We are a small medical device company that outsource all our manufacturing, but perform the final release onto the market place.
We are about to start the product approval process in Taiwan with our distributor.
The distributor keeps asking for a free sales certificate from our subcontractor with our product, this I know is not going to happen as we are the legal manufacturer.
The subcontractor is ISO 13485 approved and also are approved in Taiwan for there own products.
I am also being asked for all the subcontractors procedure for the product and how they deal with recall etc but this is controlled via all our own procedures.
Can anybody tell what should happen with regards to product approval in Taiwan using a subcontractor?
Thanks in advance
We are about to start the product approval process in Taiwan with our distributor.
The distributor keeps asking for a free sales certificate from our subcontractor with our product, this I know is not going to happen as we are the legal manufacturer.
The subcontractor is ISO 13485 approved and also are approved in Taiwan for there own products.
I am also being asked for all the subcontractors procedure for the product and how they deal with recall etc but this is controlled via all our own procedures.
Can anybody tell what should happen with regards to product approval in Taiwan using a subcontractor?
Thanks in advance