Notice - Release of Proposed GHTF Guidance

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Contact: Egan Cobbold

August 18, 2008

Our file number: 08-122702-193

Release of Proposed GHTF¹ Guidance: SG3(PD)N17R7: Quality management system - Medical devices - Guidance on the control of products and services obtained from suppliers

The above referenced proposed guidance was released by the GHTF Steering Committee for consultation and is being posted on the Health Canada Website² for information and comment.

Existing regulatory requirements require manufacturers to control products and services obtained from suppliers. These requirements call for the type and extent of controls to be established and documented within the organization's quality management system. Control could be defined and documented in the form of contractual arrangements, quality plans or other types of documents.

Therefore, when a medical device manufacturer chooses to utilize suppliers, the manufacturer should ensure control over any product or service obtained from such suppliers as defined within the quality management system (QMS).

This document provides guidance for medical device manufacturers on control of products and services obtained from suppliers.

Please note that proposed guidance documents are only made available in English until finalized by the GHTF. It is also important to note that amendments to proposed documents may occur as a result of regulatory consultations and subsequent deliberations within the GHTF.

All comments forwarded to Health Canada will be transmitted to the GHTF as is, with the disclaimer that they are provided for information and do not necessarily represent the views of Health Canada, except as specifically indicated in separate comments.

As appropriate, your organization may alternatively wish to provide comments to your affiliate association in Australia, Europe, Japan or the U.S. for their input directly to GHTF.

Comments provided to Health Canada should be submitted no later than 15 September 2008 in order to allow sufficient time for their assessment and subsequent transmission to the GHTF.

Comments should be directed to:

Egan Cobbold
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada

Room 1605
Statistics Canada Main Building
150 Tunney’s Pasture Driveway
AL 0301 H1
Ottawa ON Canada
K1A 0K9

Email: egan_cobbold@hc-sc.gc.ca
Phone: 613-952-8250
Fax: 613-946-6758

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¹Global Harmonization Task Force

²As a weblink to the proposed document on the GHTF Website (www.ghtf.org)