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WHEELCHAIR, POSITIONING AND AMBULATION AIDS CATEGORY DEVICE LISTING APPLICATION PACKAGE MANUFACTURERS & DISTRIBUTORS Assistive Devices Program Ministry of Health and Longer Care July 2009 2 Tables
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What is device listing application package?
The device listing application package is a collection of documents and forms required to register a medical device with the appropriate regulatory authority.
Who is required to file device listing application package?
Manufacturers, distributors, and importers of medical devices are required to file the device listing application package.
How to fill out device listing application package?
The device listing application package typically includes forms for providing general information about the company, detailed specifications of the device, manufacturing processes, and any applicable certifications or test reports. These forms can usually be filled out electronically or in paper format.
What is the purpose of device listing application package?
The purpose of the device listing application package is to provide regulatory authorities with information about a medical device, its manufacturer, and its intended use. This allows authorities to assess the safety and effectiveness of the device.
What information must be reported on device listing application package?
The device listing application package typically requires information such as the device name, model number, intended use, manufacturing facility details, and any relevant certifications or test reports. Additional information may be required depending on the regulatory requirements of the specific jurisdiction.
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