Class II Registration
Class II medical devices — those presenting moderate risk — must be registered with the provincial-level NMPA bureau (省级药品监督管理局) of the province where the manufacturer is located. For imported Class II devices, registration is with national NMPA.
Registration dossier
The Class II dossier (申报资料) includes all items required for Class III (see Dossier Requirements), scaled to the risk level of the device:
- Product overview and description
- Research and development documentation
- Production process documentation
- Product technical requirements
- Testing reports (performance, biocompatibility, sterility as applicable)
- Clinical evaluation (trial, literature, or exemption — see Clinical Evidence)
- Risk management summary
- Labels and IFU drafts
- QMS documentation summary
Review process
- Submission: dossier submitted online via NMPA platform to the provincial bureau
- Acceptance review: bureau checks completeness within 5 working days
- Technical review: bureau's review team evaluates the dossier (up to 60 working days, extendable)
- Supplemental information request (补充资料通知): if deficiencies are found, the applicant has up to 3 months to respond
- Decision: registration certificate issued, or application rejected with written reasons
Production licence (for domestic manufacturers)
Domestic Class II manufacturers must also hold a Medical Device Production Licence (医疗器械生产许可证) issued by the provincial bureau. The production licence covers the manufacturing site, product scope, and GMP status. A GMP inspection is normally required before the production licence is issued.
Certificate validity
A Class II registration certificate is valid for 5 years. Re-registration must be initiated at least 6 months before expiry.
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