What is the procedure to reclassify a Medical Device in Canada?


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Re: Reclassification of Device in Canada

Hi Sheemah,
You provided very little information to go on. In a nutshell, you should first review Health Canada's guidance on "Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)" and "Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices".



If you have a case you should contact them by mail of phone and ask how to proceed. I, personllay, am not aware of any formal guidance or policy on this subject.



Starting to get Involved
Hi Shimon,

Thank you for your reply.I have reviewed both the documents.According to Classification our devices are class-I and looking the notice Keyword index... , our devices are class-II , however, the notice has statement in saying that "in any discrepancy between this document and Medical Device Classification follow the latter". Hence , it justifies that our devices are class-I.
Our Customer in Canada are asking us to provide an offical document from Health Canada Specifying our devices names and stating they are class-I. They are not ready to accept just the MDEL license as the only official document.
I have reached out to Health Canada , in regards to this matter but they say we do not issue any such documents, what would be best route to prove that our devices are class-I?

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