The State Food and Drug Administration (SFDA) supervises on the safety and management of drugs, medical devices and cosmetic products in China. All imported medical devices must apply to SFDA for a medical device registration certificate. The Center for Medical Device Evaluation affiliated with the SFDA is responsible for the technological evaluation of medical devices and the China Quality Certification Center is the authority in charge of the issuance of 3C certificates for medical devices.

Medical devices are divided into three categories - Class I, Class II and Class III - with each successive class requiring progressive controls to ensure the safety and effectiveness which are usually divided into two steps; drafting product standards, type testing and conducting clinical trials follow by registration with the SFDA. Overseas manufacturers must entrust a registered representative in China to apply for a registration certificate on their behalf. Our country specific (*) regulatory services in China include:

Medical Device specific regulation strategy reports, Medical Device Registration with SFDA, Chinese Representative and certification holder for Medical Device manufacturers, SFDA Technical documents Preparation including product standard preparation, 3C Certificate compliance and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

For more information, please submit your inquiry or choose to consult our online experts right now.  Let's get your products registered in China!

(*) Chinese Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.