Glossary of Key Terms
Key English and Chinese terms used throughout RAPath CN and in NMPA regulatory documents.
A–D
| English | Chinese | Notes |
|---|---|---|
| Adverse event | 不良事件 | Must be reported to NMPA within defined timeframes |
| Annual report | 年度报告 | Registrant self-assessment submitted annually to NMPA |
| Borderline product | 界定产品 | Product requiring NMPA determination of regulatory category |
| CAPA | 纠正和预防措施 | Corrective and preventive action under GMP |
| China Agent | 境内代理人 | Mandatory legal representative for overseas manufacturers |
| Classification catalogue | 分类目录 | National Medical Device Classification Catalogue (NMDCC) |
| CMDE | 医疗器械技术审评中心 | Centre for Medical Device Evaluation — NMPA's technical review body |
| Custom-made device | 定制式医疗器械 | Device manufactured to individual specification |
F–M
| English | Chinese | Notes |
|---|---|---|
| Filing (备案) | 备案 | Simplified market entry for Class I devices |
| GMP | 生产质量管理规范 | Good Manufacturing Practice — NMPA production standard |
| IVD | 体外诊断试剂 | In vitro diagnostic reagent |
| MDSAR 2021 | 医疗器械监督管理条例 | Medical Device Supervision and Administration Regulations 2021 |
| Medical Device Production Licence | 医疗器械生产许可证 | Required for domestic manufacturers of Class II/III devices |
N–R
| English | Chinese | Notes |
|---|---|---|
| NMPA | 国家药品监督管理局 | National Medical Products Administration |
| NMDCC | 医疗器械分类目录 | National Medical Device Classification Catalogue |
| Post-market surveillance | 上市后监测 | Ongoing monitoring obligations after registration |
| Priority review | 优先审批 | Expedited review for innovative or rare-disease devices |
| Production Licence | 生产许可证 | Required for Class II/III domestic manufacturers |
| Registration (注册) | 注册 | Full registration process for Class II and III devices |
| Registration certificate | 注册证 | Valid 5 years; lists device, registrant, China Agent |
| Re-registration | 重新注册 | Certificate renewal every 5 years |
| Responsible Person | 质量负责人 | Named individual with personal quality accountability |
S–Z
YY/T 0287-2017 YY/T 0287-2017 China's national standard for medical device quality management systems; equivalent to ISO 13485:2016. Mandatory compliance required for GMP compliance.
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.
Add entries for: (1) 'Breakthrough Device' / '突破性医疗器械' — expedited designation; (2) 'Conditional Approval' / '条件批准' — approval with post-market conditions; (3) 'Responsible Person' / '质量负责人' — expanded definition noting personal accountability; (4) 'Change Supplement' / '变更申请' — type of post-approval notification; (5) 'Pre-submission Meeting' / '申前沟通' — CMDE pre-submission guidance meeting; (6) 'Dossier' / '技术资料' — complete regulatory submission package.