Medical Device Single Audit Program (MDSAP)


As of January 1, 2019, Health Canada requires all manufacturers of class II, III, and IV medical devices sold in Canada to follow the Medical Device Single Audit Program (MDSAP). 

SAC members have raised concerns regarding the impact of MDSAP on their patients and clients, including access to the Passy-Muir Speaking Valve. The Passy-Muir Valve is currently an unlicensed medical device in Canada.


Health Canada has suggested the following alternatives to the Passy-Muir Speaking Valve: 

Licence no.

Licence name

Device ID

Device name



Montgomery Speaking Valves


Montgomery Speaking Valves


Shiley Phonate Speaking Valve





Shiley Phonate Speaking Valve


Shiley Phonate Speaking Valve (With Oxygen Port)


TRACOE Phon Assist II Speaking Valves REF 655-S AND REF 655-T With Attachable Tracoe Humid Assist II REF 645




Tracoe Humid Assist II


Tracoe Phon Assist II Speaking Valves


(page 34 to 38)

Health Canada has a Special Access Program to allow for access to unlicensed medical devices (such as the Passy-Muir Valve) in specific circumstances. 

The Special Access Program considers requests from health care professionals for access to unlicensed medical devices for emergency use, or if conventional therapies have failed, are unavailable or are unsuitable. Although Health Canada may issue an authorization for a medical device through this program, a manufacturer is not obligated to sell this medical device for special access purposes. 

A special access application would need to outline the circumstances for which approved devices are unsuitable or unavailable. Each application is considered on a case-by-case basis, and a previous authorization does not necessarily mean that another authorization will be granted.


For additional information about the Special Access Program, please refer to Health Canada guidance:


SAC members and associates are encouraged to contact should they encounter difficulty accessing an unlicensed medical device through the Special Access Program.


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