MDSAP Requirements

1 Reply

MDSAP Requirements

Posted by William Reinholt on Aug 20, 2018 6:56 am

I work for a contract medical device manufacturer that is FDA registered and ISO 13485 certified. Our customer is trying to get Canadian regulatory approval for his product we manufacture for him. As his company is the specification developer and distributor of the medical device, my understanding is that his company needs to comply with the MDSAP requirements. He believes we should be as the manufacturer of the device. Does anyone in the ASQ community have any experience or insight into this. Or possibly point me to some literature that could help clear this up for us? Any input would be appreciated. 



Re: MDSAP Requirements

Posted by Stephanie Gaulding on Oct 16, 2018 9:59 am

Hi William,

I'm not sure if you found an answer to your question from another source. If not, here's some information that you might find helpful.

This is an excerpt from Health Canada's FAQs on MDSAP transition:

Q7: I am a Distributor / Retailer / Private Label manufacturer. Do I still need a Medical Device Single Audit Program certificate?

A7: No. Distributors , retailers and private label manufacturers do not need a Medical Device Single Audit Program certificate. However, the Original Equipment Manufacturer (the company that manufactures your device) is subject to the Medical Device Single Audit Program requirements. If the Original Equipment Manufacturer does not plan to transition to Medical Device Single Audit Program and the licence(s) are cancelled, the product may not be sold or advertised, including stockpiled product (Sections 26 and 27 of the Medical Devices Regulations).

I highlighted the statement that refers to manufacturers being subject to MDSAP.

I typically use either the FDA's MDSAP website as a starting point for information on MDSAP. If you are manufacturing devices for distribution in Canada, Health Canada's MDSAP website may also be helpful.

Kind regards, 

Stephanie Gaulding, CQA, CPGP, Chair-Elect Human Development & Leadership Division and Principal Consultant @ DPS Group