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