DRAFT
Guidance for the Labelling of In Vitro Diagnostic Devices

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Therapeutic Products Programme
GUIDANCE DOCUMENT

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.

To: Medical Devices Stakeholders

Subject: Guidance for the Labelling 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 Labelling 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.

This guidance document is intended to assist manufacturers in understanding and complying with the regulatory requirements for labelling in vitro diagnostic devices.

For more information on in vitro diagnostic devices please contact:
Maria Carballo
Head, In Vitro Diagnostic Devices Section, Device Evaluation Division
phone: (613)-954-9391

To comment on this document or to get more information on how to label an IVDD please contact by July 15, 1998:

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.

Beth Pieterson
A/Director
Medical Devices Bureau

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