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 China-recognised testing institutions (国家药品监督管理局认可的检验机构). NMPA maintains a list of recognised testing laboratories. Some overseas test data may be accepted with additional supporting documentation.
Biocompatibility
Biological evaluation must follow YY/T 0268 (equivalent to ISO 10993 series). CMDE has published specific guidance on which ISO 10993 endpoints are required for different device-contact scenarios.
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