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NMPA China Agent

Qserve as your NMPA China Agent representation for medical devices and IVD companies
China NMPA Agent

When is a NMPA agent required?

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

The China agent needs to be an established legal company with a physical address within mainland China. China agent’s name, address, and contact details shall be listed on the application form, product instructions for use, labels of all classes of medical devices, and finally on the approved product certificate. China agent also needs to notify the local authority of clinical investigation within China. 

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Our multilingual experts, Stephanie, Huang, Aibang Yuan and Jane Liang represent Qserve’s global clients as their China Agent and share a time zone with NMPA, ensuring timely communication between all parties.

China Agent responsibilities

NMPA replaced the Medical Device Regulations Order 680, 2018 by implementing the Regulation for Medical Device Administration and Supervision (State Council Order 739). The new regulation addresses the revised China agent role and responsibilities.  

The China agent assists the foreign legal manufacturer to perform the following obligations:
• Establish a quality management system (QMS) suitable for products and maintain effective operation.
• Formulate plans for post-market studies and risk control and ensure its effective implementation.
• Carry out adverse event monitoring and re-evaluation according to the regulation.
• Establish and implement product traceability and a recall system.
• Other obligations stipulated by NMPA under the State Council
• Entrust a qualified medical device lab in China to test the product under application based on Product Technical Requirement (PTR).
Engaging with Qserve  

Your independent and reliable NMPA China Agent 

  • Qserve China is a fully established legal company
  • Physical address in the mainland of China
  • Act as your independent legal representation
  • Your first contact point for communication with the NMPA
  • Direct communication with the Qserve China office in Nanjing
  • Professional local and multi-lingual regulatory experts who speak fluent English

Download Qserve China Agent leaflet

Searching for an experienced NMPA China Agent?

Our multilingual experts are pleased to help you out.

More information

China Agent roles

Other roles China agent may take

  • Submit the device registration/filing application to the health authority on behalf of the foreign manufacturer.
  • Maintain communication between the health authority and foreign applicants.
  • Inform relevant regulations and technical requirements to foreign applicants faithfully and correctly.
  • Help review and submit China PSUR (period safety update report) annually.
  • File the local clinical investigation plan prior study to the authority if applicable.
  • Support the annual market sampling program.
  • Support the authority’s overseas inspection.
  • Collect adverse events to foreign applicants.
  • Register in the national electronic submission system and equip with the competent authority.
  • Register in the national adverse event system.
Certificate change notification to NMPA 

Do you want to change from China Agent?

Qserve can support the change of appointed China agent will trigger a certificate change notification to NMPA.

 

China agent could be changed by the listed license holder/legal manufacturer once agreed with the new China agent. The new agent may file the agent change to the health authority once authorized by the legal manufacturer.  

China agent is sometimes confusingly mixed with the 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 distributors 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 NMPA China Agent

Our support for your NMPA medical device registration

Take all the binding roles and responsibilities as China agent
First contact point for mutual NMPA communication
Facilitation of the complete NMPA registration process with in-house expertise
Local and native speaking China team
Doing submission to NMPA on your behalf
Support in reporting adverse events and recalls
Help transfer your China agent to the new designation
Established procedures to ensure proper handling of the products
Separate regulatory requirement (China agent) from commercial operation (local distributor)