Registering Medical Devices in China: Required Documents

China’s State Drug Administration (SDA), which replaced the State Pharmaceutical Administration of China (SPAC) in 1998, is responsible for supervising the research, production, distribution, and use of pharmaceutics, as well as conducting clinical drug research, monitoring adverse drug reactions, and registering new drugs, generic drugs, imported drugs, and traditional Chinese medicines (TCM). The SDA also has a Department of Medical Devices, which focuses on supervision and control of medical devices.

All medical devices in China are subject to registration. Products are categorized into three classes that are similar to those of the US FDA: Class I products have the lowest degree of risk to the human body, and are subject to less regulation; Class III products are the most invasive, and are susceptible to rigorous controls. Foreign products that have already been approved for market use in their country of origin will receive favorable treatment during registration, while products manufactured in China are subject to the strictest regulatory requirements. SDA approval is valid for four years, and the process theoretically takes about three months – in practice it can be much longer.

In order to register medical devices in China, the following documents must be submitted to the SDA in both English and Chinese, along with a statement guaranteeing the authenticity of the materials submitted:

  1. Application Form for Product Registration
  2. Manufacturing license
  3. Business license
  4. FDA Certificate to foreign government
  5. Letter to guarantee accordance to safety and technical standards
  6. Instruction manual
  7. Product Quality Guarantee
  8. Letter that designates an after-sales service agency in China, the letter of commitment from that company, and their business license
  9. Functional Test Report by an SDA certified medical device testing institution (for Class II and III products only)
  10. Clinical trial reports (usually from the country of origin) for Class II and III products