China SFDA Legal Agent & After Sales Agent

The State Food and Drug Administration (SFDA) of China requires that all medical device, IVD and pharmaceutical companies with no location in the People's Republic of China appoint a registered Legal Agent (LA, in-country regulatory representative) and After Sales Service Agent(ASA). Appointed SFDA LA and ASA must be a legal entity and maintain a place of business in China. SFDA also requires that ASA hold Medical Device Sales License with related scope. Jyton & Emergo Medical Technology Co. Ltd. can act as your LA and ASA in China through our office in Beijing.

Tasks we perform as your SFDA Legal Agent and After Sales Agent in China:

• We act as liaison between you and the SFDA, responding to questions, assisting the SFDA 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 Chinese authorities are the only ones who we will show the documents to, if requested.
• We obtain SFDA certificates and other documentation for each device from SFDA and forward them to you.
• We procure all government import licenses on your behalf.
• We will assist with procurement of renewal registrations (every 4 years).

Can I appoint a distributor as my SFDA 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 will be required to provide all of your technical documentation to the registration agent. Most companies prefer not to put confidential design information in the hands of a sales entity, that often also 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 may get upset.
• 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 SFDA regulatory changes that may affect you?
• If SFDA questions an incident or a non-compliance that occurred involving your device or your company, will your distributor defend his own company or yours?
• Most distributors are not aware of the responsibilities that come with being an After Sales Agent and Legal Agent.

Jyton & Emergo Medical Technology is a professional, independent China SFDA 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.