Re-manufactured vs. Refurbished under FDA QSR

[Alex.Jo]

Hi, everybody

I'm quality manager in S.Korean medical device manufacturer. Recently, I have moved my occupation another medical manufacturer. And this company has refurbish business. But the remanufacturing license is only available under the Korea FDA (KFDA) regulation called 'KGMP'.

My wondering is whether it is possible that refurbish (or repair) business with trading other country regarding refurbished (or repaired, even though it is not manufactured by our company, however similar products we can manufacture) products.

And do we have to have remanufacturing license from FDA for refurbishing business (not speaking of other entity of country; e.g, China).

Please read below excerption (from medical device link)
"Therefore, the traditional protections of trademark law and false-advertising law may be the best avenues for combating shoddy or abusive repair and remaketing practices."

I have searched and read those materials of GHTF the 9th Working Shop 3 materials and summary highlighten as well as report. The report has only identified the business of refurbishment is being seriously embraced by large global manufacturers and the supply of refurbished medical device is becoming big business.

And also I tried to find out FDA website for any useful information about refurbish business. But failed. I understand important key concept is 'Intended Use', 'Safety' and 'Effectiveness' of medical device regarding refurbishing/remanufacturing.
Is there any useful information about refurbish from FDA web site?

Our company produce ultrasound diagnostic device, called 'Transducer'. It is only available to use after connect to ultrasound diagnostic system.

Needed help !

[Al Rosen]

In Reply to Parent Post by Alex.Jo

Hi, everybody

I'm quality manager in S.Korean medical device manufacturer. Recently, I have moved my occupation another medical manufacturer. And this company has refurbish business. But the remanufacturing license is only available under the Korea FDA (KFDA) regulation called 'KGMP'.

My wondering is whether it is possible that refurbish (or repair) business with trading other country regarding refurbished (or repaired, even though it is not manufactured by our company, however similar products we can manufacture) products.

And do we have to have remanufacturing license from FDA for refurbishing business (not speaking of other entity of country; e.g, China).

Please read below excerption (from medical device link)
"Therefore, the traditional protections of trademark law and false-advertising law may be the best avenues for combating shoddy or abusive repair and remaketing practices."

I have searched and read those materials of GHTF the 9th Working Shop 3 materials and summary highlighten as well as conclusions.
The GHTF conclusion recommended traditional

And also I tried to find out FDA website for any useful information about refurbish business. But failed. I understand important key concept is 'Intended Use', 'Safety' and 'Effectiveness' of medical device regarding refurbishing/remanufacturing.
Is there any useful information about refurbish from FDA web site?

Our company produce ultrasound diagnostic device, called 'Transducer'. It is only available to use after connect to ultrasound diagnostic system.

Needed help !

From what I understand, you would be considered a remanufacturer and required to list with FDA. Since you are a foreign establishment, you will need a US Agent. I suggest your first step is to find a US Agent located in California and experienced with Radiology devices. Then discuss your plans with the Agent.

[rogersr12]

I'm coming in a bit late on this since it was posted about 3 months ago, but in case it helps clear things up, as long as you don't take ownership of a device and are only repairing it as a service, then you are largely unregulated from a cGMP standpoint.
That doesn't necessarily preclude the FDA from issuing a warning letter for not following the cGMPs (as it has been known to happen) but FDA revoked CPG 7124.28 largely because it was inconsistent with the QSRs. Subsequent to this revocation, a different CPG was issued. CPG 7382.845 (Issued June 15, 2006) states that "Third party refurbishers, reconditioners, ... are currently not subject to the requirements of the Quality System Regulation"
If you are refurbishing and re-selling the product, however, you should definitely follow the advice already given.