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Latest Regulations

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Notice of the National Medical Products Administration on Issuing the Operating Norms for Registration and Approval of Class II Medical Devices in China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2021〕54号 Registration & Filing 2021-11-04 2021-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Operating Norms for Registration and Approval of Domestic Class III and Imported Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2021〕53号 Registration & Filing 2021-11-04 2021-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监法[2019]48号 Manufacturing,Distribution,Registration & Filing 2019-11-29 2019-11-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Implementing the Reform Measures of "Separation of Certificates and Licenses" and Further Promoting the Reform of the Medical Device Evaluation and Approval System
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2018]43号 Registration & Filing 2018-11-15 2018-11-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
The General Office of the Communist Party of China Central Committee and the General Office of the State Council have issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices"
Regulation No. Product LifeCycle Issued Date Implemented Date 厅字[2017]42号 Usage,Clinical Evaluation,Registration & Filing 2017-10-08 2017-10-08
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents Combination Product
Interpretation of the Decision on Adjusting the Approval Procedures for Administrative Approval Matters of Certain Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170406 Registration & Filing 2017-04-06 2017-04-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Measures for the Administration of Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2014年第4号 Registration & Filing 2014-07-30 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Departmental Rules Medical Device

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