How to get CFDA/NMPA approval?
To gain a foothold in the Chinese market, medical device companies must obtain the approval of the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration or CFDA.
Under the NMPA, medical devices are classified as follows:
Class I:
The safety and effectiveness of the device can be ensured through routine registration.
Class II:
The safety and effectiveness of the device require a certain degree of control.
Class III:
The device is implanted into the human body, used for life support or sustenance; or poses potential risk to the human body, and thus must be stringently controlled to ensure safety and effectiveness.
When applying for NMPA approval, we suggest that you:
- Appoint a local Chinese agent to coordinate your NMPA effort.
- Implement ISO 13485 (quality system requirements of medical devices) as part of the process.
- Follow NMPA guidance that all testing be carried out by a NMPA authorized Medical Device Evaluation Center.
How can we help?
GEMARMED’s experience in making the right connections with local Chinese agents, preparing the required documentation and arranging the required testing will ensure a smooth process for NMPA approval.