What is China Agent?
China Agent is defined as the representative office or the only authorized legal entity in China of the overseas marketing authorization holder (MAH) of the imported medical devices.
The name, address and contact details shall be listed in the medical device registration certificate.
What are the responsibilities of the China agent?
The China agent shall follow the responsibilities:
- The product registration shall be done in the name of China agent
- Monitor and report the adverse events of the registered devices: reporting the adverse events to the overseas MAH, cooperating with the Chinese authorities on the investigation of the adverse events, and reporting overseas adverse events to the Chinese NMPA according to the regulated time.
- Perform the product recall and report the recall to the NMPA.
- Assist the NMPA to inspect the overseas MAH.
- Cooperate with the NMPA to inspection and evaluation of the product quality and provide relevant information
- have the overview of the product import, the sales and the distribution in China and ensure the traceability of the device in China.
- Act as the contact between the NMPA and the overseas MAH and inform the overseas MAH of the relevant regulations and technical requirements.
- Urge and assist the overseas MAH to finish the further requirements of the conditional approval of the devices.
- investigation and process the customer complaint, give feedback to the customer, collect and summarize the compliant information to the overseas MAH
- Other duties required by the NMPA.
It is very important to understand that the China agent has joined responsibilities together with the overseas MAH of the product quality and service.
Who can be the China Agent?
The representative office of the overseas manufacturer or a Chinese company authorized by the overseas manufacturer can be the China agent of the medical device.
For those manufacturers who donot have a rep office in China, it is very common to appoint its exclusive distributor or a service agency to be the China agent.
Often, the Chinese exclusive distributor of an imported medical device would ask for the China agent role together with the exclusive distribution rights, as the China agent must be present on the certificate. In this way, the distributor feels “safer” as the overseas manufacturer can not change the exclusion right so easily.
However, at the beginning of cooperation, both parties (the manufacturer and the Chinese distributor) may have not built the trust. The manufacturer prefers to be more flexible to select the distributor more carefully. It is then recommended to choose a service agent as the China agent to ensure the flexibility.
On the other hand, the manufacturer would like to keep several distributors within the country, it is also common to use an agency to be the China agent.
Also, although the distributors are good at commercializing the products, they donot have the right human resource for the post-market surveillance. Hiring a service agent with the professional regulatory affairs team could fulfill the increasing demanding of post-market surveillance required by the NMPA.
Why to choose JMEDTEC as your China Agent?
JMEDTEC has a professional RA team to fulfill the requirements for post-market surveillance. Besides the regulatory work, we are able to assist you to identify the right distribution channel and partners to establish a better commercial management of distribution network.
Please contact us via info@jmedtec.cn.