China NMPA Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for China.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Regulations for the Supervision and Administration of Medical Devices | 680 | 2017 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Guidance on Clinical Evaluation of Medical Devices (Chinese) | 14 | 2015 | |
| Log in | Guidance on Technical Review of Medical Device Software (Chinese) | 50 | 10/2015 | |
| Log in | Provisions for IFUs and Labels (Chinese) | 6 | 2014 | |
| Log in | Provisions for Medical Device Registration | 4 | 2014 | English |
| Log in | Provisions for IVD Reagent Registration | 5 | 2014 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Medical Device Registration Dossier Requirements (Chinese) | 43 | 2014 | |
| Log in | Guidance on Class I Device Record Filing (Chinese) | 26 | 2014 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Announcement No. 83 of 2018, Special Review Procedures for Innovative Medical Devices (Chinese) | 2018 | ||
| Log in | SAMR Order No. 1 of 2018, Regulations on Medical Device Adverse Events Monitoring and Re-evaluation (Chinese) | 2018 |
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