Regulatory Open Forum

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Hello Vicki,

Guess I am a little confused by the question.  Health Canada has nothing to do with EU MDD or EU MDR - Health Canada has their own regulations.  The Canada Medical Device Regulations SOR-98/202 do not have anything to do with the EU MDD or EU MDR, although the classification of devices are similar there are still some slight differences.  Canada has its own submission process to obtain Medical Device Licenses (MDL) and has nothing to do with CE Marking.  There has been indications and rumours that Health Canada are going to update their regulation to align with other regulations, including their requirement under Medical Device Single Audit Program (MDSAP).  The regulation while some slight updates over the years is from 1998 and quite old now.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Aug-2023 02:25
From: Agnieszka Fronczak
Subject: Health Canada MDD to MDR Transitioning

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Thank you Richard for the feedback on our question. I am fairly new in the regulatory space (career transitioned) and I am still learning about requirements of the various global countries. Thanks for the clarity.

Much appreicated,

Vicki

Hello Vicki,

Guess I am a little confused by the question.  Health Canada has nothing to do with EU MDD or EU MDR - Health Canada has their own regulations.  The Canada Medical Device Regulations SOR-98/202 do not have anything to do with the EU MDD or EU MDR, although the classification of devices are similar there are still some slight differences.  Canada has its own submission process to obtain Medical Device Licenses (MDL) and has nothing to do with CE Marking.  There has been indications and rumours that Health Canada are going to update their regulation to align with other regulations, including their requirement under Medical Device Single Audit Program (MDSAP).  The regulation while some slight updates over the years is from 1998 and quite old now.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Aug-2023 02:25
From: Agnieszka Fronczak
Subject: Health Canada MDD to MDR Transitioning

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Hi Vicki,

As Richard mentioned, the Health Canada licensing process does not rely on CE marking.  All Class II-IV medical devices to be marketed in Canada must be licensed by Health Canada.  

If a product that is already marketed in both Canada and EU (i.e. it is CE marked) is undergoing the transition from MDD to MDR certification, any changes to the device in relation to the MDR certification (e.g. labelling) must be assessed per the Canadian Medical Devices Regulations and Health Canada guidance to determine whether action (e.g. an amendment) is required to market the updated product in Canada.

Hope this is helpful!

Best Regards,

Thank you Richard for the feedback on our question. I am fairly new in the regulatory space (career transitioned) and I am still learning about requirements of the various global countries. Thanks for the clarity.

Much appreicated,

Vicki

Hello Vicki,

Guess I am a little confused by the question.  Health Canada has nothing to do with EU MDD or EU MDR - Health Canada has their own regulations.  The Canada Medical Device Regulations SOR-98/202 do not have anything to do with the EU MDD or EU MDR, although the classification of devices are similar there are still some slight differences.  Canada has its own submission process to obtain Medical Device Licenses (MDL) and has nothing to do with CE Marking.  There has been indications and rumours that Health Canada are going to update their regulation to align with other regulations, including their requirement under Medical Device Single Audit Program (MDSAP).  The regulation while some slight updates over the years is from 1998 and quite old now.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Aug-2023 02:25
From: Agnieszka Fronczak
Subject: Health Canada MDD to MDR Transitioning

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Thank you Camille for your response, 

There was a section on the Health Canada application form (Health Canada Pub.: 220283) that threw me off:

16.Review Documents -
A)Indicate that labelling material is included as an attachment to this application. Manufacturers of Class II medicaldevice must submit their device label as required by section 32(2)(d) of the MDR. Refer to the documents Guidance for the Labelling of Medical Devices and Guidance for the Labelling of In Vitro Diagnostic Devices

that was why we were thinking that Health Canada would eventually follow MDR format??? Unless "MDR" means something else? My company is not an IVD company, so this doesnt apply to us.

Thanks,

Vicki

Hi Vicki,

As Richard mentioned, the Health Canada licensing process does not rely on CE marking.  All Class II-IV medical devices to be marketed in Canada must be licensed by Health Canada.  

If a product that is already marketed in both Canada and EU (i.e. it is CE marked) is undergoing the transition from MDD to MDR certification, any changes to the device in relation to the MDR certification (e.g. labelling) must be assessed per the Canadian Medical Devices Regulations and Health Canada guidance to determine whether action (e.g. an amendment) is required to market the updated product in Canada.

Hope this is helpful!

