Marketed health products directorate post-market submission guidance

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1 – Heading Classifications and Content Examples

Not all folders are required for a given submission and the classification, conditions and examples of appropriate content are presented in the table below.

Legend

  • R = Required
  • CR = Conditionally Required
  • O = Optional
  • NR = Not Required

All Classes for IVD and non-IVD (I to IV) Post-Market Request and Additional Information Responses to Post-Market Requests

Chapter 1 – Regional Administrative
  Classification Condition Examples

CH1.01-Cover Letter

R

-

Cover Letter / Email response from manufacturer

CH1.03-List of Terms/Acronyms

O

-

List of terms or acronyms that are used in the transaction

CH1.05-Listing of Device(s)

CR

Required if submitting for Class I
Class II, III, IV to be included when applicable or requested

List of devices including trade/product names, catalogue/reference numbers

CH1.09-Pre-Submission Correspondence and  Previous Regulator Interactions

R

-

MHPD request letter or email

Chapter 2 – Submission Context
  Classification Condition Examples

CH2.4.3-History of Development

CR

If applicable to request

E.g. in cases where design changes are requested/implemented

CH2.6-Global Market History

CR

If applicable to request

-

CH2.6.1-Global Market History

CR

If applicable to request

Countries where device is licensed and date of licensing

CH2.6.2-Global Incident Reports and Recalls

CR

If applicable to request

Global and Canadian complaints, Incident reports and summaries,  Root cause analysis, Investigation Update / Report, Recall information

CH2.6.3-Sales, Incident and Recall Rates

CR

If applicable to request

Global and Canadian incident rate (including rates in relation to sales), Sales data

CH2.7-Other Submission Context Information

CR

When information is requested by the regulator (through guidance documents or other communication) but does not belong in any of the other headings of this Chapter.

Health Canada Requested Information (Post Market)
Incident issue analysis (trending analysis)

Clinical Evaluation Summary of device safety and effectiveness data including MAH sponsored, studies/clinical trials and published literature when requested by MHPD

Post-market device safety issue analysis and risk/benefit analysis documents
Listing or Description of previous risk mitigation measures implemented or planned to address the post-market issue.

Chapter 5 – Labelling and Promotional Material
  Classification Condition Examples

CH5.02-Product/Package Labels

CR

If applicable to request

Package label

CH5.03-Package Insert/Instructions for Use

CR

If applicable to request

Current Instructions for Use, Package insert, Directions for Use

CH5.04-e-labelling

CR

If applicable to request

-

CH5.05-Physician Labelling

CR

If applicable to request

Physician labelling, Physician educational material

CH5.06-Patient Labelling

CR

If applicable to request

Patient brochure, Patient consent form, Patient educational material

CH5.07-Technical/Operators Manual

CR

If applicable to request

Maintenance manual

CH5.08-Patient File Stickers/Cards and Implant Registration Cards

CR

If applicable to request

-

CH5.09-Product Brochures

CR

If applicable to request

-

CH5.10-Other Labelling and Promotional Material

CR

If applicable to request

Any other documents that come with the device

2 – Resources and Tools

2.1 – Tools

The following additional tool is available to aid in creating MHPD post-market submissions:

3 – Mailing Address

For filing process, physical media requirements and mailing address, refer to the main IMDRF ToC Implementation guidance.

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