What is the procedure to reclassify a Medical Device in Canada?
- Thread starter Sheemah
- Start date
shimonv
Trusted Information Resource
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".
https://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/gd_rbc_non_ivdd_lg_scr_autres_idiv-eng.php
(broken link removed)
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.
-Shimon
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".
https://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/gd_rbc_non_ivdd_lg_scr_autres_idiv-eng.php
(broken link removed)
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.
-Shimon
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?
Thanks,
Sheemah
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?
Thanks,
Sheemah
shimonv
Trusted Information Resource
Hi Cheetah,
Class I is self declaration. The only thing I can think off right now is to prepare a signed memo with a rationale for its classification and referencing the applicable guidances and law (https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/ )
Hope it helps,
Shimon
Class I is self declaration. The only thing I can think off right now is to prepare a signed memo with a rationale for its classification and referencing the applicable guidances and law (https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/ )
Hope it helps,
Shimon
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