Medical Equipment

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& acute;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.
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 Ins