NMPA China Agent

Qserve as your China legal representative
China Agent

NMPA (National Medical Product Administration), before known as CDFA, requires any foreign manufacturers, who do not have a legal entity in China, to appoint a 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 an 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.
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Qserve China is able to act as your NMPA China agent, and to fulfill related requirements

Since 1st June 2021

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
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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
Your help in finding local distributors in China

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

How can we help you? Contact us