Medical Device Regulatory Requirements in China
| Regulatory Authority |
National Medical Products Administration |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, II, III |
| Medical Device Regulations |
NMPA (CFDA) Regulation
| Click Here
|
| IVD Classification |
I,II,III |
| Registration Process |
Electronic regulated product submission (eRPS)
| Click Here
|
| Registration Timeline |
The timeframe of China NMPA medical device registration can vary from 12 to 22 months. The time length is dependent on the product, such as the classification, required testing, etc |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Chinese Language |
| Database |
Electronic regulated product submission (eRPS)
| Click Here
|
| Additional Information |
The NMPA approval for medical devices is valid for 5 years |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025