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

[SGquality]

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?

 

[shimonv]

Hi,
There is no such regulatory restriction with medical devices. Your contract manufacturer can send the devices directly to the client with adequate labelling. Of course, there are QA arrangements to be made and you remain the legal entity with all that it entails.

Shimon

 

[William55401]

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]

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]

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).

 

[alag]

Hi,
There is no such regulatory restriction with medical devices. Your contract manufacturer can send the devices directly to the client with adequate labelling. Of course, there are QA arrangements to be made and you remain the legal entity with all that it entails.

Shimon

How does this fit with the PRRC requirement 15.3.a from the MDR?

 

[shimonv]

Hi alag,
The PRRC is responsible for the compliance of the product, whether manufactured in-house or by a sub-contractor.

Shimon

 

[alag]

Hi alag,
The PRRC is responsible for the compliance of the product, whether manufactured in-house or by a sub-contractor.

Shimon

Hello,
The question is how practically this is done.
PRRC (for company with more that 50 people) is supposed to an employee of the manufacturer. Is he/she supposed to (remotely) check and sign every batch that is produced by the contract manufacturer? or the contract manufacturer should release products independently on the base that this is covered in the Quality agreement?
Do you have any experience of what practically NBs are expecting in this scenario?
thanks

 

[Ed Panek]

When we used a CM our company would review and sign off on the DHR (Batch Records) before they could ship our devices.

 

[shimonv]

NB's would typically expect to see (a) quality agreement in place, (b) ISO certificate for the contract manufacturer, (c) results of onsite or remote audit for the contract manufacturer, and (d) reviewed and approved DHRs.