Medical Device Accessory - Health Canada guidance / definition on what an accessory is

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QAQT

Registered
#2
SOR/98-282 has only three instances of the the word "accessories", and those are as follows:
-In Schedule 1 (Classification Rules) Rule 3 states that despite rules 1 and 2 all denture materials and orthodontic appliances, and their accessories, are classified as Class II
-In Section 1 under the definition of "significant change" (c) the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories
-In Section 60 (2) The preliminary report shall contain the following information:
(f) the identity of any other medical devices or accessories involved in the incident, if known;

I am personally unaware of a specific definition for an accessory called out SOR/98-282 but look forward to seeing what other members are able to bring to this discussion.
 

shimonv

Trusted Information Resource
#3
Hi Laudie3,
I am not aware of a straight-forward HC definition of accessory, but this might help.
HC guidance on Guidance on the Risk-based Classification has a definition of a medical device that includes an "accessory":

"DEVICE (Food and Drugs Act) - means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in
(a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,
(b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,
(c) diagnosing pregnancy in human beings or animals,
(d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or
(e) preventing conception in human beings or animals;"

HC guidance on Classification of Products at the (Medical) Device-Drug Interface says this about accessory:

"A product considered to be an accessory to a device may itself be classified as a device under the “device” definition. A device accessory is distinguished by its intended purpose/associated claim(s) to enable or support the intended use of the primary device. For example, a gel used as a lubricant to assist in the insertion and use of a probe would be considered a device accessory. Moreover, a liquid solution intended to disinfect or sterilize a medical device could also be considered an accessory to that device."

The HC perception of accessory seems similar to that of the European MDR:
"accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)"

Shimon
 

RA Guy

Involved In Discussions
#4
Please note that Health Canada is generally supportive of using FDA guidance when something is not covered under existing Canadian guidance:
Notice: Use of United States Food and Drug Administration (FDA) Guidance Materials to support Canadian Medical Devices Licence Applications - Canada.ca

It is possible to use the existing FDA accessory guidance to inform your views, rationalize decisions and/or underpin proposals to Health Canada as long as it does not conflict with anything in the Act, Regulations or existing guidance.

As always, I strongly encourage direct communication with HC reps. Compared to FDA, these interactions tend to be less formal and guarded and Canadian reviewers are quite open about what approaches they've seen in terms of precedence or internal policies.
 
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