Registering a Software medical device (SaMD) in China

[kreid]

Hello,
Does anyone know where I can find information (in English) on how one would register a software medical device in China?
Thanks

 

[Access2hc]

it is very similar to the IEC standards. The fastest way is to have it translated and then someone to verify the content.

if need help just ask.

Cheers,
Ee Bin
Access2hc

 

[jawlong]

Hi,
According to me, it will better to contact with the best Medical device manufacturing company like Peterstechnology.com. They will definitely make you confirm regarding the registration method.
Thank you

 

[swathi.sp]

Can any one please let me know, how to register Software as Medical Device for US FDA?

 

[shimonv]

Can any one please let me know, how to register Software as Medical Device for US FDA?

That's a very broad question. I suggest you start with the following FDA guidance document:
https://www.fda.gov/regulatory-info...ubmissions-software-contained-medical-devices

Shimon

 

[swathi.sp]

That's a very broad question. I suggest you start with the following FDA guidance document:
Content of Premarket Submissions for Software Contained in Med.Devices

Shimon

Thankyou shimon!