Research Use Only (RUO) Medical Devices in China

HeatherC-S

Starting to get Involved
#1
Hello. Does anyone know what the state of play is with regard to RUO medical devices in China? I know that any mention of them has been dropped from 2014 revised regulations, which has caused some to draw conclusion that their use is not permitted anymore. I just want a bit of clarification really. Many thanks
 
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Jamiechina

#3
Hello, I guess you are talking about IVD product?
In clause 15 of Provisions for In-vitro Diagnostic Reagent Registration(provisional)(Decree No.229 of China Food and Drug Administration 2007). It said 'Product needn't to be registered if it only use for research but not for clinical dignosis. "Reserch use only" must be marked on the outside'.
But some hosipital use RUO medical device for clinical dignosis, and this problem make CFDA facing lots of complain and lack useful method to control hospital(In China Hospital is managed by National Health and Family Planning Commission of the PRC). So in new version of Provisions for In-vitro Diagnostic Reagent Registration (Decree No.5 of China Food and Drug Administration) July 30,2014. it delete this clause. This's the background.
In 2016 2 hospital in Beijing was punished for using RUO Medical Devices. So now rare hospital dare to use RUO Medical Devices.
 
#4
Jamiechina,
So what is the new path to register research use only products in China?Does such a registration process exist as it looks like from your thread things have changed from no registration to something new.
 

Gamula

Involved In Discussions
#5
Hi,

I assume that the manufacturer needs a CFDA / SFDA certificate stating it is RUO IVD. Additionally, it must be labelled with RUO together with Chinese IFU. Finally, the shipping shall be announced at customs by your agent.

The backround: I send training material for clients to China, which is not registered or intended to be used for patients. We always receive clearance at the customs.

Maybe, this is helpful for you :agree:

Good luck and keepus up-to-date :popcorn:

Cheerio :magic:
 

regqual

Starting to get Involved
#6
Thanks for the reply. Got a new job and company is wanting to get into China for research of the medical device (not an IVD product). Searched eng.sfda.gov.cn and could not find the answer to: Which specific Decree/Order applies to R.U.O. products? Gamula stated a CFDA and IFU in Chinese needed (no problem there). What else do I need to get the product to a University or Hospital to further research our product?
 

Gamula

Involved In Discussions
#7
Dear RegQual,

to be honest you need a very good agent who has a business license to be your agent. Furthermore, use the Chinese CFDA Website and google translator. The only decree I know is the no. 650 but I do not know what is applicable for R.U.O.?!

Furthermore, the regulation jungle is tough not always applicable and for some exciting and for others frustrating.

Wish you a lot of success!

Best
J
 
#8
Hi,
According to me, it will better to contact with a reputed manufacturing industry like Peterstechnology.com. They will definitely make you conform regarding this type of medical cable.
Thank you
 
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