Table 3.

Filing and Registration of Chinese Medical Device Products

Device class	Risk	Application required NMPA approval
Class I	Low	Filing materials submitted to the department in charge of drug supervision and management of the municipal people's government with districts (Municipal Bureau)
Class II	Moderate	Registration application materials submitted to the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government (Provincial Bureau)
Class III	High	Registration application materials submitted to the drug regulatory authority of the State Council (NMPA)

NMPA, National Medical Products Administration.