PDF《NOTICE》

2006 Replaces January 14,

2000 Change Location Nature of Change

1 File Name File name has been changed from kwindxv2.wpd to kwindxv3.doc .

2 Entire Document Minor editorial and style changes have been made to the entire document.

3 Notice Letter Notice letter to all stakeholders has been added to the beginning of the document.

4 Title Page Content and style of title page revised.

5 2.3 How to Use the Medical Device Keyword Index An additional example has been provided.

6 Medical Device Keyword Index Following changes have been made to the Medical Device Keyword Index: ? the reclassification of specific medical device groups;

? the removal of redundant information;

? the addition of medical device groups;

? the omission of product groups that do not fit the meaning of a medical device as defined in the Food and Drugs Act;

and ? the clarification of medical device group descriptors. 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

1 1.0 PURPOSE The purpose of the Medical Device Keyword Index is to assist manufacturers in verifying 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. The Medical Device Keyword Index should also be used in conjunction with the guidan ce document titled Guidance for the Risk-based Classification System, GD006/RevDR-MDB . Please note that this 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. 2.0 MEDICAL DEVICE KEYWORD INDEX The Medical Device Keyword Index is an alphabetical listing of words which appear in the short descriptors for medical device groups identified by the Medical Devices Bureau. It contains synonyms and industry words that are commonly used to describe the products in these device groups. It consists of the following four fields: Keyword, Preferred Name Code (PNC), Class and Description. 2.1 Definitions Keyword means the words which appear in the short descriptors for medical device groups as well as synonyms and industry words that are commonly used to describe the products in these device groups. Preferred Name Code (PNC) is a five character alpha-numeric code (2 numeric and

3 alpha) which represents a medical device group. The three letters represent the specific medical device group and the two numbers represent the medical specialty in which it is routinely, but not necessarily exclusively, used. These codes are harmonized with the U.S. Food and Drug Administration as much as is feasible.

73 C Anaesthesiology

84 C Neurology

74 C Cardiovascular

85 C Obstetrics &

Gynaecology

76 C Dental

86 C Ophthalmology

77 C Ear, Nose &

Throat

87 C Orthopaedics

78 C Gastroenterology &

Urology

89 C Physical Medicine

79 C General &

Plastic Surgery

90 C Radiology

80 C General Hospital &

Personal Use Class is a number from

1 to 4, with

1 representing the lowest risk classification and

4 representing the highest risk classification. The class assigned to a medical device group by the Medical Devices Bureau represents the risk level of the majority of products that are currently in the database and assigned this medical device group code (PNC). Descriptionis a string of two or more words that defines a medical device group. Keyword Index to Assist Manufacturers in Health Canada Verifying the Class of Medical Devices Guidance for Industry Revised Date: 2006/09/01;