PDF《NOTICE》

September 12,

2006 NOTICE Our file number: 06-120629-368 Re: Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices Health Canada is pleased to announce the release of the revised Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices.

This guidance document supersedes the January 14,

2000 version of the same document. The Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is intended to assist manufacturers in confirming the classification of medical device products after application of the Classification Rules for Medical Devices set out in Schedule

1 of the Medical Devices Regulations. This guidance document has been revised to reflect changes to the risk- based classification of particular medical device groups. Specifically, the following major changes have been made to the document: ? the reclassification of specific medical device groups;

? the removal of redundant information;

? the addition of medical device groups;

and ? the omission of product groups that do not fit the meaning of a medical device as defined in the Food and Drugs Act. To search for a medical device group within the Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices PDF file, go to Edit/Find and enter a keyword, preferred name code or description in the Find field. For instance, to verify the risk-based classification of dental burs, enter bur or drill in the Find field. Please note that this guidance document is provided only as a guide and that in the event of any discrepancy between this document and the Classification Rules for Medical Devices described in the Medical Devices Regulations, the latter shall prevail. Please direct any questions or comments regarding the content of this guidance document to the following: Device Licensing Services Division Medical Devices Bureau

150 Tunney'

s Pasture Driveway Main Statistics Canada Building, Room

1605 Postal Locator: 0301H1 Ottawa, Ontario K1A 0K9 Phone: (613) 957-7285 Fax: (613) 957-6345 E-mail: [email protected] GUIDANCE FOR INDUSTRY Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices Published by authority of the Minister of Health Date Adopted 2000/01/14 Revised Date 2006/09/01 Effective Date 2006/09/01 Health Products and Food Branch Our mission is to help the people of Canada maintain and improve their health. Health Canada HPFB'

s Mandate is to take an integrated approach to the management of the risks and benefits to health related to health products and food by: ? Minimizing health ris k factors to Canadians while maximizing the safety provided by the regulatory system for health products and food;

and ? Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. Health Products and Food Branch ? Minister of Public Works and Government Services Canada

2006 Available in Canada through Health Canada - Publications Brooke Claxton Building, A.L. #0913A Tunney'

s Pasture Ottawa, Ontario K1A 0K9 Tel: (613) 954-5995 Fax: (613) 941-5366 ?galement disponible en fran?ais sous le titre : Index de mots-clés pour aider les fabricants à vérifier la classification des matériels médicaux Health Canada Keyword Index to Assist Manufacturers in Guidance for Industry Verifying the Class of Medical Devices Revised Date: 2006/09/01;

Effective Date: 2006/09/01 i Document Change Log File Name keyword_motscles2_e.doc Replaces keyword_motscles_e.doc Version V3 Replaces V2 Date September 1,