Testing in China accepted by the USFDA

[Jennifer27]

Dear Experts,

We are working on a Blood Glucose Monitoring device. We are looking to perform electrical safety and EMC testing per IEC standards to support a submission to the FDA. We requested quotes from lots of labs. One quote was from TUV SUD China. We are interested in doing our testing in China because our contract manufacturer is in China.

I am wondering if we get testing done in China, will it be acceptable by the FDA as long as its executed by an accredited lab and per internationally recognised standards like the IEC 60601?

Please advise.



Jen

 

[Pads38]

As long as the testing is within the scope of the lab's ISO 17025 accreditation I cannot think that there would be any problem.

 

[J0anne]

The testing can be undertaken anywhere, just make sure your certification is genuine.

 

[MIREGMGR]

We have biocompatibility testing done quite often by an appropriately certified and credentialed lab in China. We've submitted reports from that lab in relation to 510(k) processes without the test lab being a problem.

It of course is always necessary to follow FDA's requirements and expectations as to procedure...not just the minimum per the standard, but whatever FDA expects per their guidances.

 

[Jennifer27]

Thank you, appreciate your responses!