Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

My company is considered as a Tier 1 Subcontract Manufacturer to most of the larger Orthopedic Manufacturers who resell and distribute our product (we hold the design) under their own name and branding.

We currently are registered and have a few of the medical devices licensed with Health Canada (MDALL) and hold the CMDCAS certification stamp with our ISO 13485 certification.

The Medical Devices Single Audit Program (MDSAP) will replace the current CMDCAS program.  In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after December 31st 2018.  Manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licenses.

Clarification is needed on the following questions:
1)  Will my company be required to transition to the MDSAP program since we are considered as a subcontract manufacturer and do not market the devices directly although we hold the design?
2)  Will we need to continue to license the devices within MDALL even though the CMDAS program will not be recognized?
3)  Will the company (that will be distributing the product) be responsible to list the devices with Health Canada using their brand name and product codes if we are not required?
4)  Can the larger Manufactures require their subcontract manufactures to hold the licenses and to implemented the MDSAP program?

I have done a lot of research and have attended some training courses but have not had any luck in finding the direct answer to any of the above questions.  It seems as if this MDSAP program is geared more towards direct manufacturers and not the subcontract manufacturers.
Your help in this matter is greatly appreciated.
Thank you.

 

In Canada, The legal manufacturer is the design owner. It doesn't matter who is the distributor (if it is a third party). You company (legal manufacturer) will require the MDSAP to maintain the licence of the approved products. I think the scope of MDSAP will be depending on the class of products .


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Ahmed Abouelnour
Etobicoke ON
Canada
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Original Message:
Sent: 31-May-2017 12:33
From: Anonymous Member
Subject: MDSAP Questions

This message was posted by a user wishing to remain anonymous

My company is considered as a Tier 1 Subcontract Manufacturer to most of the larger Orthopedic Manufacturers who resell and distribute our product (we hold the design) under their own name and branding.

We currently are registered and have a few of the medical devices licensed with Health Canada (MDALL) and hold the CMDCAS certification stamp with our ISO 13485 certification.

The Medical Devices Single Audit Program (MDSAP) will replace the current CMDCAS program.  In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after December 31st 2018.  Manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licenses.

Clarification is needed on the following questions:
1)  Will my company be required to transition to the MDSAP program since we are considered as a subcontract manufacturer and do not market the devices directly although we hold the design?
2)  Will we need to continue to license the devices within MDALL even though the CMDAS program will not be recognized?
3)  Will the company (that will be distributing the product) be responsible to list the devices with Health Canada using their brand name and product codes if we are not required?
4)  Can the larger Manufactures require their subcontract manufactures to hold the licenses and to implemented the MDSAP program?

I have done a lot of research and have attended some training courses but have not had any luck in finding the direct answer to any of the above questions.  It seems as if this MDSAP program is geared more towards direct manufacturers and not the subcontract manufacturers.
Your help in this matter is greatly appreciated.
Thank you.

 

Overall, the MDSAP requirements are gearing to assessing the quality management system. The additional supporting process for device registration do not change under MDSAP, but are really intended to integrate the overall requirements. If you don't do that part of the process, you would not be assessed on it under MDSAP. I would make sure you have (written) agreement of who is responsible for meeting the requirement. See my attempt at how I would answer your direct questions. Feel free to clarify if I have misinterpreted your situation.

1) In the same way you currently need the CMDCAS certificate to enable the device license, you will need a MDSAP certificate to enable the device license (MDSAP replaces CMDCAS).

2) The device licensing remains the same except MDSAP is being used for the quality management system certification method.

3) The MDSAP process does not change licensing, MDSAP has to do with your quality management system (same way CMDCAS does today). It is not clear that Health Canada will not separately change licensing, but that is a separate issue.

4) Again, MDSAP has to do with the quality management system (QMS). Larger manufacturers may want to require this in the same way they can require your QMS to meet other requirements (ISO 13485).

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 31-May-2017 12:33
From: Anonymous Member
Subject: MDSAP Questions

This message was posted by a user wishing to remain anonymous

My company is considered as a Tier 1 Subcontract Manufacturer to most of the larger Orthopedic Manufacturers who resell and distribute our product (we hold the design) under their own name and branding.

