Labeling requirements for Type Testing

IS1027 · Jun 7, 2023

I know that for commercialization (after the medical device has been approved), the NMPA requires labels and IFU to be in Chinese.
But how about for Type Tests to be done during the registration process? Can the sample products be supplied with English (or other language) labels, and not Chinese?
Thanks in advance!

IS1027 · Jun 11, 2023

Franky Zhang123 said:
During the registration process, the NMPA requires labels and IFU to be in Chinese too.
If you guys have trouble with this, I can help for free.

Thanks Franky. Sorry, but that applies to Type Testing as well?
Or can the manufacturer do the Type Testing with labels in English, and only then for the final dossier presentation change the labels into Chinese?

Like:
1) Type Testing with English labels/leaflet
2) Final dossier presentation with Chinese labels/leaflet
Is this possible?

RY0302 · Aug 15, 2023

IS1027 said:
Thanks Franky. Sorry, but that applies to Type Testing as well?
Or can the manufacturer do the Type Testing with labels in English, and only then for the final dossier presentation change the labels into Chinese?

Like:
1) Type Testing with English labels/leaflet
2) Final dossier presentation with Chinese labels/leaflet
Is this possible?

No, Testing lab requires the Label/IFU in Chinese , as the label and IFU are checked against Chinese standards by testing Lab. Lab needs to includes label in testing report.

Labeling requirements for Type Testing

IS1027

Starting to get Involved

IS1027

Starting to get Involved

RY0302

Registered

Similar threads