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).
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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 one 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 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.