NMPA China Agent

Qserve as your China legal representative
China Agent

Your first contact point for mutual communication

NMPA (National Medical Product Administration), before known as CDFA, requires any foreign manufacturers, who do not have a legal entity in China, to appoint one and only one China Agent when they initiate product registration process.

This China agent needs to be a fully established legal company with a physical address within mainland China. China agent’s name, address, contact details shall be listed on the approved product certificate, application form, product IFU, and labels of all classes of medical devices. China agent also needs to notify the local authority of clinical investigation within China. Once assigned, your China Agent will be the first contact point for mutual communication with NMPA both pre- and post-market placement.
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China Agent responsibilities

NMPA has implemented updated Regulation for Medical Device Administration and Supervision (State Council Order 739) to replace the Medical Device Regulations Order 680. 2018 version. In the Order 739, China agent’s roles and responsibilities have been revised to be: 

China agent's role is to support foreign legal manufacturer to perform the following obligations:
• Establish a quality management system (QMS) suitable for products and maintain effective operation
• Formulate post market research and risk management plan and ensure its effective implementation
• Carry out adverse event monitoring and reevaluation based on regulation
• Establish and implement product traceability and recall system
• Other obligations stipulated by NMPA under the State Council

China Agent change

The change of appointed China agent will trigger the certificate change notification to NMPA.

Class I device agent role is normally binding in the initial applicant’s registered system and may not be easily transferred unless it is handled properly by your partner in the beginning.
Class II and class III devices’ China agent may be transferred once agreed with the current agent holder. China agent is sometimes confusingly mixed with after-sale service agent and distributors. Only China agent information is required to be listed on the product certificate. Each certificate may appoint only one China agent. While the after-sale service agents and/or distributor could be multiple per certificate and be flexible to change without notification to NMPA upon change. China agent could be an independent role, apart from sales or after-sales activities.

Services

Qserve as your China Agent

Fully established legal company
Physical address in mainland of China
Your first contact point for mutual communication with NMPA
Help transfer your China agent to the new designation

We can address and discuss the changes of the required services and responsibilities

How can we help you? Contact us