in the figures. No abbreviations should be used and no additional sub-folders should be created other than the ones indicated in the figures.

Alternatively, premarket review documents for Class III and Class IV non-IVDDs (medical devices) may be structured in accordance with Table 1 and Table 2, respectively, of the document entitled Guidance Document: Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications.

Figure 1: Electronic Folder Structure for a Premarket Review Document for a Class III Non-IVDD (Medical Device) and IVDD Licence Application

Figure 2: Electronic Folder Structure for a Premarket Review Document for a Class IV Non-IVDD (Medical Device) Licence Application

Figure 3: Electronic Folder Structure for a Premarket Review Document for a Class IV IVDD Licence Application

1.4 File Content

For guidance on the content of a Class III and 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; and
• Guidance Document - Medical Device Applications for Implantable Cardiac Leads.

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.

Applicants that choose to structure their electronic submissions as outlined in the document entitled Guidance Document: Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications should refer to this document for content information.

1.5 Letter of Attestation for Electronic Copy Submission

A Letter of Attestation should be provided on the manufacturer's letterhead confirming that the content of the electronic submission is identical to that of the paper-based submission. The Letter of Attestation should be signed and dated by the senior official of the manufacturer and be filed under subsection 3.3 Letter of Attestation for Electronic Copy Submission of the paper-based submission. A sample Letter of Attestation is shown in Figure 4.

Figure 4: Sample Letter of Attestation

2. Media for Submitting Electronic Data

The only formats supported and accepted at this time are compact discs-recordable (CD-R) conforming to the Joliet specification, and digital video discs-random access memory (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 CDs or 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"^{Footnote 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 (for example 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

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