China is one of the world’s largest markets for medical devices and still growing rapidly, making it an important strategic target market for medical device manufacturers worldwide. All medical devices marketed or sold for use in China must be registered with CFDA.
The CFDA classifies Medical Devices into three categories according to their respective risk potential:
• Class I Medical Devices are those for which safety and effectiveness can be ensured through relative simple testing and documentation.
• Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness.
• Class III Medical Devices are those implanted into the human body, or used for life support or sustenance, or pose potential risks to the human body, and thus must be strictly controlled with respect to safety and effectiveness.
For importers, manufacturers exporting medical devices to China must appoint several China-based agents to act on their behalf.