We currently are registered and have a few of the medical devices licensed with Health Canada (MDALL) and hold the CMDCAS certification stamp with our ISO 13485 certification.

The Medical Devices Single Audit Program (MDSAP) will replace the current CMDCAS program.  In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after December 31st 2018.  Manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licenses.

Clarification is needed on the following questions:
1)  Will my company be required to transition to the MDSAP program since we are considered as a subcontract manufacturer and do not market the devices directly although we hold the design?
2)  Will we need to continue to license the devices within MDALL even though the CMDAS program will not be recognized?
3)  Will the company (that will be distributing the product) be responsible to list the devices with Health Canada using their brand name and product codes if we are not required?
4)  Can the larger Manufactures require their subcontract manufactures to hold the licenses and to implemented the MDSAP program?

I have done a lot of research and have attended some training courses but have not had any luck in finding the direct answer to any of the above questions.  It seems as if this MDSAP program is geared more towards direct manufacturers and not the subcontract manufacturers.
Your help in this matter is greatly appreciated.
Thank you.

 

Are your products also sold in other countries, or only in Canada?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 31-May-2017 12:33
From: Anonymous Member
Subject: MDSAP Questions

This message was posted by a user wishing to remain anonymous

My company is considered as a Tier 1 Subcontract Manufacturer to most of the larger Orthopedic Manufacturers who resell and distribute our product (we hold the design) under their own name and branding.

We currently are registered and have a few of the medical devices licensed with Health Canada (MDALL) and hold the CMDCAS certification stamp with our ISO 13485 certification.

The Medical Devices Single Audit Program (MDSAP) will replace the current CMDCAS program.  In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after December 31st 2018.  Manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licenses.

Clarification is needed on the following questions:
1)  Will my company be required to transition to the MDSAP program since we are considered as a subcontract manufacturer and do not market the devices directly although we hold the design?
2)  Will we need to continue to license the devices within MDALL even though the CMDAS program will not be recognized?
3)  Will the company (that will be distributing the product) be responsible to list the devices with Health Canada using their brand name and product codes if we are not required?
4)  Can the larger Manufactures require their subcontract manufactures to hold the licenses and to implemented the MDSAP program?

I have done a lot of research and have attended some training courses but have not had any luck in finding the direct answer to any of the above questions.  It seems as if this MDSAP program is geared more towards direct manufacturers and not the subcontract manufacturers.
Your help in this matter is greatly appreciated.
Thank you.

 

This message was posted by a user wishing to remain anonymous

Julie,
Yes they are but not by us directly.  Again the product is sold and distributed by the OEM's.
Thank you,
Original Message:
Sent: 01-Jun-2017 12:46
From: Julie Omohundro
Subject: MDSAP Questions

Are your products also sold in other countries, or only in Canada?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 31-May-2017 12:33
From: Anonymous Member
Subject: MDSAP Questions

This message was posted by a user wishing to remain anonymous

My company is considered as a Tier 1 Subcontract Manufacturer to most of the larger Orthopedic Manufacturers who resell and distribute our product (we hold the design) under their own name and branding.

We currently are registered and have a few of the medical devices licensed with Health Canada (MDALL) and hold the CMDCAS certification stamp with our ISO 13485 certification.

The Medical Devices Single Audit Program (MDSAP) will replace the current CMDCAS program.  In accordance with Health Canada's announced MDSAP transition plan, CMDCAS certificates will no longer be accepted after December 31st 2018.  Manufacturers will be required to submit valid MDSAP certificates by no later than January 1st, 2019 in order to maintain their medical device licenses.

Clarification is needed on the following questions:
1)  Will my company be required to transition to the MDSAP program since we are considered as a subcontract manufacturer and do not market the devices directly although we hold the design?
2)  Will we need to continue to license the devices within MDALL even though the CMDAS program will not be recognized?
3)  Will the company (that will be distributing the product) be responsible to list the devices with Health Canada using their brand name and product codes if we are not required?
4)  Can the larger Manufactures require their subcontract manufactures to hold the licenses and to implemented the MDSAP program?

I have done a lot of research and have attended some training courses but have not had any luck in finding the direct answer to any of the above questions.  It seems as if this MDSAP program is geared more towards direct manufacturers and not the subcontract manufacturers.
Your help in this matter is greatly appreciated.
Thank you.