DRAFT Guidance for the Risk-based Classification System

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Contact: Device Licensing

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Therapeutic Products Programme
GUIDANCE DOCUMENT

Date Prepared / Draft Number May 4, 1998 (md_risk5.wpd)
Supersedes April 8, 1998
Date Approved by Responsible Authority
Date Transmitted for External Consultation
Document Number GD006/RevDR-MDB

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

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Therapeutic Products Directorate

OUR MISSION: To ensure that the drugs, medical devices, and other therapeutic products available in Canada are safe, effective and of high quality.

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May 4, 1998

To: Medical Devices Stakeholders

Subject: Guidance for the risk based classification system (Draft)

The proposed 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, effective, and meet quality standards. It is the intention of the Therapeutic Products Programme to have these proposed Regulations published in Canada Gazette II in May 1998 and begin implementation on July 1, 1998.

This draft document, titled Guidance for the risk based classification system, sets out the Programme's guidance for Industry on the subject. It is being provided now in a draft format so that interested stakeholders can comment and participate in its development.

The goal of this document is to help manufacturers, importers and distributors understand the risk based classification system for medical devices other than in vitro diagnostic devices as described in Part I of Schedule I of the Medical Devices Regulations and to provide guidance on how to classify their devices.

To comment or to get more information on the risk based classification system for medical devices other than in vitro diagnostic devices please contact by May 15, 1998 the following:

Elizabeth Innes, PhD
Medical Devices Bureau
1605 Main Statistics Canada Building,
Postal Locator: 0301H1
Tunney's Pasture, Ottawa, Ontario K1A 0L2
phone: (613) 952-2623 fax: (613) 957-7318
email: elizabeth_innes@hc-sc.gc.ca

Thank you for providing your comments.
original signed by
Beth Pieterson
A/Director
Medical Devices Bureau

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