1. SFDA requires registration and approval of all imported in-vitro diagnostic products prior to
their sales and distribution in China.

2. With the exception of biological reagents that are classified as pharmaceutical products, all
other in-vitro diagnostic products are regulated under the medical devices category.

3. Medical device or Diagnostic companies cannot sell directly in China. They must work through either a third agency, or their own subsidiary distributors registered in China.

Useful SFDA links for medical device: http://eng.sfda.gov.cn/eng

China’s Regulatory Process for In-Vitro Diagnostic (IVD) Products



QiaoBio offers expertise assisting IVD companies for SFDA registration and approval. We
can help you
· Appoint Legal Agent (LA) and After Sales Agent (ASA)
· Meet the requirements of Chinese Quality Management System
· Prepare and submit Chinese Registration Standard to SFDA
· Prepare and submit Import Medical Device Registration Certificate (IMDRC)
· Update on and comply with the SFDA regulatory changes following approval