RFID (radio frequency identification) registration for Medical Device

[QAengineer13]

Please share with me your experience of registering Medical device/IVD with RFID? I would like to know if the medical device registration and RFID registration in respective countries can happen parallely or does the product needs to registered before RFID registration, any input in relation to this wil be greatly appreciated!

 

[Marc]

A quick "Bump". Could be an interesting discussion. My Thanks in advance to anyone who will help with this one.

 

[yodon]

Not my area of expertise by any means but in the spirit of trying to get the ball rolling, I'll toss in.

I'm really not aware of any registration that's required. Generally, I think, everything would be covered in product safety testing. I poked around and found the MET labs (no ties) had a fairly informative page: https://www.metlabs.com/industries/rfid/

You might consider getting in touch with someone there to provide details.

 

[QAengineer13]

Thank you Marc and Yodon for jumping in to provide some help.

Yodon, I have already worked out the RFID registration requirement for different countries for example EU its the RED Directive and so on, the question was about the registration and even in that space I spoke to someone who has registered product with RFID recently and the answer seems to be country specific and they can be mostly done concurrently/ parallel with the MD/IVD registration.

Thank you, very much appreciate your input!

 

[Highground]

Not my area of expertise by any means but in the spirit of trying to get the ball rolling, I'll toss in.

I'm really not aware of any registration that's required. Generally, I think, everything would be covered in product safety testing. I poked around and found the MET labs (no ties) had a fairly informative page: RFID Testing for Safety, EMC, and Tag & Reader Interoperability

You might consider getting in touch with someone there to provide details.

This has helped me greatly! Can't find many test labs that can carry out this testing to meet the FDA requirements.

 

[Highground]

MET labs are unable to do the required testing for our Heart/Lung Machine with a new device that we need to test before our submission.
The labs are unable to reach the frequencies or levels of modulation.

Any suggestions?

AIM 7351731, Medical electrical equipment and system electromagnetic immunity test for exposure to radio frequency identification readers

 

[yodon]

Look for other test labs that can. Off the top of my head, consider checking UL, Intertek, & Nemko (I have no skin in any of those games).