Which legislation regulates the supervision and administration of medical devices in China?

(State Council Order No. 650), effective June 1, 2014 Order 650 is the highest level regulation governing the registration and record-keeping of medical devices, requirements for product manufacturing and distribution, and liability for illegal behavior. A revised version of the Regulations on the Supervision and Administration of Medical Devices (2000), the 2014 amendment introduces the following reforms of the regulatory regime for medical devices in China:

• Improvement to the risk-based classification system of medical devices 
• Revocation of the re-registration requirements
• Changed order of approval to encourage innovation 
• Heavier punishment for violations
• Stronger after-sales supervision