Regulatory Open Forum

Hello,

I am looking into the requirements of selling a product in Canada legally. The device is a menstrual cup and in the US it is class II, 510(k) exempt, not GMP exempt, OTC (no prescription required). In Canada, as far as I can tell, it is class II and there aren't any special rules, exceptions or carve-outs. This leads me to think we would need a medical device establishment license, a medical device license, and a MDSAP audit cert for submission to Health Canada. Can anyone confirm if this is correct? I couldn't find anything from Health Canda that is equivalent to the US FDA GMP exempt, 510(k) exempt or OTC vs Rx rules. I contacted Health Canada and was directed to the standard rules for classification of devices. 

Thanks in advance.

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Erica Livingston
Carlsbad CA
United States
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Hi Erica

You will need to classify your device according to the guidance:  https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/guide-ld/gd_rbc_non_ivdd_lg_scr_autres_idiv-eng.pdf. 

Whether an establishment licence is required depends on the type of business activity. More info on establishment licensing in Canada:   https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html





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Karen Zhou
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Original Message:
Sent: 25-Jan-2022 16:16
From: Erica Livingston
Subject: Class IIa OTC medical device for sale in Canada

Hello,

I am looking into the requirements of selling a product in Canada legally. The device is a menstrual cup and in the US it is class II, 510(k) exempt, not GMP exempt, OTC (no prescription required). In Canada, as far as I can tell, it is class IIa and there aren't any special rules, exceptions or carve-outs. This leads me to think we would need a medical device establishment license, a medical device license, and a MDSAP audit cert for submission to Health Canada. Can anyone confirm if this is correct? I couldn't find anything from Health Canda that is equivalent to the US FDA GMP exempt, 510(k) exempt or OTC vs Rx rules. I contacted Health Canada and was directed to the standard rules for classification of devices.

Thanks in advance.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Menstrual Cups are generally, and have traditionally been, considered by Health Canada to be Class II medical devices (though your particular indications could change this in accordance with the CMDR's Schedule 1 risk-based classification rules).  Indeed, there are lots of menstrual cups currently licensed for Canada that are in Class II; so, that should give you some confidence in that baseline classification.

Note also that in Canada, the four device classes are only I, II, III, and IV; there is no class IIa for Canada.

In general, for a manufacturer, the Health Canada premarket requirements for a Canadian class II device are generally as you say but with the exception that the manufacturer's Device License generally exempts the manufacturer from needing an Establishment License for the same device.  But the establishment's other separate operations involving other devices may separately trigger the need for an Establishment License.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 25-Jan-2022 16:16
From: Erica Livingston
Subject: Class IIa OTC medical device for sale in Canada

Hello,

I am looking into the requirements of selling a product in Canada legally. The device is a menstrual cup and in the US it is class II, 510(k) exempt, not GMP exempt, OTC (no prescription required). In Canada, as far as I can tell, it is class IIa and there aren't any special rules, exceptions or carve-outs. This leads me to think we would need a medical device establishment license, a medical device license, and a MDSAP audit cert for submission to Health Canada. Can anyone confirm if this is correct? I couldn't find anything from Health Canda that is equivalent to the US FDA GMP exempt, 510(k) exempt or OTC vs Rx rules. I contacted Health Canada and was directed to the standard rules for classification of devices.

Thanks in advance.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Thank you. Yes, class II, not IIa.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 25-Jan-2022 17:08
From: Kevin Randall, RAC
Subject: Class IIa OTC medical device for sale in Canada

Menstrual Cups are generally, and have traditionally been, considered by Health Canada to be Class II medical devices (though your particular indications could change this in accordance with the CMDR's Schedule 1 risk-based classification rules).  Indeed, there are lots of menstrual cups currently licensed for Canada that are in Class II; so, that should give you some confidence in that baseline classification.

Note also that in Canada, the four device classes are only I, II, III, and IV; there is no class IIa for Canada.

In general, for a manufacturer, the Health Canada premarket requirements for a Canadian class II device are generally as you say but with the exception that the manufacturer's Device License generally exempts the manufacturer from needing an Establishment License for the same device.  But the establishment's other separate operations involving other devices may separately trigger the need for an Establishment License.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Jan-2022 16:16
From: Erica Livingston
Subject: Class IIa OTC medical device for sale in Canada

Hello,

I am looking into the requirements of selling a product in Canada legally. The device is a menstrual cup and in the US it is class II, 510(k) exempt, not GMP exempt, OTC (no prescription required). In Canada, as far as I can tell, it is class IIa and there aren't any special rules, exceptions or carve-outs. This leads me to think we would need a medical device establishment license, a medical device license, and a MDSAP audit cert for submission to Health Canada. Can anyone confirm if this is correct? I couldn't find anything from Health Canda that is equivalent to the US FDA GMP exempt, 510(k) exempt or OTC vs Rx rules. I contacted Health Canada and was directed to the standard rules for classification of devices.

Thanks in advance.

------------------------------
Erica Livingston
Carlsbad CA
United States
------------------------------