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 and After Sales
Service Agent (in-country regulatory representative).
Appointed SFDA Legal Agents and After Sales Agents must
be residents of China OR maintain a place of business in
China. RJS Medical Technology Inc. can
act as your Legal Agent and After Sales Agent 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 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 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 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.
RJS Medical Technology Inc. is a professional,
independent China SFDA Legal Agent and After Sales Agent
focused on medical device and IVD regulatory affairs.
