Hi Heather,
In describing your product, you called it a System which is one of Health Canada's defined licence application types. There's a Health Canada
guidance that explains how to classify components/accessories depending on your application type.
A SYSTEM refers to a MEDICAL DEVICE, including an in vitro diagnostic device, that is sold under a single name and contains a number of COMPONENTS intended to be used together to fulfil some or all of the device's intended functions. COMPONENTS not sold under the SYSTEM name cannot be licensed with the SYSTEM, even when they are intended to be used together.
All the components of the SYSTEM that are produced by the MANUFACTURER of the SYSTEM are deemed licensed when the SYSTEM is licensed. COMPONENTS of the SYSTEM that are made by another MANUFACTURER must be licensed separately. All the COMPONENTS of a SYSTEM must be listed on the licence application by MEDICAL DEVICE NAME and IDENTIFIERS. The application must provide documentation and information on all COMPONENTS of a SYSTEM.
So, if your O-ring is a named component of your System licence, then it will take on the classification of your System.
If it is not made by the same manufacturer, or is sold under a different name, then it's not part of the System and should be licensed as a single medical device with its own
classification.
I hope that helps,
Karen
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Karen Long RAC
Vancouver BC
Canada
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Original Message:
Sent: 04-May-2018 00:52
From: Heather Neely
Subject: Health Canada- Class I Devices and Replacement Parts for Class II Regulators
Health Canada makes it clear that Class I devices don't need a medical device license (MDL), but they do need to be listed on the Medical Device Establishment License (MDEL). Does the device identifier for each Class I device have to be listed on the MDEL? In searching the MDALL, the answer appears to be yes.
We have a MDL for a Class II gas regulator that is part of a Class II system. The regulator requires replacement o-rings. Do the replacement o-rings take on the same class as the regulator (i.e. Class II) or are the replacement o-rings considered Class I?