Registration submission
Building and filing the registration dossier
The registration dossier follows a defined structure and is filed in Chinese. Review questions are normal; answering them quickly and completely is what keeps the timeline from slipping by months.
We compile the dossier, file it, and handle the review correspondence through to the registration certificate.
What this covers
- Dossier compilation in the required format, with translation
- Free sale certificate, quality system and manufacturing documentation
- Instructions for use and labelling in Chinese
- Filing and management of supplementary review questions
- Renewal and change registrations after approval
More on NMPA Certificate
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