Custom-Made Devices
This page provides a plain English reference for custom-made devices requirements under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basisโ
Requirements for custom-made devices are set out in:
- MDSAR 2021 (State Council Order No. 739)
- Relevant NMPA technical guidelines published on www.cmde.org.cn
- Applicable YY/T and GB standards
Classification implicationsโ
Device type significantly affects classification. Consult the National Medical Device Classification Catalogue (NMDCC) for the applicable class for your specific product.
Key obligationsโ
Refer to CMDE technical review guidelines specific to this device type for the latest dossier requirements.
- NMPA โ www.nmpa.gov.cn
- CMDE โ www.cmde.org.cn
- NMPA Medical Device Registration Query โ datasearch.nmpa.gov.cn
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.
Custom-made devices (such as patient-specific implants manufactured to individual patient specifications) follow a streamlined registration pathway under NMPA Order No. 55. The applicant must register with a single clinical institution and provide evidence of medical necessity, material biocompatibility, sterilization validation, and labelling. A separate custom device registration certificate is issued for each patient or small batch. While simplified compared to mass-produced devices, custom devices still require NMPA approval before manufacturing. Batch modifications or use in additional patients require separate registration.