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Latest Regulations

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Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2024-08-28 2024-08-26
Status Issued By Level of Legal Effect Product Category Draft UNKNOWN UNKNOWN UNKNOWN
Notice of the Comprehensive Department of the National Medical Products Administration on Clarifying Matters Related to the Labeling of Qualification Identification Marks in the Medical Device Inspection Work Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函〔2020〕746号 Product Type Testing 2020-12-08 2020-12-03
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 Guiding Principles for Capacity Building of Medical Device Inspection and Testing Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外[2019]36号 Supervision & Inspection,Product Type Testing 2019-08-30 2019-08-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the State Administration on Doing a Good Job in the Inspection of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]187号 Product Type Testing 2018-01-03 2017-12-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the State Administration on the Clearing Results of Normative Documents Involved in the Reform of "streamlining administration, delegating powers, and improving services"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第136号 Product Type Testing 2017-11-17 2017-11-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2017-05-19 2017-05-04
Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD
Notice of the State Administration of Food and Drug Administration on Issuing the Qualification Recognition Conditions for Medical Device Inspection Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监科[2015]249号 Supervision & Inspection,Product Type Testing 2015-11-04 2015-11-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Opinions of the State Administration for Food and Drug Administration on Strengthening in-process and post supervision of matters related to the cancellation and delegation of administrative approvals
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法[2015]65号 Supervision & Inspection,Product Type Testing 2015-06-09 2015-06-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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