Regulatory Authority

National Medical Product Administration (NMPA)


Classification

I, II, III


Quality system

ISO 13485


Procedure

All medical devices are subject to registration.
The foreign manufacturer who intends to market medical devices in China must appoint an Authorized Representative (Legal Agent) responsible for submitting the documents required for the registration procedure with NMPA.

All Class I devices must be notified to the Competent Authority. Once the device has been notified, the NMPA issues a proper authorization (voucher) to market these products in China. All Class II and III devices must obtain the Registration Certificate with the NMPA. Class II and Class III manufacturers must carry out on-the-spot testing in accredited laboratories in China.


Applicant

Authorized Representative (Legal Agent)


Timeframe and costs

Class I devices (notification): a week

Class II and Class III devices (registration): from 12 to 22 months.
Government fees from 210.900,00 RBM to 308.800,00 RMB are currently required for Class II and Class III medical devices registration.


Validity

Notification validity: unlimited
Registration certificate validity: 5 years


Labeling and documentation language

Documentation and labeling must be provided in Chinese.


Useful information

The Legal Agent name shall be included in the Registration Certificate, together with the manufacturer’s one.