China NPMA / CFDA Approved
Medical Supplies & PPE
Certificate Validation

Home    CFDA Registration   AQSIQ Register   CIQ Inspection   CNCA Registration   NHFPC(MOH) Register   MOA Register      Contact Us

 : China DMF filing Cosmetics    Imported Food Products    Health Food Supplements  Drugs   Medical Device & IVD    Dairy Products   Pet Food     Disinfectant
China SFDA Legal Agent & After Sales Agent of Medical Devices

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.


           Site  Search
Since 1-Sep, 2018, CFDA (China Food and Drug Administration) has changed its name to NMPA (National Medical Product Administration). So, all CFDA and SFDA on this website default mean NMPA.  
Our Service Items
CFDA CFDA Registration for Cosmetics, Health Food, Infant Formula, FSMP , Medical Device, IVD,Drug etc.
AQSIQ  AQSIQ Registration for  Foreign Food Facility and Exporter
CNCA CNCA Registration for Foreign Dairy, Meat, Aquatic Foods Facility
CIQ CIQ Inspection & filing for Foods & Cosmetics Chinese Labeling, Batteries & Coatings Product etc.
MOA CNCA Registration for Foreign Animal Feed, Dog, Cat Food, GMO etc.
MOH MOH Registration for Disinfectant, New Food & Cosmetic Ingredient
GB China National GB Standards English Translation & GB Standards Item Test
Imported Commodity China Regulatory Compliance Review & Consulting
  Our Search Tools
China National GB Standards Search
China HS Code Search
Customs Tariff & Tax Search
CIQ Import Inspection Requirements Search
China Cosmetics Formula Ingredients Analysis System
China Foods Formula Ingredients Analysis System
Guide of How to Export China
Contact Us
Post Message 

Wechat ID: rjschina

  |  Home  |  About Us  |  China CFDA(sfda) Registration   |  China CRO Service  |  China Regulations News  |  Contact Us  |

106# Zhongmao Mansion,No.1 Beizhan Road, Shenzhen,China 518000
©  RJS Copyright  2001-2020 All Rights Reserved&