Taiwan Medical Device Product Approval Process using a Subcontractor

ISO 13485 - Medical

Involved In Discussions
#1
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
 
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somashekar

Staff member
Super Moderator
#2
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
Are you based in India .. ? We are going thru this for Thailand and I guess it is similar for Taiwan also.
 
E

eau2001

#5
Hi~

just happened to see this~~

What is your product?

the product is classified as Class 1, 2, or 3? Or, what is its product classification in US FDA database?
 

pseudoazurin

Involved In Discussions
#6
Just out of interest, where is the term "Legal Manufacturer" really from? Is it from one of MDD, FDA doc, GHTF doc or AHWP doc? Anyone got any idea?

Thx.
 

pseudoazurin

Involved In Discussions
#8
Yeah, I know the definition of "Manufacturer" can be found everywhere, but the term "Legal Manufacturer", which doesn't seems to be found anywhere in regulatoary doc. or standard, although it pops up from time to time in discussion.
 
M

MIREGMGR

#9
Yeah, I know the definition of "Manufacturer" can be found everywhere, but the term "Legal Manufacturer", which doesn't seems to be found anywhere in regulatoary doc. or standard, although it pops up from time to time in discussion.
In my experience, most users of that term are referring to the regulatorily responsible Manufacturer, as opposed to the physical maker in a contract manufacturing context or to other parties that might be interposed (particularly in an export/import context) between the physical maker and the regulatorily responsible Manufacturer.
 
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