Hi there,
This is my first post to the Cove (but I come here often to read many interesting threads), I hope it will be of interest for some of you.
My question today is about MDSAP. I work for a manufacturer of a low risk medical device (ISO13485 certified), and we are selling in all participating countries, except Japan.
As many other manufacturers, we feel obligated to enroll to this MDSAP because of the Canadian market. At first, we thought this audit will help us for the Canadian market and the USA, so we believed that we could ask our AO to only include those two countries in the scope of the audit.
We were wrong, as I already read at different places that the scope of this audit will need to include every participating countries where we market our device.
However, my question is the following one: what is the point of obtaining a MDSAP certificate for Brazil, even though we do not need a B-GMP certificate and we are not subject to a possible ANVISA inspection ? (Our device is registered through a "cadastro" in Brazil). The same question applies for Australia, where our CE + ISO 13485 certificates are sufficient.
It seems to us that including those countries in the scope will result in a longer audit, increased fee, and total waste of resources... All of this to satisfy Health Canada
Thanks in advance for any comments about this !
This is my first post to the Cove (but I come here often to read many interesting threads), I hope it will be of interest for some of you.
My question today is about MDSAP. I work for a manufacturer of a low risk medical device (ISO13485 certified), and we are selling in all participating countries, except Japan.
As many other manufacturers, we feel obligated to enroll to this MDSAP because of the Canadian market. At first, we thought this audit will help us for the Canadian market and the USA, so we believed that we could ask our AO to only include those two countries in the scope of the audit.
We were wrong, as I already read at different places that the scope of this audit will need to include every participating countries where we market our device.
However, my question is the following one: what is the point of obtaining a MDSAP certificate for Brazil, even though we do not need a B-GMP certificate and we are not subject to a possible ANVISA inspection ? (Our device is registered through a "cadastro" in Brazil). The same question applies for Australia, where our CE + ISO 13485 certificates are sufficient.
It seems to us that including those countries in the scope will result in a longer audit, increased fee, and total waste of resources... All of this to satisfy Health Canada
Thanks in advance for any comments about this !