Chapter 1: Regulatory Information (监管信息)

NMPA Reference: Notice 2021-121, Attachment 5, Chapter 1
Document Code: NMPA-CH1
Responsible Party: Manufacturer / Authorized Representative (代理人 for imported devices)

Requirements Checklist

1.1 Table of Contents

• [ ] Include all first-level and second-level headings of the complete dossier
• [ ] Page numbers for each section

1.2 Application Form

• [ ] Completed per NMPA electronic submission system requirements
• [ ] Product name consistent across all documents
• [ ] Device classification code and category

1.3 Glossary of Terms and Abbreviations

• [ ] Define all specialised terms used throughout the dossier
• [ ] Define all abbreviations and acronyms
• [ ] Consistent terminology across all chapters

1.4 Product List

Provide in tabular format:

• [ ] Model numbers and specifications
• [ ] Structure and composition for each model/specification
• [ ] Accessories list
• [ ] Unique Device Identifier (UDI) or other identification codes for each variant
• [ ] Description notes (dimensions, materials, etc.)

1.5 Associated Documents

For domestic applicants:

• [ ] Copy of business license (营业执照副本)
• [ ] Innovative device approval notice (if applicable, per Innovation Special Review Procedure)
• [ ] Emergency approval notice (if applicable, per Emergency Approval Procedure)
• [ ] Contract manufacturing: contractor business license, contract, and quality agreement
• [ ] Import manufacturer producing in China: authorization letter + relationship/liability documentation

For foreign applicants:

• [ ] Company registration certificate from country of origin or competent authority proof
• [ ] Free Sale Certificate or equivalent market authorisation from country of origin
• [ ] Notarised documents (via e-notarisation or traditional notarisation)
• [ ] Authorized representative appointment letter + acceptance letter + business license copy
• [ ] Innovative / Emergency approval notices (if applicable)
• [ ] Contract manufacturing documentation (if applicable)

Master File Authorization (if applicable):

• [ ] Master file reference number
• [ ] Authorization letter from master file owner specifying authorised sections/pages

1.6 Pre-submission Communication Records

• [ ] List of all pre-submission meetings/communications with NMPA
• [ ] Previous submission receipt numbers (受理号) if resubmission
• [ ] Meeting minutes, presentation slides, final meeting records
• [ ] Outstanding questions from previous interactions and how they are resolved
• [ ] If not applicable: explicit declaration that no prior communication occurred

1.7 Conformity Declaration

The applicant must declare:

• [ ] Product complies with Administrative Measures for Medical Device Registration and Filing
• [ ] Product complies with Medical Device Classification Rules
• [ ] Product complies with applicable mandatory national (GB) and industry (YY) standards -- provide compliance checklist
• [ ] Authenticity declaration for all submitted materials (domestic: by applicant; imported: by both applicant and authorized representative)

Key Standards & References

• Administrative Measures for Medical Device Registration and Filing (Order No. 47, 2021)
• Notice 2021-121 (Attachment 4: Format Requirements; Attachment 5: Content Requirements)
• Medical Device Classification Rules (2015 Revision)
• UDI regulations: NMPA Announcement 2019 No. 66

Format Requirements (Attachment 4 Key Points)

• A4 paper format; one copy each (except Product Technical Requirement: two copies)
• Sequential pagination per second-level section
• All documents in Chinese; foreign documents require certified Chinese translations with originals attached
• Foreign applicant documents requiring notarisation: associated documents, conformity declarations, IFU, and labels
• Electronic documents required for: application form, Product Technical Requirement (editable Word), summary data, non-clinical summary, IFU (editable Word), clinical trial database