In-Country Representation

China Legal Agent and After Sales Agent Representation for Medical Device and IVD Companies With No Local Office in China

The China Food and Drug Administration (CFDA), formerly known as the State Food and Drug Administration (SFDA), requires that all medical device, IVD and pharmaceutical companies with no office (legal entity) in the People's Republic of China appoint a registered Legal Agent and After Sales Service Agent (in-country regulatory representative). Appointed CFDA Legal Agents and After Sales Agents must be residents of China OR maintain a place of business in China. CROXXMORE Medical Device Consulting can act as your Legal Agent (LA) and After Sales Agent (ASA) in China through our office in Shanghai, Ningb, XiaMen, Shenzhen.

CFDA Legal Agent and After Sales Agent services:

• We act as liaison between you and the CFDA, responding to questions, assisting the CFDA in scheduling inspections and helping to resolve problems or delays.

• We act as your primary contact point for all Chinese authorities.

• We report incidents to the proper authorities, in full cooperation with you and your distributors.

• We protect the confidentiality of your documentation. The only entity we will show your documents to is the Chinese authorities, and only if requested.

• We obtain CFDA certificates and other documentation for each device from CFDA and forward them to you.

• We will assist with procurement of renewal registrations (every 4 years).

Can I appoint a distributor as my CFDA Agent?

While it is possible to appoint a distributor located within China to the role of Legal Agent and After Sales Agent, there are many reasons not to do so:

• To register your device(s) you would be required to provide all to your Technical Documentation to the distributor. Most companies prefer not to put confidential design information in the hands of a sales entity that often represents competing companies.

• The name of the After Sales Agent must be printed on your device label and Instructions for Use. If your After Sales Agent is a distributor, your other distributors will not like to see a competitor's information on your labeling.

• If you decide to switch to another distributor, are you sure the old distributor will cooperate in transferring to another Agent?

• The distributor is focused on sales. Will they keep you updated on CFDA regulatory changes that may affect you?

• If CFDA questions an incident or a non-compliance that occurred involving your device or company, will your distributor defend his company or yours?

• Most distributors are not aware of the responsibilities that come with being an After Sales Agent and Legal Agent.

CROXXMORE Medical Device Consulting is a professional, independent China CFDA Legal Agent and After Sales Agent focused on medical device and IVD regulatory affairs. Your success in China is our goal.

Please contact us for more information on Legal Agent and After Sales Agent representation in China.