NMPA China Agent

Qserve as your China legal representative
China Agent

Your independent legal representation

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 obiligations stipulated by NMPA under the State Council
• Entrust qualified medical device lab in China to test the product under application based on PTR

China Agent supports 

China Agents role also supports the following obligations:  

• Report Adverse Events (AEs), investigate and analyze, communication to the local manufacturer and NMPA, and document control
• Periodic risk assessment report 2020
• Annual self check report on its quality system 2022
• Market sampling

Qserve can act as your independent legal representation China Agent with our office in Nanjing and professional local and multi-lingual regulatory experts. You will have direct communication with the Qserve China office, our project managers speak fluent English. 

Information request

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.

Qserve China Agent

Our support for your device registration

Qserve China is a fully established legal company
Facilitation of the complete NMPA registration process
Physical address in mainland of China
First contact point for mutual NMPA communication
Professional local and multi-lingual regulatory experts
Doing submission to NMPA on your behalf
Coordination and follow up until permit is received
Pre- and post-market placement
Support in reporting adverse events and recalls
Help transfer your China agent to the new designation

Qserve is pleased to be your experienced China Agent

How can we help you?

Are you already on the Chinese market?
How do you want us to follow up with you?