State Drug Administration has formulated the Regulations on Self-Inspection Management for Medical Device Registration in order to strengthen the management of medical device registration, standardize the registration and self-inspection for registered applicants, and ensure the orderly conduct of medical device registration and inspection, in accordance with Regulations on the Supervision and Administration for Medical Devices (Decree No. 739 the State Council) and Measures to the Administration of Registration and Filing for Medical Devices (Decree No. 47 General Administration of Market Supervision), Measures to the Registration and Filing for In vitro Diagnostic Reagents (Decree No. 48 General Administration of Market Supervision). It is hereby published1 and shall come into force as of the date of publication.
It is hereby announced.
State Drug Administration
October 21, 2021
Regulations on Self-Inspection Management for Medical Device Registration.docx
Source: State Drug Administration
It is hereby announced.
State Drug Administration
October 21, 2021
Regulations on Self-Inspection Management for Medical Device Registration.docx
Source: State Drug Administration