China Device Assisted Technology Clinical Trial

[fialor]

Does anyone know if clinical trials involving device assisted technology (existing drug available and new device not available in China) requires registration/approval with the SMRA?

I am aware that new drugs or new versions of drugs, both manufactured in China and being imported which are being used in trials require registration/approval. But I am unclear on the above.

Thanks for the help!

 

[fialor]

Does anyone know if clinical trials involving device assisted technology (existing drug available and new device not available in China) requires registration/approval with the SMRA?

I am aware that new drugs or new versions of drugs, both manufactured in China and being imported which are being used in trials require registration/approval. But I am unclear on the above.

Thanks for the help!

Anyone?

 

[shimonv]

Hi fialor,
A clinical trial in China is something you start but you don't know when it will finish, and it's very expensive. Therefore it's best, in my opinion, to approach CFDA directly with this question.
My intuition says that if the assisting device is not approved in China you can get challenged about its reliability, performance, safety, and effect on the drug.
I don't think you can take such a risk on yourself.


Hope it helps.

Shimon

 

[jawlong]

Hi,
I think it will better to contact with Peter's Technology (Suzhou) Co., Ltd.. They will definitely provide you the best & quality devices with clinically tested. I have recently purchased a bulk amount of medical devices from them.
Thank you

 

[Marc]

Are you affilliated with them in any way?