PDF《NOTICE》

Effective Date: 2006/09/01

2 2.2 Electronic Format of the Medical Device Keyword Index The electronic version of the Medical Device Keyword Index is presented in 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. It 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). 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

3 Keyword Preferred Name Code (PNC) Class Descripti........