The China State Food and Drug Administration (SFDA) requires that all foreign
pharmaceutical, medical device, IVD, Health Food and Cosmetics companies must
appoint a registered Legal Agent (LA, in-country regulatory representative) in
China.
RJS MedTech Inc. can act as your LA in China through our office in
Beijing, Shanghai & Shenzhen.
As your Chinese registered Legal Agent (LA, in-country regulatory
representative), we provide the following service:
1. To determine the exact cosmetics category for your products.
2. To find the best way towards SFDA approval.
3. Professional translation for your documents and labeling.
4. Compiling the Product Registration Standards and Technical files.
5. Final submission preparation
6. Selecting test labs which are SFDA approved，and following up the cosmetics
testing procedures.
7. Following up the SFDA Cosmetics Evaluation Procedures.（Communicate with the
SFDA reviewing officers timely, find out what is missing and do the supplement,
meanwhile, the procedure can be accelerated and so is the success rate. ）
8. Caretaker for all your registration information and documentation
Can I appoint a distributor as my SFDA Agent?
Some manufacturers want authorize distributors in china as their SFDA legal
representative agent, since they think they can save legal representation agent
fee, etc., by this way. However, this will bring you more risk.
1. SFDA legal representative agent must be proficient in SFDA registration
regulations and professional technologies, while the focus of the distributor is
not on that point. Provided that the distributor submitted unqualified technical
data to SFDA, it might cause registration failure to your product, and cause a
waste of time and money. What’s worse, SFDA might think that your providing
fraud data and your facility will be listed in the restricted list; which means
you are not allowed to register your product in a long time and lose the vast
China market.
2. The duration of SFDA cosmetics approval license lasts for 4 years, which
means the duration of the authorization of SFDA legal representative agent is
the same. Since SFDA need the consent and assistance form your prior
distributor, are you sure they will cooperate with you positively? Unless you
will be sure to cooperate with your distributor for more than 4 years or it will
be a lot of trouble if you want to change your distributor or SFDA legal
representative agent.
3. To register your products 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, since they
sometimes also represents other competing companies.
4. What the distributor focus on is sales. Will they keep you updated on SFDA
regulatory changes which are important to you?
5. If SFDA question about an incident or a non-compliance that involving your
Products or your company, will your distributor defend his own company or yours?
6. Most distributors are not aware of the responsibilities of being an After
Sales Agent and Legal Agent.
In view of these, it is an intellichoice to choose a third party which has no
business interests conflicts with you as your own SFDA legal representative
agent.
RJS MedTech Inc. is a professional, independent China SFDA Legal Agent
and After Sales Agent focused on pharmaceutical, medical device, IVD, Health
Food and cosmetics regulatory affairs.
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