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Latest Regulations

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Interim Provisions on Administrative Penalty Procedures for Market Supervision and Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 市监总局令2018年第2号 Supervision & Inspection 2018-12-21 2019-04-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Interim Measures for Administrative Penalty Hearing in Market Supervision and Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 市监总局令2018年第3号 Supervision & Inspection 2018-12-21 2019-04-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Announcement on the Approval and Release of 27 Medical Device Industry Standards, including YY0042-2018 High Frequency Jet Respirator
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第97号 Product Type Testing 2018-12-20 2019-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Issuing Guidelines for Writing Application Materials for Special Review of Innovative Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第127号 Pre-Market 2018-12-18 2018-12-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on soliciting opinions on the draft of four medical device nomenclature guidelines, including the General Principles of Medical Device Naming Terminology Guidelines
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20181218-f1 Pre-Market 2018-12-18 2018-12-18
Status Issued By Level of Legal Effect Product Category Draft National Health … Work Documents Medical Device
Notice on Issuing Two Registration Technical Review Guidelines for Disposable Bilirubin Plasma Adsorbers and Other Items
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第126号-f1 Registration & Filing 2018-12-18 2018-12-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Issuing Guiding Principles for the Review of Two Registration Technologies, including Disposable Biopsy Needles
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第126号-f2 Registration & Filing 2018-12-18 2018-12-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Announcement on soliciting opinions from the public on the "Requirements for Application Materials for Defining the Attributes of Pharmaceutical Device Combination Products (Draft for Soliciting Opinions)"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第226号 Pre-Market 2018-12-14 2018-12-14
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Announcements Combination Product
Announcement on soliciting opinions from the public on the "Requirements for Application Materials for Defining the Attributes of Pharmaceutical Device Combination Products (Draft for Soliciting Opinions)"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第226号 Pre-Market 2018-12-14 2018-12-14
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Announcements Combination Product
Notice of the General Office of the State Administration for Market Regulation on Doing a Good Job in Advertising Review of Drugs, Medical Devices, Health Foods, and Formula Foods for Special Medical Purposes
Regulation No. Product LifeCycle Issued Date Implemented Date 市监广[2018]87号 Supervision & Inspection,Distribution 2018-12-07 2018-12-04
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Normative Documents IVD
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