Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications V.2

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Therapeutic Products Programme
GUIDANCE DOCUMENT

Date Prepared / Draft Number October 23, 1998 (prmkt2.wpd)
Supersedes April 17, 1998 (prmkt2.wpd)
Date Approved by Responsible Authority
Date Transmitted for External Consultation
Document Code/Revision Number GD008/Rev00-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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October 23, 1998

To: Medical Devices Stakeholders

Subject: Preparation of a Premarket Review Document for Class III and Class IV Device Licence 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 Class III and Class IV Device Licence Applications, sets out the Programme's guidance for Industry on the subject.

This guidance document is to be used in the preparation of Class III and Class IV medical device licence applications and licence amendment applications, in compliance with the licensing provisions in section 32 of the Medical Devices Regulations. All Class III and Class IV medical devices 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 Class III and Class IV device licence applications, please contact any of the following:

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

Mary-Jane Bell, PhD (devices in general)
phone: (613) 954-0377
email: Mary-Jane_Bell@hc-sc.gc.ca

Maria Carballo, Head, In-vitro Diagnostic Devices Section
phone: (613) 954-9391
email: maria_carballo@hc-sc.gc.ca

Address:
Device Evaluation Division, Medical Devices Bureau
1605 Statistics Canada Main Building
Postal Locator: 0301H1, Tunney's Pasture
Ottawa, Ontario K1A 0L2
Fax: (613) 946-8798

original signed by..

Beth Pieterson
A/Director
Medical Devices Bureau

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