What is the final presentation dossier for the NMPA composed of?

[IS1027]

Hello everyone, just needed to ask a few quick questions regarding the final presentation dossier for a registration in China.

1) Are all the documents presented by the manufacturer (originals) included in the dossier, or just the Chinese translations? Or both are included?

2) Do all the documents presented by the manufacturer (originals) need to be signed? Not talking specifically about important documents like CER, PMS, biocompatibility studies and such, but mostly about "auxiliary" documents that maybe provide just some little piece of information/data the Chinese agent needed, and that were custom made to present that data instead of doing it by, for example, email.

Thank you!

 

[Franky Zhang123]

1、just the Chinese translations.
2、need to be signed.

 

[Orca1]

According to the "Provisions for In-vitro Diagnostic Reagent Registration (Abolished)", Article 14 states that "The documents for registration application or filing shall be in Chinese, where they are translated from a foreign language, the original documents shall also be provided at the same time."

And although this is not for med devices, this is also echoed in the "NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings" where it states that "Drug substance release or shelf-life specifications in Chinese and English versions, test methods and relevant method validation data...".