NMPA China Agent

In 2014 medical device regulation fundamental reformed.
NMPA launched multiple requirements in respect to the responsibilities of acting as NMPA Agent, such as:

• Register product with NMPA
• Coordinate the communication
• Convey relevant regulations and technical requirements to the manufacturer
• Report Adverse Events (AEs) to the manufacture and NMPA

From 1st May 2017
NMPA requires a further Administrative Measure on Medical Device Recall (CFDA No. 29, 2017). This regulation details new responsibility and liability for the manufacturer and its NMPA Agent in case of a recall and require the following joined efforts:

• Actively collecting and reporting adverse events
• Coordinating a recall and correction measures, if it were to happen

To clarify in more details, the foreign manufacturer has:
• The obligations to inform its NMPA China Agent of any case of an Adverse Event directly
• To provide the Agent active reporting depending on the level of events, occuring both in China territory
   as globally with products also sold in China
 
In addition, the foreign manufacturer needs to send China NMPA Agent the following reports in case NMPA is requesting for information:
• Yearly overview on all updates or changes regarding the submitted listed product (group) at NMPA
• Post Market Surveillance report
• Adverse incident AEs, status report

Besides, China agent will also be responsible for:
• product quality
• after-sale related collateral responsibilities