Regulatory Authority
National Medical Product Administration (NMPA)
Classification
I, II, III
Quality system
ISO 13485:2016
The foreign Manufacturer, who wants to place Medical Devices on the Chinese territory, must appoint an Authorized Local Representative (Legal Agent).
This person, based in the territory, is responsible for product registration, supervision of clinical trials, and post-market surveillance activities. Acting both as a liaison and a representative for all interactions with the NMPA, this person must have significant experience with relevant regulations and product standards.
All Class I Devices must be notified to the Regulatory Authority following a process based on submitting all documentation.
All Class II and III Devices are subject to registration: the device can only be placed on the market following authorization and registration certificate issued by the NMPA.
For Class II and III devices, technical testing in China at accredited laboratories is required.
With regard to on-site clinical investigations, they may be required for Class II and III devices.
Applicant
Legal Agent.
Timeframe and fees
Class I devices (notification): from 5 to 6 months
Class II and Class III devices (registration): from 15 to 32 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
Labelling and documentation language
Documentation and labelling must be provided in Chinese.
Useful information
The Legal Agent name shall be included in the Registration Certificate, together with the manufacturer’s one.
