China - CFDA is now National Medical Products Administration or NMPA

[Marc]

As a note to all:

China's regulatory authority, the China Food and Drug Administration (CFDA) is now the National Medical Products Administration or NMPA. The NMPA has strict regulatory requirements, especially for foreign manufacturers who want to import their products to China.

 

[med_cert]

Are you familiar with information if regulatory requirements are now different than previous requirements?

 

[Marc]

I am not. Medical isn't my field. I just noticed the change today and thought it would be appropriate to note the change here. Marcelo should know.

 

[WendyLu33]

Are you familiar with information if regulatory requirements are now different than previous requirements?

I am familiar with Chinese registration regulations.

 

[med_cert]

I am familiar with Chinese registration regulations.

Can you describe any differences or just send a link to website where I can find it... thank you

 

[WendyLu33]

Can you describe any differences or just send a link to website where I can find it... thank you

Which or what kind of regulation(s) do you want to know?

As I know, the Regulation on the Supervision and Administration of Medical Devices is amended, and possibly will be released in this year. It changes a lot. But I only have Chinese version.

 

[Marc]

But I only have Chinese version.

Do you know if an English (or other language) translation will be available at some time in the future?

 

[WendyLu33]

Do you know if an English (or other language) translation will be available at some time in the future?

Sorry, I am not quite sure about this. If you really need English version urgently, you can ask translation company for help.