Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a number of critical factors/variables. Those critical factors/variables include, but may not be limited to, the licence/device class, licence type, and the specifics of the change. Those details need to be known in order to unravel and apply Health Canada's corresponding licence amendment requirements.
Some changes can be made via relatively abbreviated amendments using an abbreviated mechanism/format offered by Health Canada, while other amendments need a full amendment using Health Canada's full amendment format, while still other changes will indeed demand a whole new licence application altogether. These amendment variables aren't driven by the manner in which you keep your internal technical documentation or file; instead, they are driven by the nature of the variables themselves.
Also of note, when doing applications for new or amended Canadian Medical Device Licences, we don't "designate" the applications via a cover letter; instead, we must choose and select the appropriate application type and Health Canada format corresponding to the nature of the change. Indeed, the application type and format are what intrinsically identify the type of application. In other words, if an applicant is planning on just using a cover letter and the applicant's own format for the Canadian licence application rather than the proper corresponding format(s) established by Health Canada, then the application will be rejected.
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Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 09-Mar-2023 06:33
From: Anonymous Member
Subject: Health Canada - Medical Device (Amendment?) License?
This message was posted by a user wishing to remain anonymous
Hi,
Greetings of the day!
We are presently working on a medical device licence (MDL) application for a product whose prior iteration received Canadian approval five years ago. While the new version is slightly different to HC approved device (amended version), there is a new set of technical documents available to compile the MDL technical file.
For the new MDL application, we are considering developing a new technical file, and the Cover letter specifically refers to the prior device HC licences. Should we designate this application as a "Medical device amendment" in this case, or should we refer to it as a "new application" as a new technical file is being planned?
Appreciate your view on this.