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GB 9706.1-1995 revised to GB 9706.1-2007 (2008-6-2 (2010-07-14)
A revised \"Regulation on Medical Device Registrat (2010-07-14) Serverce Scope:
Registration for Medical Devices
Registration for Healthy Food
Registration for Pharmaceuticals
Help to find local distributors in China
Regisration for dental items
Registration for Disinfection/Sterilization Produc
Marketing research
clinical Trial service
Registration for IVDWhy you will choose us as your partner
· Headquartered in Beijing, where SFDA offices are located, facilitating effective face-to-face consulting sessions with SFDA officials, tight follow-up of product registration progress,efficient problem -solving thoughout the process of registration,etc.
· Maintains good relationship with testing centers and SFDA divisions;
· A professional registration team, with experience since 1996 in registration of various imported medical products,including but not limited to thoseused in dentistry,neurosurgery, cardiology,orthopaedic and etc; . Value sense of responsibility, efficiency and serve the client best.. Save you labour: we draft required documents based on characteristics of client's product, arrange product tests in China, and follow up registration process;client only needs to provide market approval certificates and manufacturing license(PMA or 510k, CE, KFDA, PMDA, ISO13485, Annual registration of establishment, etc);
· Competitive price;