A
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 !
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 !
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