October 19, 2011

Notice

Our Iile number: 11-118930-690

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 manuIacturers
and regulatory correspondents to submit Class IV medical device licence applications in both
paper and electronic Iormats. As part oI the continuing transition to the acceptance oI 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 manuIacturers and regulatory correspondents in preparing a
premarket review document in an electronic Iormat Ior a Class III and Class IV medical device
licence application. It deIines the electronic Iile requirements and provides guidance on the
Iormat, structure, and content oI electronic inIormation 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 (http://www.hc-sc.gc.ca/dhp-mps/md-
im/applic-demande/guide-ld/prmkt2precomm2-eng.php). Please note that Sections 1.0 to 4.0 oI
the Iolder structure diIIer Irom the paper-based guidance due to reorganization, however, no new
content or Iorms are required.

EIIective November 1, 2011, the scope oI the electronic submission pilot program will cover
medical device licence applications and medical device licence amendment applications Ior both
Class III and Class IV in vitro diagnostic devices (IVDDs) and non-IVDDs (medical devices).
ThereIore, as oI November 1, 2011, all premarket review documents Ior Class III and Class IV
medical device licence applications and licence amendment applications will be expected to be
submitted in both paper and electronic Iormats and be structured and prepared using the
speciIications outlined in this notice. This will also apply to any subsequent documents
submitted in support oI the applications, including responses to Screening DeIiciency Letters,
ClariIication Requests, and Additional InIormation Letters.

Alternatively, premarket review documents Ior Class III and Class IV non-IVDDs (medical
devices) may be structured in accordance with Table 1 and Table 2, respectively, oI the
document entitled Guidance Document: Preparation of the Summary Technical Documentation
(STED)-based Class III and Class IV Premarket Medical Device Licence Applications
(http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/mddraItgdimebaucheldsted-
eng.php).
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The provision oI all sections oI the premarket review document in electronic Iormat beneIits both
Health Canada and manuIacturers. Electronic documents will be uploaded onto the Health
Canada viewing tool where they will be immediately accessible to all Health Canada staII
involved with the review oI 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 oI the data.

1. Electronic Data Format, Structure and Content

1.1 File Format

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

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

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

1.2 Naming of Files

The naming convention Ior Iiles is up to the applicant. However, Health Canada suggests that
Iile names be kept as brieI and meaningIul as possible. Files names should be limited to a
maximum oI 64 characters, including the Iile extension. Abbreviations may be used to shorten
Iile names.



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1.3 Structure of Folders and their Naming Convention

The contents oI an electronic submission should be organized in Iolders. Figures 1, 2 and 3
provide an overview oI the Iolder structure that applicants are expected to Iollow Ior premarket
review document submissions Ior Class III non-IVDDs (medical devices) and IVDDs, Class IV
non-IVDDs (medical devices), and Class IV IVDDs, respectively. The Iolders should be named
exactly as shown in the Iigures. No abbreviations should be used and no additional sub-Iolders
should be created other than the ones indicated in the Iigures.

Alternatively, premarket review documents Ior Class III and Class IV non-IVDDs (medical
devices) may be structured in accordance with Table 1 and Table 2, respectively, oI the
document entitled Guidance Document: Preparation of the Summary Technical Documentation
(STED)-based Class III and Class IV Premarket Medical Device Licence Applications
(http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/mddraItgdimebaucheldsted-
eng.php).

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






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




















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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 oI a Class III and Class IV medical device premarket review
document, please reIer to the document entitled Preparation of a Premarket Review Document
for Class III and Class IV Device Licence Applications (http://www.hc-sc.gc.ca/dhp-mps/md-
im/applic-demande/guide-ld/prmkt2precomm2-eng.php). Supplemental inIormation is also
provided in the Iollowing device speciIic premarket guidance documents:

x Device Licence Applications for Ultrasound Diagnostic Systems and Transducers
(http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-
ld/ultrasoundultrasons-eng.php);


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x Guidance Document on the Regulation of Medical Devices Manufactured From
or Incorporating Viable or Non-Viable Animal Tissue or their Derivative(s)
(http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/animtiss-
eng.php);
x Pre-Market Guidance on Bare Cardiovascular Stents (http://www.hc-
sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/stentsnues-eng.php);
x Preparation of a Premarket Review Document for Breast Implant and Tissue
Expander Device Licence Applications (http://www.hc-sc.gc.ca/dhp-mps/md-
im/applic-demande/guide-ld/breastimplmammaires-eng.php); and
x Guidance Document Medical Device Applications for Implantable Cardiac
Leads (http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-
ld/mdgdimldcardileadsondes-eng.php).

ManuIacturers submitting any subsequent inIormation should clearly identiIy the Application
Number oI the relevant application. Responses to Screening DeIiciency Letters, ClariIication
Requests, and Additional InIormation Letters should be provided in a question and answer
Iormat and be accompanied by a copy oI the original Health Canada letter. This inIormation
should be Iiled under section 1.0 Cover Letter. The supporting data, however, is to be provided
in the appropriate section(s)/subsection(s) oI 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 (http://www.hc-
sc.gc.ca/dhp-mps/consultation/md-im/mddraItgdimebaucheldsted-eng.php) should reIer
to this document Ior content inIormation.

1.5 Letter of Attestation for Electronic Copy Submission

A Letter oI Attestation should be provided on the manuIacturer`s letterhead conIirming that the
content oI the electronic submission is identical to that oI the paper-based submission. The
Letter oI Attestation should be signed and dated by the senior oIIicial oI the manuIacturer and be
Iiled under subsection 3.3 Letter oI Attestation Ior Electronic Copy Submission oI the paper-
based submission. A sample Letter oI Attestation is shown in Figure 4.









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Figure 4: Sample Letter of Attestation














2. Media for Submitting Electronic Data

The only Iormats supported and accepted at this time are compact discs-recordable (CD-R)
conIorming to the Joliet speciIication, and digital video discs-random access memory (DVD-
RAM) and DVDR/-R recorded in the Universal Disk Format (UDF) standard. Please contact
the Medical Devices Bureau, Health Canada Ior other Iormats that may be acceptable at the time
oI Iiling.

ManuIacturers should place all documents in as Iew CDs or DVDs as possible. Duplicate copies
oI the CDs/DVDs are not required. The discs should be labeled with the Iollowing inIormation:

x ManuIacturer`s name;
x Device name;
x Application Number and/or Licence Number, iI known;
x 'Protected B
1
;
x Virus Iree certiIication, the soItware used Ior the virus check and the date oI the
virus deIinition Iile(s);
x Date oI submission; and
x Disc number and total number oI discs (Ior example Disc 1 oI 2).

Subsequent to burning the CD/DVD, please ensure that all Iiles can be opened and that they are
not corrupted.
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1
' Protected status identiIies inIormation the unauthorized disclosure oI which could reasonably be
expected to cause injury to private interests. 'Protected B indicates a medium degree oI potential
injury. See Government Security Policy (February 2002), subsection '10.6 IdentiIication oI
Assets. This policy is available at www.tbs-sct.gc.ca/pubspol/gospubs/TBM12A/gsp-
psg1e.asp.
[Manufacturers Letterhead]


I, as a senior oIIicial oI the manuIacturer, [name of manufacturer], attest that the
inIormation contained in the electronic submission Ior [name of device] matches the
inIormation contained in the paper-based submission. No inIormation has been added,
removed or changed.


Name: Title:

Signature: Date:


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3. Further Information

Please direct any questions or comments regarding the content oI this notice to the Iollowing:

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-m ail: devicelicensinghc-sc.gc.ca