ARCHIVED - Notice - Consultation on five Medical Device Forms

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:

• Section 13:
  • Class III Medical Device Licence Application Form
• Section 14:
  • Application for a New Class III Medical Device Licence
  • Application for a New Class IV Medical Device Licence
  • Class IV Medical Device Licence Amendment Application Form

• This section has been reworded to allow for the choice of "Yes" where applicable. Manufacturers will no longer be restricted to choosing only one option.
• The space to list the relevant standards has also been removed from the application form since this information is already required on the Declaration of Conformity form.
• Item 1 - This section has been updated to indicate that the medical devices subject to this application conform with the Recognized Standards listed in the list of recognized standards for medical devices and that a Declaration of Conformity is included with the application.
• Item 2 - This section has been updated to indicate that a Declaration of Conformity form is included with the application attesting that the medical devices subject to this application DO NOT conform to Recognized Standards but comply with equivalent or better standards.

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