Notice: Preparation of Medical Device Regulatory Activities in the -Non-eCTD Electronic-Only- Format
December 14, 2016
Our file number: 16-113218-293
Health Canada is pleased to announce the acceptance of Medical Device regulatory activities in “non-eCTD electronic-only” format. This Notice serves as a revision to the Notice - Guidance for Industry: Formatting of Class III and Class IV Licence Applications (Electronic and Paper Formats), published on November 10th, 2014.
Electronic documents will be uploaded onto the Health Canada viewing tool, where they will be immediately accessible to Health Canada staff involved in the review of the regulatory activities. This will contribute to effective record management and ensure authenticity, integrity, availability, traceability, and non-repudiation of the data.
Effective immediately the following regulatory activities will be accepted in “non-eCTD electronic-only” format:
- Licence Applications for Class II, III & IV
- Licence Amendments for Class II, III & IV
- Licence Amendment Fax-back Forms for Class II, III & IV
- Private Label Licence Applications for Class II, III & IV
- Private Label Licence Amendments for Class II, III & IV
Any transactions related to the above regulatory activity types will also be accepted in “non-eCTD electronic-only” format. These transactions include, however are not limited to, the following:
- Response to a Clarification Request
- Response to Additional Information
- Letter Response to Screening Deficiency Letter (SDL)
As of April 1st, 2017, Health Canada will no longer accept paper copies of the above indicated regulatory activities or their related transactions.
Refer to the Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format for detailed guidance on filing the above regulatory activities or transactions in the ‘non-eCTD electronic-only” format.
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