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November 10, 2014
Our file number: 14-112992-741
As part of the Health Products and Food Branch's ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, Health Canada is pleased to announce that Class III and IV medical device licence applications will now be accepted in electronic-only format if they meet the requirements of this notice, effective immediately.
Effective December 1, 2014, paper-based applications must also be structured in one of the formats described in this document in order to be accepted. These requirements are being made pursuant to section 32 of the Medical Devices Regulations, which allows the Minister to establish a format for applications. The acceptance of electronic-only submissions is another step in Health Canada's long-term goal of accepting fully electronic applications structured in an international standard and submitted through a secure gateway. Please note that a paper copy of the application form must also be included with each electronic submission. Submission of a paper application form is a temporary measure while we transition to a fully electronic submission process.
This document supersedes the October 19, 2011, notice titled Notice - Guidance for Industry: Preparation of a Premarket Review Document in Electronic Format for a Class III and 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 Class III and Class IV medical device licence applications. It defines the electronic file requirements and provides guidance on the format, structure, and content of electronic information and is intended to be read in conjunction with the following documents:
In addition to new and amendment licence applications, this notice 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. Submissions that are paper-based, when in the established format, will continue to be accepted but applicants are encouraged to submit in electronic format. Submissions that are already in progress after the effective date may switch to electronic-only responses.
Class II medical device licence applications, faxback amendments, and Investigational Testing Authorization (ITA) applications do not fall within the scope of this document and will be addressed in a separate 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.
Class III and Class IV applications must be submitted using one of the following formats:
Health Canada is a member of the International Medical Devices Regulators Forum (IMDRF), which is currently confirming that the Health Level Seven Regulated Product Submission (RPS) is a suitable international electronic message standard for medical device applications. The ToCs, which were designed for eventual use in an electronic submission environment, define the location and format of both common (IMDRF) and regional content for all submission types. The ToCs are available on the IMDRF website. Upon completion of the implementation pilot, Health Canada will be publishing a separate guidance document explaining the ToCs for Canadian-specific applications with the long-term goal of adopting this format as the required electronic format. Manufacturers will be contacted by e-mail in the coming months and will be asked to signal their interest in participating in the ToC implementation pilot.
The contents of an electronic submission are to be organized in folders. The figures in Appendix 1 provide an overview of the folder structure that applicants are to follow for premarket review document submissions for Class III and Class IV applications. Table 1 of the appendix is to be used to determine the correct structure based on the class of the device and the desired format. The folders must be named exactly as shown in the figures. Please see Appendix 2 for a list of abbreviations used in the folder names.
Folders of the initial application are not to be deleted if they are not applicable. Rather, they must contain a PDF document with the statement "This Section is not Applicable".
Applicants wishing to submit using the RPS ToC should consult the forthcoming guidance.
Submissions, both paper and electronic, that do not meet these structural requirements will be destroyed and the applicant required to resubmit in one of the accepted formats. If a revised application is not received, a Rejection Letter-Administrative Processing will be issued but no fees will be levied.
Portable document format (PDF) files are the preferred format for Health Canada electronic submissions although other formats such as Microsoft OfficeTM (.docx, .pptx, .xlsx) will be accepted if appropriate. Files submitted electronically are not to be password protected.
Portable Document Format (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:
Hyperlinks within the same PDF document are acceptable but links between different documents are not to be used. It is the manufacturer's responsibility to ensure that hyperlinks are functioning. Links must also include references to the specific section or page in the event the link is broken.
The naming convention for files is up to the applicant however the file names must be kept as brief and meaningful as possible. The entire file path must not exceed 200 characters and abbreviations may be used to shorten file names.
Each folder is to contain a file pertaining to that particular section. If the section is not applicable, the folder is to contain a PDF file with the text "This section is not applicable". For guidance on the content of a Class III and Class IV medical device premarket review document, please refer to the documents listed in the first page of this guidance. Supplemental information is also provided in the following device specific premarket guidance documents:
Manufacturers submitting any subsequent information must clearly identify the Application Number of the relevant application. Responses to Screening Deficiency Letters, Clarification Requests, and Additional Information Letters must be provided in a question and answer format and be accompanied by a copy of the original Health Canada letter. This information is to be filed under section 1.0 Cover Letter and the supporting information must be structured using the same format as the initial application. In this case, however, non-applicable folders may be deleted.
Applicants that choose to structure their electronic submissions in the STED format should refer to the existing guidance documents for content information.
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 are to be labelled with the following information:
Subsequent to burning the CD/DVD, please ensure that all files can be opened and that they are not corrupted.
Please direct any questions or comments regarding the content of this notice to the following:
Device Licensing Services Division
Medical Devices Bureau
2934 Baseline Road, Tower B
Postal Locator: 3403A
|Class III||Class IV|
|Non-IVDD||Health Canada: Figure 1
STED: Figure 4
|Health Canada: Figure 2
STED: Figure 5
|IVDD||Health Canada: Figure 3
STED: Figure 6
|Health Canada: Figure 3
STED: Figure 7
"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 http://www.tbs-sct.gc.ca/pol/doc-eng.aspx?id=12322§ion=text#sec10.6