ABSTRACT
China’s overall registration framework is under revision and amendment, and certain regulation outlined below may have been revised recently and was updated to September 30, 2020. The prospects for medical device spending are huge. The government has committed heavily in the construction of thousands of hospitals, healthcare centers and clinics, and this will inevitably lead to spending on capital goods, most notably medical devices. China’s regulatory system for medical devices is still in its rapid development phase, which unavoidably leads to a certain degree of difficulty to catch up on the latest regulatory requirement. Product registration submission files are also required to be in Chinese as well. Medical devices refer to the instrument, apparatus, appliance, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles including the needed computer software that are directly or indirectly used on human body.
