Notice: Publication of the Guidance Document: Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers

January 16, 2017
Our file number: 17-1003110-257

Health Canada is pleased to announce the publication of the guidance document – Preparation of Premarket Medical Device Licence and Licence Amendment Applications for Dermal Fillers. This guidance document provides details regarding the scientific and clinical content to be submitted in support of Class III and Class IV medical licence applications for dermal fillers.

The draft version of this guidance document was posted to the Health Canada website from August 27, 2015 until October 27, 2015 for a 60-day consultation. Stakeholder comments received on the draft version of these documents were considered in the finalization of this guidance document. In addition, a new statement was recently included in section 2.3.3 “Warnings and Precautions” to address recent post-market concerns regarding potential complications associated with intravascular injection.

All revisions to this guidance document are effective immediately.

Questions or concerns regarding this guidance document should be directed to:

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate Health Canada
11 Holland Avenue
Locator: 3002A
Ottawa, Ontario
K1A 0K9

E-mail: device_licensing@hc-sc.gc.ca
Telephone: 613-957-7285