Regulatory Open Forum

Hello,

We were audited by Health Canada (remotely) and they requested that we get a confirmation of our device classification from Medical Device Bureau (MDB). Which we did, however the officer from HC seems to think our devices are Class-II instead of Class-I. We went back and forth with them but the officer, does not seem to agree with the classification route we took. Clearly, we are in disagreement. Can anyone guide me on how to approach this and how to formally ask Health Canada for reconsideration.

Thanks,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
United States
------------------------------

The only meeting type that Health Canada offers is their Pre-Submission - which is more a pre-clinical meeting about clinical investigations - not about other subjects.  Plus this is only a pilot at the moment ending this month, so not sure what will happen to this program in the future.

With that said, Health Canada is fairly friendly and open, so would ask them if you could have a (in)formal teleconference to discuss the issues.  Just like other agencies, I would make this request in writing, clearly describe the issue, explain your position, have good justification why your device is a Class I and not a Class II, outline your reasoning and justification according to the Rule classification.  Then politely request a teleconference to review the information.

Also note that Health Canada leverages the classification process similar to the European Union, so with the publication of the Medical Device Regulation they (Health Canada) have already published notification that some devices are re-classified ... or was that Australia, sorry think that was Australia.  Regardless, I can imagine that Health Canada are applying similar regulatory position seen in the Medical Device Regulation, so are you sure that maybe your Class I device is not really a Class II now?  Also Health Canada has a Product Code listing that loosely matches to FDA, what classification is the device in the United States?

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 12-Mar-2019 19:13
From: Sheemah Kazi
Subject: Health Canada- Classification Differences

Hello,

We were audited by Health Canada (remotely) and they requested that we get a confirmation of our device classification from Medical Device Bureau (MDB). Which we did, however the officer from HC seems to think our devices are Class-II instead of Class-I. We went back and forth with them but the officer, does not seem to agree with the classification route we took. Clearly, we are in disagreement. Can anyone guide me on how to approach this and how to formally ask Health Canada for reconsideration.

Thanks,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
United States
------------------------------

Hi Richard,

Thank you so much for your response.
Our devices are class I with measuring function in EU. I am certain that our devices are not class II now. I repeatedly asked the officer for teleconference so that we can discuss this issue. She did not agree to it, until this morning. Which is a great news for us. I will definitely take a closer look at the keyword index you mentioned. 

Thanks,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
Concord CA
United States
------------------------------

Original Message:
Sent: 13-Mar-2019 06:26
From: Richard Vincins
Subject: Health Canada- Classification Differences

The only meeting type that Health Canada offers is their Pre-Submission - which is more a pre-clinical meeting about clinical investigations - not about other subjects.  Plus this is only a pilot at the moment ending this month, so not sure what will happen to this program in the future.

With that said, Health Canada is fairly friendly and open, so would ask them if you could have a (in)formal teleconference to discuss the issues.  Just like other agencies, I would make this request in writing, clearly describe the issue, explain your position, have good justification why your device is a Class I and not a Class II, outline your reasoning and justification according to the Rule classification.  Then politely request a teleconference to review the information.

Also note that Health Canada leverages the classification process similar to the European Union, so with the publication of the Medical Device Regulation they (Health Canada) have already published notification that some devices are re-classified ... or was that Australia, sorry think that was Australia.  Regardless, I can imagine that Health Canada are applying similar regulatory position seen in the Medical Device Regulation, so are you sure that maybe your Class I device is not really a Class II now?  Also Health Canada has a Product Code listing that loosely matches to FDA, what classification is the device in the United States?

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 12-Mar-2019 19:13
From: Sheemah Kazi
Subject: Health Canada- Classification Differences

Hello,

We were audited by Health Canada (remotely) and they requested that we get a confirmation of our device classification from Medical Device Bureau (MDB). Which we did, however the officer from HC seems to think our devices are Class-II instead of Class-I. We went back and forth with them but the officer, does not seem to agree with the classification route we took. Clearly, we are in disagreement. Can anyone guide me on how to approach this and how to formally ask Health Canada for reconsideration.

Thanks,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
United States
------------------------------

Richard has provided great advice!

Are there any predicates for this device marketed in Canada?  I would suggest searching the MDALL for any predicate devices that exist and see how they are classified.  If they are also Class I, this may help your case in your meeting with them, along with having clear justifications for classification rules 1-16.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
------------------------------

Original Message:
Sent: 12-Mar-2019 19:13
From: Sheemah Kazi
Subject: Health Canada- Classification Differences

Hello,

We were audited by Health Canada (remotely) and they requested that we get a confirmation of our device classification from Medical Device Bureau (MDB). Which we did, however the officer from HC seems to think our devices are Class-II instead of Class-I. We went back and forth with them but the officer, does not seem to agree with the classification route we took. Clearly, we are in disagreement. Can anyone guide me on how to approach this and how to formally ask Health Canada for reconsideration.

Thanks,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
United States
------------------------------

Thanks Brittany!
That is a wonderful idea.I will definitely look at MDALL for the predicate device classification.

Best,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
Concord CA
United States
------------------------------

Original Message:
Sent: 13-Mar-2019 12:49
From: Brittany Gibson
Subject: Health Canada- Classification Differences

Richard has provided great advice!

Are there any predicates for this device marketed in Canada?  I would suggest searching the MDALL for any predicate devices that exist and see how they are classified.  If they are also Class I, this may help your case in your meeting with them, along with having clear justifications for classification rules 1-16.

------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada

Original Message:
Sent: 12-Mar-2019 19:13
From: Sheemah Kazi
Subject: Health Canada- Classification Differences

Hello,

We were audited by Health Canada (remotely) and they requested that we get a confirmation of our device classification from Medical Device Bureau (MDB). Which we did, however the officer from HC seems to think our devices are Class-II instead of Class-I. We went back and forth with them but the officer, does not seem to agree with the classification route we took. Clearly, we are in disagreement. Can anyone guide me on how to approach this and how to formally ask Health Canada for reconsideration.

Thanks,
Sheemah

------------------------------
Sheemah Kazi
QA/RA coordinator
United States
------------------------------