Regulatory Open Forum

We are studying what we need to do to sell our FDA class I medical device (IVDD) to Canada.  We already obtained CFG for other country, so it will not be an issue to obtain more for Canada.  The manufacturing process is European ISO-13485 certified, but not the CAN/CSA-ISO 13485.  Another thing is the intended use of our IVDD through FDA is that: our IVDD is to identify inorganic or organic compounds in human specimens by -----.  Since the intended use says about the human specimens, does it go to class II rather than class I in Canada even if this is a general IVDD?
So the questions are about the IVDD classification in Canada and CAN/CSA-ISO 13485 vs. European ISO-13485.  Please someone help me and point the regulations, where I can find see the specific guidance or regulations.

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Izumi 
United States
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Although I am not qualified to comment about the classification, I can point you to the single best document to clarify the differences for Canadian expectations related to ISO 13485.  This is the Health Canada Guidance Document GD210, "ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars."

Bill

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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 06-25-2015 13:34
From: Izumi Ishii-Clifford
Subject: FDA class I medical device to sell in CANADA

We are studying what we need to do to sell our FDA class I medical device (IVDD) to Canada.  We already obtained CFG for other country, so it will not be an issue to obtain more for Canada.  The manufacturing process is European ISO-13485 certified, but not the CAN/CSA-ISO 13485.  Another thing is the intended use of our IVDD through FDA is that: our IVDD is to identify inorganic or organic compounds in human specimens by -----.  Since the intended use says about the human specimens, does it go to class II rather than class I in Canada even if this is a general IVDD?
So the questions are about the IVDD classification in Canada and CAN/CSA-ISO 13485 vs. European ISO-13485.  Please someone help me and point the regulations, where I can find see the specific guidance or regulations.

-------------------------------------------
Izumi 
United States
-------------------------------------------

Hi Izumi,

Although you have the US classification for the product, you still need to consider the regulations and classification rules for each market in which you intend to commercialize your product.  Have a look at the Canadian medical device classification rules: http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-23.html.  Classification rules for IVDDs are in part 2.

After you determine whether or not your device is also considered to be class I in Canada, you can determine next steps.  Regardless of product registration, you will require establishment registration.

Emergo provides a good summary - refer to http://www.emergogroup.com/services/canada/canada-device-license and http://www.emergogroup.com/services/canada/canada-ivd-registration.

Excerpts from this summary that may be of value to you:

• If you manufacture Class I medical devices or IVDs and plan on selling directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL).
• If you choose to sell through distributors in Canada, your distributor requires have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Hopefully these links give you some ideas on how to start the commercialization process!

-------------------------------------------
Elizabeth Goldstein
Auckland
New Zealand
-------------------------------------------


Original Message:
Sent: 06-25-2015 13:34
From: Izumi Ishii-Clifford
Subject: FDA class I medical device to sell in CANADA

We are studying what we need to do to sell our FDA class I medical device (IVDD) to Canada.  We already obtained CFG for other country, so it will not be an issue to obtain more for Canada.  The manufacturing process is European ISO-13485 certified, but not the CAN/CSA-ISO 13485.  Another thing is the intended use of our IVDD through FDA is that: our IVDD is to identify inorganic or organic compounds in human specimens by -----.  Since the intended use says about the human specimens, does it go to class II rather than class I in Canada even if this is a general IVDD?
So the questions are about the IVDD classification in Canada and CAN/CSA-ISO 13485 vs. European ISO-13485.  Please someone help me and point the regulations, where I can find see the specific guidance or regulations.

-------------------------------------------
Izumi 
United States
-------------------------------------------

Hi Izumi,

The people at Health Canada are actually very helpful.  I emailed them recently to get help classifying our IVDD and within a few days they were able to tell me the classification and how to proceed with registering the product. Our IVDD was a FDA Class I but was Class II in Canada. I recommend reaching out to them.

Best of luck,
Joy

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Joy Pelfrey
Director of RA/QA
Norman OK
United States
-------------------------------------------


Original Message:
Sent: 06-26-2015 05:27
From: Elizabeth Goldstein
Subject: FDA class I medical device to sell in CANADA

Hi Izumi,

Although you have the US classification for the product, you still need to consider the regulations and classification rules for each market in which you intend to commercialize your product.  Have a look at the Canadian medical device classification rules: http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-23.html.  Classification rules for IVDDs are in part 2.

