ARCHIVED - Notice - Consultation on five Medical Device Forms

Notice to the reader:

The online consultation is now closed.

Our file number: 15-108558-691
July 24, 2015

Health Canada is pleased to announce the release of the following five draft forms for a 60-day comment period.

  1. Draft New Class III Medical Device Licence Application Form
  2. Draft New Class IV Medical Device Licence Application Form
  3. Draft Class III Medical Device Licence Amendment Application Form
  4. Draft Class IV Medical Device Licence Amendment Application Form
  5. Draft Declaration of Conformity Form

The following changes apply to:

The Declaration of Conformity form has been completely revised. The revisions will help to clarify the intention of the form and make is more useful during the application review process. This includes additional space provided for manufacturers to provide important information on standards that are not recognized, but are considered by the manufacturer to be "equivalent or better".

Comments on these draft documents should be submitted by September 22, 2015 to the contact below:

Device Licensing Services Division
Medical Devices Bureau
Health Canada
2934 Baseline Road, Tower B
Postal Locator: 3403A
Ottawa, ON
K1A 0K9

Telephone: 613-957-7285
Facsimile: 613-957-6345
E-mail: devicelicensing-homologationinstruments@hc-sc.gc.ca

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2015-07-24