Guidance for Industry- Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices

September 12, 2006
Our file number: 06-120629-368

Notice

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 portable document format (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
2934 Baseline Road, Tower B
Address Locator: 3403A
Ottawa, Ontario K1A 0K9

Phone: (613) 957-7285
E-mail: devicelicensing-homologationinstruments@hc-sc.gc.ca

Document Change Log

File Name
keyword_motscles2_e.doc

Replaces
keyword_motscles_e.doc

Version
V3

Replaces
V2

Date
September 1, 2006

Replaces
January 14, 2000

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 guidance 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 United States Food and Drug Administration as much as is feasible.

• 73 - Anaesthesiology
• 74 - Cardiovascular
• 76 - Dental
• 77 - Ear, Nose and Throat
• 77 - Ear, Nose and Throat
• 79 - General and Plastic Surgery
• 80 - General Hospital and Personal Use
• 84 - Neurology
• 84 - Neurology
• 85 - Obstetrics and Gynaecology
• 86 - Ophthalmology
• 87 - Orthopaedics
• 89 - Physical Medicine
• 90 - Radiology

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).

Description is a string of two or more words that defines a medical device group.

2.2 Electronic Format of the Medical Device Keyword Index

The electronic version of the Medical Device Keyword Index is presented in portable document format (PDF) format.

2.3 How to Use the Medical Device Keyword Index

Instructions

1. Copy the Medical Device Keyword Index PDF file to your computer.
2. To search for a medical device group within the PDF file, go to Edit/Find.
3. Enter the keyword, PNC or description you are searching for in the "Find" field.

It must be noted that the class assigned to a medical device group/PNC is only indicative of the risk level of the majority of products that fall under this medical device group/PNC. It is not an exact determination. t is the responsibility of the manufacturer to use the Classification Rules for Medical Devices set out in the Medical Devices Regulations to determine the class of a specific device.

Examples

1. The majority of tracheostomy tubes (PNC 73EQK) are Class II medical devices by Rule 2(1) of the Medical Devices Regulations. However, if the manufacturer claims that the device is intended to remain in the body for longer than 30 consecutive days, it becomes a Class III device by Rule 2(3).
2. The majority of sinus trephines (PNC 77KBF) are surgical instruments as defined in the Medical Devices Regulations and are, therefore, Class I medical devices by Rule 3(b). However, if the device is disposable and/or is connected to an active device, it becomes a Class II device by Rule 1(1).