Best Regards,

Thank you Richard for the feedback on our question. I am fairly new in the regulatory space (career transitioned) and I am still learning about requirements of the various global countries. Thanks for the clarity.

Much appreicated,

Vicki

Hello Vicki,

Guess I am a little confused by the question.  Health Canada has nothing to do with EU MDD or EU MDR - Health Canada has their own regulations.  The Canada Medical Device Regulations SOR-98/202 do not have anything to do with the EU MDD or EU MDR, although the classification of devices are similar there are still some slight differences.  Canada has its own submission process to obtain Medical Device Licenses (MDL) and has nothing to do with CE Marking.  There has been indications and rumours that Health Canada are going to update their regulation to align with other regulations, including their requirement under Medical Device Single Audit Program (MDSAP).  The regulation while some slight updates over the years is from 1998 and quite old now.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Aug-2023 02:25
From: Agnieszka Fronczak
Subject: Health Canada MDD to MDR Transitioning

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Thank you Richard for the feedback on our question. I am fairly new in the regulatory space (career transitioned) and I am still learning about requirements of the various global countries. Thanks for the clarity.

Much appreicated,

Vicki

Hello Vicki,

Guess I am a little confused by the question.  Health Canada has nothing to do with EU MDD or EU MDR - Health Canada has their own regulations.  The Canada Medical Device Regulations SOR-98/202 do not have anything to do with the EU MDD or EU MDR, although the classification of devices are similar there are still some slight differences.  Canada has its own submission process to obtain Medical Device Licenses (MDL) and has nothing to do with CE Marking.  There has been indications and rumours that Health Canada are going to update their regulation to align with other regulations, including their requirement under Medical Device Single Audit Program (MDSAP).  The regulation while some slight updates over the years is from 1998 and quite old now.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Aug-2023 02:25
From: Agnieszka Fronczak
Subject: Health Canada MDD to MDR Transitioning

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------

Hi Vicki, welcome to the regulatory environment! You will find stimulating discussions and Q&As on a great variety of subjects on this Forum. 

'Similar but not the same' is something you will encounter frequently in the arena of worldwide medical device regulations. Both within a regulation, and also when comparing regulations. I think it is no surprise that the regulatory system of Canada resembles the EU regulatory system for medical devices; Canada is a member of the Commonwealth. With the UK being a member of the European Union between 1973 and 2020 the EU medical device regulatory system was used by other countries of the Commonwealth to set up their own medical device regulatory system. Similar enough to ensure easy access to Commonwealth countries and the EU.

Thank you Richard for the feedback on our question. I am fairly new in the regulatory space (career transitioned) and I am still learning about requirements of the various global countries. Thanks for the clarity.

Much appreicated,

Vicki

Hello Vicki,

Guess I am a little confused by the question.  Health Canada has nothing to do with EU MDD or EU MDR - Health Canada has their own regulations.  The Canada Medical Device Regulations SOR-98/202 do not have anything to do with the EU MDD or EU MDR, although the classification of devices are similar there are still some slight differences.  Canada has its own submission process to obtain Medical Device Licenses (MDL) and has nothing to do with CE Marking.  There has been indications and rumours that Health Canada are going to update their regulation to align with other regulations, including their requirement under Medical Device Single Audit Program (MDSAP).  The regulation while some slight updates over the years is from 1998 and quite old now.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Aug-2023 02:25
From: Agnieszka Fronczak
Subject: Health Canada MDD to MDR Transitioning

Hi Vicky, 

I am not sure, but I suppose as soon as the MDD directive is valid and your prodcuts are certificated acc.to it, Health Canada willl aso accept MDD. The most important is, you must have a valid EC certificate 

Until now, I did not hear about any transition times from MDD to MDR to Canada market therefore I assume,  they acccept EU transition regulations. 

Could someone maybe help? 

Thanks, Agnes 

------------------------------
Agnieszka Fronczak
Senior Manager Regulatory Affairs
Neu-Ulm
Germany

Original Message:
Sent: 11-Aug-2023 18:56
From: Vicki Ong
Subject: Health Canada MDD to MDR Transitioning

Hello RAPS members,

I am looking to see if anyone is familiar with Health Canada registration. When is Health Canada transitioning from MDD to MDR?  When is the last date they will accept applications under MDD if they have not yet transitioned?

Thanks,

Vicki

------------------------------
Vicki Ong
Regulatory Affairs Specialist
Lake Forest CA
United States
------------------------------