After you determine whether or not your device is also considered to be class I in Canada, you can determine next steps.  Regardless of product registration, you will require establishment registration.

Emergo provides a good summary - refer to http://www.emergogroup.com/services/canada/canada-device-license and http://www.emergogroup.com/services/canada/canada-ivd-registration.

Excerpts from this summary that may be of value to you:

• If you manufacture Class I medical devices or IVDs and plan on selling directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL).
• If you choose to sell through distributors in Canada, your distributor requires have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Hopefully these links give you some ideas on how to start the commercialization process!

-------------------------------------------
Elizabeth Goldstein
Auckland
New Zealand
-------------------------------------------


Original Message:
Sent: 06-25-2015 13:34
From: Izumi Ishii-Clifford
Subject: FDA class I medical device to sell in CANADA

We are studying what we need to do to sell our FDA class I medical device (IVDD) to Canada.  We already obtained CFG for other country, so it will not be an issue to obtain more for Canada.  The manufacturing process is European ISO-13485 certified, but not the CAN/CSA-ISO 13485.  Another thing is the intended use of our IVDD through FDA is that: our IVDD is to identify inorganic or organic compounds in human specimens by -----.  Since the intended use says about the human specimens, does it go to class II rather than class I in Canada even if this is a general IVDD?
So the questions are about the IVDD classification in Canada and CAN/CSA-ISO 13485 vs. European ISO-13485.  Please someone help me and point the regulations, where I can find see the specific guidance or regulations.

-------------------------------------------
Izumi 
United States
-------------------------------------------

It means the following if I paraphrase the comments by Liz from device manufacturers' perspectives.  

No MDEL is required when the importation or sale of a medical device by a device manufacturer in the case of a class II, III or IV medical device.

*: MDEL refers to Medical Devcie Establishment License

MDEL is required when the importatation or sale of a medical device by a device manufacturer in the case of a class I.

No MDEL is required in the case of a Class I device if the manufacturer imports or distributes solely through a person who holds an establishment licence. See Canadian Medical Devices Regulations (CMDR) Part 1, Article 44.(1)-(2)

You may download CMDR in PDF at https://wp.me/P2EoXX-1Gu


Original Message:
Sent: 06-26-2015 05:27
From: Elizabeth Goldstein
Subject: FDA class I medical device to sell in CANADA

Hi Izumi,

Although you have the US classification for the product, you still need to consider the regulations and classification rules for each market in which you intend to commercialize your product.  Have a look at the Canadian medical device classification rules: http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-23.html.  Classification rules for IVDDs are in part 2.

After you determine whether or not your device is also considered to be class I in Canada, you can determine next steps.  Regardless of product registration, you will require establishment registration.

Emergo provides a good summary - refer to http://www.emergogroup.com/services/canada/canada-device-license and http://www.emergogroup.com/services/canada/canada-ivd-registration.

Excerpts from this summary that may be of value to you:

• If you manufacture Class I medical devices or IVDs and plan on selling directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL).
• If you choose to sell through distributors in Canada, your distributor requires have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Hopefully these links give you some ideas on how to start the commercialization process!

-------------------------------------------
Elizabeth Goldstein
Auckland
New Zealand
-------------------------------------------


Original Message:
Sent: 06-25-2015 13:34
From: Izumi Ishii-Clifford
Subject: FDA class I medical device to sell in CANADA

We are studying what we need to do to sell our FDA class I medical device (IVDD) to Canada.  We already obtained CFG for other country, so it will not be an issue to obtain more for Canada.  The manufacturing process is European ISO-13485 certified, but not the CAN/CSA-ISO 13485.  Another thing is the intended use of our IVDD through FDA is that: our IVDD is to identify inorganic or organic compounds in human specimens by -----.  Since the intended use says about the human specimens, does it go to class II rather than class I in Canada even if this is a general IVDD?
So the questions are about the IVDD classification in Canada and CAN/CSA-ISO 13485 vs. European ISO-13485.  Please someone help me and point the regulations, where I can find see the specific guidance or regulations.

-------------------------------------------
Izumi 
United States
-------------------------------------------