Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Device Licence Applications

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DED Manager

Therapeutic Products Programme
GUIDANCE DOCUMENT

Date Prepared / Draft Number: February 25, 2001 (Version 3)

Supersedes: January 10, 2000 (Version 2)

Date Transmitted for Internal Consultation

Date Approved by Responsible Authority

Date Transmitted for External Consultation

Document Code/Revision Number: GD017/Rev00-MDB

Therapeutic Products Directorate
Medical Devices Bureau
Room 1605, Main Statistics Canada Building
Tunney's Pasture, P.L. 0301H1
Ottawa, Ontario
K1A 0L2

February 25, 2001

To: All Stakeholders:

To: Medical Devices Stakeholders

Subject: Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Applications

The Medical Devices Regulations set out the requirements governing the sale, importation and advertisement of medical devices. The goal of the Regulations is to ensure that medical devices distributed in Canada are safe and effective and meet quality standards. These Regulations were published in Canada Gazette II on 27 May 1998, and implementation began on 1 July 1998.

This document, entitled Preparation of a Premarket Review Document for Breast Implant and Tissue Expander Applications, sets out the Programme's guidance for Industry on the subject.

This guidance document is to be used in the preparation of Class IV medical device licence applications and licence amendment applications, in compliance with the licensing provisions in section 32 of the Medical Devices Regulations. Licence applications for breast implants and tissue expanders will require a scientific and medical review of submitted evidence of safety and effectiveness before their licence applications can be finalized.

For more information on how to prepare a premarket review document for breast implant or tissue expander device licence applications, please contact any of the following:

Roland Rotter, Ph.D., Interim Manager, Device Evaluation Division
phone: (613) 954-0297
email: Roland_Rotter@hc-sc.gc.ca

Manager, Device Evaluation Division
phone: (613) 954-0297
email: DED_Manager@hc-sc.gc.ca

Mary-Jane Bell, PhD, Head, Musculoskeletal Section
phone: (613) 954-0377
email: Mary-Jane_Bell @hc-sc.gc.ca

original Signed By:
Beth Pieterson
A/Director
Medical Devices Bureau

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