DRAFT
Guidance For The Risk Based Classification System of In Vitro Diagnostic Devices

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Therapeutic Products Programme
GUIDANCE DOCUMENT

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

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.

April 24, 1998

To: Medical Devices Stakeholders

Subject: Guidance for the risk based classification system of in vitro diagnostic devices (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 of in vitro diagnostic devices, 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. Section numbers of the final CGII published version may differ from the Section numbers referenced in this draft document. This will be corrected in the final version of all guidance documents.

The goal of this document is to help manufacturers, importers and distributors understand the risk-based classification system for in vitro diagnostic devices described in Part II 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 in vitro diagnostic devices please contact by May 15, 1998 the following:

Maria Carballo
Device Evaluation Division, Medical Devices Bureau
1605 Main Statistics Canada Building,
Postal Locator: 0301H1
Tunney's Pasture, Ottawa, Ontario K1A 0L2
phone: (613) 954-9391, fax: (613) 946-8798
e-mail: maria_carballo@hc-sc.gc.ca

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

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