Cina

The information on this page is valid and current as of January 2019. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer


 

Regulatory Authority:
National Medical Product Administration (NMPA)

Classification:
I, II, III

Quality system:
ISO 13485

Procedure:

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.

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Applicant:
Legal Agent

Timeframe and costs:
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.

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