TRANSITION PERIOD FOR ADAPTATION TO THE CHANGE OF VERSIONS OF INTERNATIONAL STANDARDS

Hola, por favor, ¿alguien sabe sobre el período de transición para que los fabricantes se adapten al cambio de versiones de un estándar internacional, en China?

#NMPA - Administración Nacional de Productos Médicos

Translated via DeepL:
Hi, please does anyone know about the transition period for manufacturers to adapt to changing versions of an international standard, in China?

Dear,
Hello

I am not looking to register products in China. On the contrary, we import from China. What I want to know is if in the Chinese regulation for medical devices, when there is a change in the version of international standards used by the Chinese manufacturer, how much time does their legislation give them to adapt to this new version of the international standard.

Franky Zhang123 said:

If you want to register medical devices in China, NMPA only accepts Chinese standards. If needed, I can provide assistance

Click to expand...

Hi, can you provide details of recognized standards in China? I want to see if the tests we did in US match the Chinese standard

Optical medical device. Contains software too.