Registration Dossier Requirements
The NMPA registration dossier (申报资料) is a comprehensive technical package demonstrating that a medical device is safe and effective. Requirements are set out in NMPA Order No. 47 and associated CMDE technical review guidelines.
Standard dossier sections
| # | Section | Key content |
|---|---|---|
| 1 | Application form | Device name, model, intended use, applicant details |
| 2 | Product overview | Description, principle of operation, components, materials |
| 3 | Research and development documentation | Design rationale, development history, literature references |
| 4 | Product technical requirements (PTR) | Performance specifications, testing methods, acceptance criteria |
| 5 | Testing reports | Performance testing, biocompatibility, sterility/microbial, electrical safety, EMC |
| 6 | Clinical evaluation | Clinical trial report, literature evaluation, or exemption justification |
| 7 | Product risk analysis | Risk management report per YY/T 0316 (ISO 14971) |
| 8 | Production information | Manufacturing process summary, critical materials, suppliers |
| 9 | QMS documentation | ISO 13485 certificate (importers) or GMP compliance summary |
| 10 | Labels and IFU | Label drafts, IFU draft (Chinese and, if applicable, original language) |
| 11 | Imported device documents | Free Sale Certificate, China Agent authorisation (imported only) |
Product Technical Requirements (PTR — 产品技术要求)
The PTR is a China-specific document that becomes part of the registration certificate. It defines the specifications and test methods against which the device is evaluated. Post-approval, the manufacturer must continue to manufacture to the registered PTR; deviations require a change supplement.
Testing report requirements
All performance testing must generally be conducted in NMPA-recognised testing institutions (国家药品监督管理局认可的检验机构). NMPA maintains an updated list of recognised testing laboratories on its website. Overseas test data conducted at internationally accredited laboratories (e.g. ISO/IEC 17025 accredited) may be accepted if accompanied by English translation and a statement of comparability to China testing standards.
Biocompatibility
Biological evaluation must follow YY/T 0268 (harmonised with ISO 10993 series). CMDE has published specific guidance on which ISO 10993 endpoints are required for different device-contact scenarios.
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After 'Testing report requirements' section heading, add: 'NMPA maintains a regularly updated list of recognised testing laboratories (国家医疗器械检测中心) on its official website. Manufacturers should verify that selected labs are on this list before submitting test reports. For certain testing types (e.g., biocompatibility, electrical safety), only NMPA-designated institutions may be accepted.'