Can a Contract Manufacturer "release" product on behalf of client to the market?

SGquality

Quite Involved in Discussions
#1
I have this question - could a Contract Manufacturer "release" product on behalf of client to the market? We have a Contract Manufacturer in China who compile the Device History Record (DHR) and conclude the particular lot of that product complies with the requirements. Then the product is shipped into US where our Quality will review the CoA, labels and review the DHR and then formally "release" the product to the market.

I know it is not allowed per 21 CFR 21/211 requirements and explicitly mentioned in Guidance Document on Quality Agreement, https://www.fda.gov/media/86193/download , is that allowed for medical devices? Do anyone have a similar experience?
 
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William55401

Involved In Discussions
#3
Good reply Shimon. In the device community, in the USA, with the exception of Management Responsibility, all elements can be outsourced. The challenge is how do you demonstrate oversight / control on the supplier(s)?
 

shimonv

Trusted Information Resource
#4
Good reply Shimon. In the device community, in the USA, with the exception of Management Responsibility, all elements can be outsourced. The challenge is how do you demonstrate oversight / control on the supplier(s)?
By choosing good suppliers, having robust manufacturing process, comprehensive quality agreement, good quality controls, and perhaps batch release from remote.
 

Edward Reesor

Trusted Information Resource
#5
The Quality System of the manufacturer of record (or design specifier, if that's the case) needs to have something in place that speaks to this very question. Their policies and procedures also have to cover these actions (for example, your shipping procedure also has to cover "drop shipping" from the manufacturing facility to the end user. One of the safer things to ensure is having the contract manufacturer possess and ISO 13485 certification, which is audited separately (plus other relevant certifications).
 
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