MDSAP Participants 2019 - How many companies are participating YTD?

Berni

Starting to get Involved
#11
I'm confused. We, as a European manufacturer, are dealing with a Canada distributor, we told them we don't have MDSAP yet.
They know our product is FDA cleared in the USA. In their opinion, they can import/sell our devices because it is FDA cleared.
Is this true? I can't find any documentation regarding this.
 
#12
FDA allows several QA systems to qualify companies to offer items for sale (as long as you have a bona fide QA system that is audited and follows their requirements). Canada, on the other hand, made the MDSAP system the only system that is accepted for medical devices for sale in Canada. While the FDA will accept the MDSAP system, Canada only accepts the MDSAP system. It went into effect in January of this year.

Because of this, many manufacturers and distributors have elected to withdraw from the Canadian market , primarily due to the increased costs associated with performing the MDSAP. One way around it is to have a company who is currently registered in MDSAP take on your product under their system. Of course this is an added layer to the supply chain that increases costs all around. Somehow, Health Canada sees these added costs with reduced access to medical products as a benefit to the public, despite no guarantee that they can demonstrate validation and verification of efficacy (like we are expected to provide for our actions). I apologize for my crankiness.
 
#14
I found this on the Health Canada website FAQ:

Q1: I received a medical device licence using a Canadian Medical Device Conformity Assessment System certificate. Will my licence be suspended if I don’t have a Medical Device Single Audit Program certificate on January 1, 2019?

A1. All manufacturers of class II, III, and IV medical devices sold in Canada are required to transition to the Medical Device Single Audit Program. To maintain your medical device licences active, you must submit documented evidence of your transition to the Medical Devices Bureau by December 31, 2018.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#15
I'm confused. We, as a European manufacturer, are dealing with a Canada distributor, we told them we don't have MDSAP yet.
They know our product is FDA cleared in the USA. In their opinion, they can import/sell our devices because it is FDA cleared.
Is this true? I can't find any documentation regarding this.
Sounds weird to me too. Ask that distributor why they think so (i.e. to provide reference to some applicable clause).
 

Salisburysteve

Starting to get Involved
#16
I'm confused. We, as a European manufacturer, are dealing with a Canada distributor, we told them we don't have MDSAP yet.
They know our product is FDA cleared in the USA. In their opinion, they can import/sell our devices because it is FDA cleared.
Is this true? I can't find any documentation regarding this.
I strongly suspect that this is erroneous. We have a US distributor who were selling a similar product to our own in Canada and they have withdrawn it. Our product is FDA cleared and there was no hint in my conversations with HC that this was a green light. It is as Edward says in his post #12.
The mention of FDA was to do with the fact that if you have MDSAP then you wouldn't get an FDA inspector visiting. Had this from HC and.. my FDA inspector..

Regards,

Steve
 

Salisburysteve

Starting to get Involved
#18
Just had my letter from HC saying that I have 15 days before my licenses are suspended if they don't hear from me that I have a MDSAP plan in place. Currently our devices are still showing on MDALL.

Regards,
Steve
 

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