NMPA Technical Documentation
Medical device registration technical documentation requirements under NMPA are defined by Order No. 47 (2021) and Notice 2021-121.
Choose the dossier path by scenario
| Scenario | Applies to | Basis | Page |
|---|---|---|---|
| Initial registration (II/III) | New Class II/III | Notice 2021-121 Att.5 (6 chapters) | Sections below |
| Change registration | Substantive certificate changes | Att.7 | Change registration |
| Change filing | Administrative changes | Att.7 (filing) | Change filing |
| Renewal | Certificate renewal, no listed changes | Att.6 | Renewal |
| Class I filing | Class I products | Notice 2022-62 | Class I filing |
| Innovation special review | Innovation pathway qualification | 2018-127 guide | Innovation special review |
CRM / AI checklist generation must pick the correct scenario — do not apply the full initial 6-chapter list to change, renewal, or Class I filing.
Initial registration structure (6 chapters, Notice 2021-121 Att.5)
Chapter 1: Regulatory Information (监管信息)
| Section | Document | Ref |
|---|---|---|
| 1.1 | Table of Contents | Notice 2021-121, Ch.1 |
| 1.2 | Application Form | Notice 2021-121, Ch.1(二) |
| 1.3 | Glossary of Terms and Abbreviations | Notice 2021-121, Ch.1(三) |
| 1.4 | Product List (models, specs, configurations) | Notice 2021-121, Ch.1(四) |
| 1.5 | Associated Documents (business license, authorization, etc.) | Notice 2021-121, Ch.1(五) |
| 1.6 | Pre-submission Communication Records | Notice 2021-121, Ch.1(六) |
| 1.7 | Conformity Declaration | Notice 2021-121, Ch.1(七) |
Chapter 2: Product Summary (综述资料)
| Section | Document | Ref |
|---|---|---|
| 2.1 | Table of Contents | Notice 2021-121, Ch.2 |
| 2.2 | Product Overview (name, classification, intended use) | Notice 2021-121, Ch.2(二) |
| 2.3 | Product Description (structure, principle, materials, sterilisation) | Notice 2021-121, Ch.2(三) |
| 2.4 | Intended Use and Contraindications | Notice 2021-121, Ch.2(四) |
| 2.5 | Market History | Notice 2021-121, Ch.2(五) |
| 2.6 | Other Information | Notice 2021-121, Ch.2(六) |
Chapter 3: Non-Clinical Data (非临床资料)
| Section | Document | Ref |
|---|---|---|
| 3.1 | Table of Contents | Notice 2021-121, Ch.3 |
| 3.2 | Risk Management Data (risk analysis, evaluation, control, residual risk) | Notice 2021-121, Ch.3(二) |
| 3.3 | Essential Principles Checklist (医疗器械安全和性能基本原则清单) | Notice 2021-121, Ch.3(三) |
| 3.4 | Product Technical Requirements & Test Reports | Notice 2021-121, Ch.3(四) |
| 3.5 | Research Data (9 sub-categories, see below) | Notice 2021-121, Ch.3(五) |
| 3.6 | Non-Clinical Literature | Notice 2021-121, Ch.3(六) |
| 3.7 | Stability Studies (shelf-life, in-use, transport) | Notice 2021-121, Ch.3(七) |
| 3.8 | Other Data | Notice 2021-121, Ch.3(八) |
Chapter 3.5 Research Data Sub-categories
| Sub-section | Content |
|---|---|
| 3.5.1 | Chemical and Physical Performance |
| 3.5.2 | Electrical System Safety |
| 3.5.3 | Radiation Safety |
| 3.5.4 | Software Research (including cybersecurity, AI, interoperability) |
| 3.5.5 | Biological Characteristics (biocompatibility per ISO 10993) |
| 3.5.6 | Biological Source Material Safety |
| 3.5.7 | Cleaning, Disinfection, Sterilisation |
| 3.5.8 | Animal Studies |
| 3.5.9 | Other Safety and Efficacy Studies |
Chapter 4: Clinical Evaluation Data (临床评价资料)
| Section | Document | Ref |
|---|---|---|
| 4.1 | Table of Contents | Notice 2021-121, Ch.4 |
| 4.2 | Clinical Evaluation Data Requirements | Notice 2021-121, Ch.4(二) |
| 4.3 | Other Data | Notice 2021-121, Ch.4(三) |
Clinical evaluation pathways:
- Equivalent device pathway (同品种临床评价)
- Clinical trial pathway (临床试验)
- Exemption from clinical evaluation (免于临床评价, per published exemption list)
Chapter 5: IFU & Labels (产品说明书和标签样稿)
| Section | Document | Ref |
|---|---|---|
| 5.1 | Table of Contents | Notice 2021-121, Ch.5 |
| 5.2 | Instructions for Use (产品说明书) | Notice 2021-121, Ch.5(二) |
| 5.3 | Label Samples (标签样稿) | Notice 2021-121, Ch.5(三) |
| 5.4 | Other | Notice 2021-121, Ch.5(四) |
Chapter 6: QMS Documentation (质量管理体系文件)
| Section | Document | Ref |
|---|---|---|
| 6.1 | QMS Overview | Notice 2021-121, Ch.6(一) |
| 6.2 | Table of Contents | Notice 2021-121, Ch.6(二) |
| 6.3 | Manufacturing Information | Notice 2021-121, Ch.6(三) |
| 6.4 | QMS Procedures | Notice 2021-121, Ch.6(四) |
| 6.5 | Management Responsibility | Notice 2021-121, Ch.6(五) |
| 6.6 | Resource Management | Notice 2021-121, Ch.6(六) |
| 6.7 | Product Realisation | Notice 2021-121, Ch.6(七) |
| 6.8 | Measurement, Analysis, Improvement | Notice 2021-121, Ch.6(八) |
| 6.9 | Other QMS Procedures | Notice 2021-121, Ch.6(九) |
| 6.10 | QMS Inspection Documents | Notice 2021-121, Ch.6(十) |
Key Differences from EU MDR
| Aspect | NMPA | EU MDR |
|---|---|---|
| Structure | 6 chapters | Annex II (7 sections) + Annex III |
| Clinical evaluation | Equivalent device / Clinical trial / Exemption list | CEP + CER + PMCF (mandatory for all classes) |
| Type testing | Mandatory at NMPA-designated laboratories | NB decides testing scope |
| Product Technical Requirement | Unique NMPA document (产品技术要求) | No direct equivalent |
| Essential Principles | 安全和性能基本原则清单 (Attachment 9) | GSPR Annex I checklist |
| Software | Separate detailed requirements (AI, cybersecurity, interoperability) | Integrated into V&V section |
| QMS | Full QMS documentation in submission (Ch.6) | QMS assessed separately during NB audit |
| Post-market | Not part of registration dossier | Annex III (PMS Plan, PSUR) |
| Language | Chinese mandatory; foreign docs need translated copies | NB language preference |
Key Regulatory References
- Administrative Measures for Medical Device Registration and Filing (Order No. 47, 2021)
- Notice 2021-121: Registration Dossier Format and Content Requirements (Attachment 4 & 5)
- Attachment 9: Essential Principles Checklist (安全和性能基本原则清单)
- GB/T 42062-2022: Application of risk management (ISO 14971 adoption)
- GB 9706.1: Medical electrical equipment safety (IEC 60601-1 adoption)
- GB/T 16886 series: Biological evaluation (ISO 10993 adoption)