MDSAP inquiry for China Contract Manufacturers

#1
Good day,

We are an iso 13485 mdsap licensed medical manufacturing company in canada.

Does our supplier in china making our products need to have mdsap in order to make our goods, as in finished product with private label, sterile. It is our label and contact information on the label, we are mdsap however they are not.
 
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shimonv

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#2
You supplier does not need to comply with MDSAP; it is sufficient for them to comply with ISO 13485.
MDSAP = ISO 13485 + RA requirements for the legal manufactures.

You are the legal manufacturer. The additional RA requirements are not relevant for your contract manufacturer; They are not selling your product to the Canadian market.

Shimon
 

shimonv

Trusted Information Resource
#4
ISO 13485 section 1 says:
"If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls."

So technically it's possible, but practically I don't think that all the countries participating in the MDSAP program allow it.
You should consult with your NB. I think you need to have a process for in-house as well as outsourced design and development.

Shimon
 

DannyK

Trusted Information Resource
#5
It depends on the classification of the product.
If the product is class 2 and only supplying the product to Canada, then it is not a requirement for the manufacturer to have design control in their system.
If class 3 or 4, it is required.
 
#6
I have mattresses built in China. This is a Class II Medical Device. I have a Canadian customer that wants to buy from China and have the mattresses shipped to Canada. Who needs to have MDSAP or ISO + RA. Can the Canadian Company be the manufacturer of record or the legal manufacturer?
 
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