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Provisions for Medical Device Adverse Event Monitoring and Re-evaluation
2019-12-16
The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the National Health Commission, is hereby promulgatedand shall be put into force as of January 1, 2019.
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Provisions for Medical Device Standards (Decree No. 33 of China Food and Drug Administration)
2019-12-16
The Provisions for Medical Device Standards adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, is hereby promulgated and shall be effective as of July 1, 2017.
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Decision of CFDA on Adjusting Approval Procedures for Certain Administrative Examination and Approval Items of Medical Devices (Decree No. 32 of China Food and Drug Administration)
2019-12-16
The Decision of CFDA on Adjusting Approval Procedures for Certain Administrative Examination and Approval Items of Medical Devices adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, is hereby promulgated and shall be effective as of July 1, 2017.
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Amendment to Provisions for In Vitro Diagnostic Reagent Registration (Decree No. 30 of China Food and Drug Administration)
2019-12-16
The Amendment to Provisions for In Vitro Diagnostic Reagent Registration adopted at the executive meeting of China Food and Drug Administration on January 5, 2017, is hereby promulgated and shall be effective as of the date of promulgation.
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Good Clinical Practice for Medical Devices (Decree No. 25 of China Food and Drug Administration and National Health and Family Planning Commission of the People's Republic of China) (Abolished)
2019-12-16
The Provisions for Medical Device Standards adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, is hereby promulgated and shall be effective as of July 1, 2017.
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Rules for Medical Device Nomenclature (Decree No. 19 of China Food and Drug Administration)
2019-12-14
The Rules for Medical Device Nomenclature, adopted at the executive meeting of China Food and Drug Administration on December 8, 2015, is hereby promulgated and shall be effective as of April 1, 2016.