Regulatory Open Forum

Hi everyone,

We’re new to Canadian regulation and entering with a combination device in Canada.The biological part is covered by the other manufacturer but we are responsible for registering the medical device.

Can you share some information on how to classify products in Canada and also what are the registration requirements to get our medical device approved.

Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

Hi Akanksha,

Medical Devices in Canada are regulated as per Medical Device Regulations SOR/98-282.
Classifications is done as per Schedule 1 of the Regs.

Thanks,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Original Message:
Sent: 16-Apr-2020 14:56
From: Akanksha Asbe
Subject: Canadian Regulation

Hi everyone,

We're new to Canadian regulation and entering with a combination device in Canada.The biological part is covered by the other manufacturer but we are responsible for registering the medical device.

Can you share some information on how to classify products in Canada and also what are the registration requirements to get our medical device approved.

Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------



Original Message:
Sent: 17-Apr-2020
From: Meenakshi Verma
Subject: RE: Canadian Regulation

Hi Akanksha,

Medical Devices in Canada are regulated as per Medical Device Regulations SOR/98-282.
Classifications is done as per Schedule 1 of the Regs.

Thanks,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Original Message:
Sent: 16-Apr-2020 14:56
From: Akanksha Asbe
Subject: Canadian Regulation

Hi everyone,

We're new to Canadian regulation and entering with a combination device in Canada.The biological part is covered by the other manufacturer but we are responsible for registering the medical device.

Can you share some information on how to classify products in Canada and also what are the registration requirements to get our medical device approved.

Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

We would be happy to assist you with your Canadian efforts.  There are a number of inputs that go into determining the product classification and device listing information for Health Canada application purposes.   

------------------------------
Sylvie Verdon; MS, RAC, MPM
Senior Consultant; REGSolutions, LLC
Principal Consultant; Verdon Solutions, LLC
RAPS Atlanta Chapter Co-Chair
Alpharetta, GA USA
------------------------------

Original Message:
Sent: 16-Apr-2020 14:56
From: Akanksha Asbe
Subject: Canadian Regulation

Hi everyone,

We're new to Canadian regulation and entering with a combination device in Canada.The biological part is covered by the other manufacturer but we are responsible for registering the medical device.

Can you share some information on how to classify products in Canada and also what are the registration requirements to get our medical device approved.

Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------

Hi Akanksha!

The nice people at Emergo have some great free resources to give you an overview of the process. Once you have classified your device, you will know how much supporting documentation will be required. Note that Health Canada requires that your quality management system is certified to ISO 13485 under the Medical Device Single Audit Program (MDSAP).

Cheers
Karen

------------------------------
Karen Long RAC
Vancouver BC
Canada
------------------------------

Original Message:
Sent: 16-Apr-2020 14:56
From: Akanksha Asbe
Subject: Canadian Regulation

Hi everyone,

We're new to Canadian regulation and entering with a combination device in Canada.The biological part is covered by the other manufacturer but we are responsible for registering the medical device.

Can you share some information on how to classify products in Canada and also what are the registration requirements to get our medical device approved.

Thank you!

---------------------------------
Akanksha Asbe
Regulatory Affairs Specialist II

Clinton MA
United States
---------------------------------