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País:
China
N º de Modelo:
003
Precio FOB:
Lugar de origen:
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Precio de pedido mínimo:
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Cantidad de pedido mínimo:
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Detalle de embalaje:
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El tiempo de entrega:
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Capacidad de suministro:
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Tipo de pago:
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Grupo de productos :
Persona de contacto Mr. George
Rm21B05,No360 Hengtong Rd,Zhabei district, Shanghai, Shanghai
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.
País: | China |
N º de Modelo: | 003 |
Precio FOB: | Obtener el precio más reciente |
Lugar de origen: | - |
Precio de pedido mínimo: | - |
Cantidad de pedido mínimo: | - |
Detalle de embalaje: | - |
El tiempo de entrega: | - |
Capacidad de suministro: | - |
Tipo de pago: | - |
Grupo de productos : | part one |