| 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 |
| Device Classification Guidelines | CFDA New Medical Device Classification Catalogue | Click Here |
| 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 |
| Technical Documentation Format |
Section IV Product Registration (II) Product technical requirements; (III) Test report of the product; (IV) Clinical evaluation materials; (V) Product IFU and label sample; (VI) Documents of quality management system related to product development and manufacturing; (VII) Other materials necessary for demonstrating the safety and effectiveness of products. | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Chinese Language |
| Labeling Requirements |
The applicant or filing entity shall prepare the instructions for use (IFU) and labels for medical device to be registered or filed. The IFU and labels of product shall conform to the requirements specified in Article 39 of the Regulations on Supervision and Administration of Medical Devices and relevant provisions. |
| Clinical Trials Information |
Section II Clinical Evaluation | Click Here |
| Database | Electronic regulated product submission (eRPS) | Click Here |
| Additional Information | The NMPA approval for medical devices is valid for 5 years |
| Contact Phone | 978-390-4453 |
| Contact Email | info@chinameddevice.com |
| Contact Address | Suite 1702C, Beijing Hailongshiyou Building, Chaoyang District, Beijing |