NMPA Renewal Registration Dossier

Source: Notice 2021-121 Attachment 6.
Chinese: 延续注册.

Prerequisite: no certificate-listed changes (or changes controlled under QMS without altering listed particulars). Substantive changes require change registration/filing first.

Lean structure

1. Regulatory information (prior certificate pack, declarations of no change, standards compliance notes)
2. Non-clinical — updated PTR only if PTR changed during validity; leftover non-clinical commitments
3. Clinical — only leftover clinical commitments on the certificate

Imported devices: home-country marketing authorization is not required for renewal.