Registration vs Filing — Overview
China has two market entry pathways for medical devices: registration (注册) and filing (备案). The applicable pathway depends on device class.
The filing/registration split by device class — and in particular the three different levels of government responsible — is a China-unique feature of the regulatory system.
Pathway by class
| Class | Pathway | Authority | Typical timeline |
|---|---|---|---|
| Class I (domestic) | Filing (备案) | District/county-level authority | 1–3 months |
| Class I (imported) | Filing (备案) | National NMPA | 2–4 months |
| Class II (domestic) | Registration (注册) | Provincial NMPA bureau | 6–12 months |
| Class II (imported) | Registration (注册) | National NMPA | 12–18 months |
| Class III (domestic) | Registration (注册) | National NMPA / CMDE | 12–24 months |
| Class III (imported) | Registration (注册) | National NMPA / CMDE | 15–24 months |
What registration involves
Registration requires submission of a complete technical dossier to NMPA (or provincial bureau for Class II domestic). For Class III and imported devices, CMDE conducts the technical review. The review process may include supplemental information requests, on-site audits of testing facilities, and — for Class III domestic manufacturers — a pre-approval GMP inspection.
A registration certificate (注册证) is issued upon approval. It is valid for 5 years and must be renewed (re-registration — 重新注册) before expiry.
What filing involves
Filing is a lighter-touch process for Class I devices. The manufacturer submits a filing package to the local authority, which checks completeness but does not conduct a technical review of the safety and performance data. The filing is automatically accepted once completeness requirements are met.
Class I filing does not produce a "certificate" equivalent to a registration certificate — it produces a filing record number (备案号).
Detailed pathways
- Class I Filing
- Class II Registration
- Class III Registration
- IVD Registration
- Imported Device Registration
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.