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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

FOR COMPENSATION 2.1 Definitions The following definitions apply to the definitions included in this document. “ADA” means the Disability Accessibility Standards of the Canadian Mental Health Association. “EACH AEROPHOBIA” means a wheelchair or another seating device which is an adjustable unit (i.e. can be adjusted by means of a hydraulic or pneumatic apparatus) which is capable of supporting an individual who is wheelchair bound, or otherwise requires a different seating position than that provided to a person who would otherwise use the wheelchair.(emphasis added) “EACH ANTITHETICALLY PREVENTED AEROPHOBIA” means a wheelchair or another seating device which is an adjustable unit (i.e. can be adjusted by means of a hydraulic or pneumatic apparatus) which is capable of supporting an individual who is wheelchair bound, or otherwise requires a different seating position than that provided to a person who would otherwise use the wheelchair.(emphasis added) 'EACH AMBULATION AIDS CATEGORY DEVICE” means a device which is specifically designed to assist individuals with AIDS and other infectious diseases. A device is considered to be specifically designed to assist individuals with AIDS and other infectious diseases if the device:(2) has an assistive function of a type which is significantly different from the function of a seating aid, mobility aid, walker, crutch or other assistance device intended for a person with an identifiable disability; and(3) is compatible with, or compatible with an assistive device, such as a wheelchair or other seating device. “AEROPHOBIA” means any disease, disorder, or pathological condition in a person, whether such disease, disorder, or pathological condition results in the inability to walk normally, and which is manifested by:(4) impairment of the function of the respiratory, circulatory, or neurological systems;(5) limitation of the functions of the muscles, bones or joints; or(6) impairment of normal tissue function, including, but not limited to, loss of hair, loss of fingernails and fingerprints, and loss of teeth.

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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.

When is the deadline to file device listing application package in 2023?

The deadline to file the device listing application package in 2023 may vary depending on the regulatory requirements of the specific jurisdiction. It is recommended to refer to the guidelines provided by the regulatory authority for the accurate deadline.

What is the penalty for the late filing of device listing application package?

The penalty for the late filing of a device listing application package can vary depending on the regulatory requirements of the specific jurisdiction. It is advisable to consult the regulatory authority or legal counsel for information regarding the specific penalties and consequences.

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