In order to strengthen the management of medical device registration, standardize the self-test for registration carried out by registration applicants and ensure the orderly implementation of test for medical device registration, the NMPA organized to formulate the Provisions for Self-Test for Medical Device Registration according to the Regulations for the Supervision and Administration of Medical Devices (State Council Decree No.739), Provisions for Medical Device Registration and Filing (SAMR Decree No.47) and Provisions for In-vitro Diagnostic Reagent Registration and Filing (SAMR Decree No.48). The Provisions for Self-Test for Medical Device Registration was issued and implemented on October 22, 2021.